scholarly journals Use of Featforward Mobile Phone App Associated with Decreased Cardiometabolic Risk Factors in Patients with Chronic Conditions (Preprint)

2018 ◽  
Author(s):  
Sara B Golas ◽  
Ramya Palacholla ◽  
Amanda Centi ◽  
Odeta Dyrmishi ◽  
Stephen Agboola ◽  
...  
Keyword(s):  
Physical Activity ◽  
Mobile Phone ◽  
Chronic Conditions ◽  
Primary Outcome ◽  
Fasting Blood Glucose ◽  
Intervention Group ◽  
Step Count ◽  
Control Group ◽  
Activity Trackers ◽  
Secondary Outcomes

BACKGROUND Physical inactivity is one of the leading risk factors contributing to rising rates of chronic diseases and has been associated with deleterious health outcomes in patients with chronic disease conditions. FeatForward is a mobile phone app designed to encourage patients with cardiometabolic risk (CMR) factors to increase their levels of physical activity. OBJECTIVE To evaluate the effect of the FeatForward mobile phone app on physical activity levels (primary outcome) and global CMR factors (secondary outcomes) in patients with chronic conditions. METHODS In this 6-month, 2-arm randomized controlled trial, adult participants endorsing at least 1 study-eligible condition (obesity, [pre-]diabetes, [pre-]hypertension) were enrolled and assigned to either the intervention group (FeatForward app and standard care) or control group (standard care only). The primary and secondary outcomes were, respectively, change from baseline in physical activity (step count) and CMR factors (weight, body mass index [BMI], waist circumference, glycated hemoglobin [HbA1c], fasting blood glucose, systolic/diastolic blood pressures, serum lipids, C-reactive protein [CRP]). CMR data were collected at 3 time-points: baseline, 3 months, and 6 months. Step count data were recorded continuously by patients’ study-issued activity trackers and collected in batches at 3 and 6 months. At study end, patients’ weekly average step counts (WAS) were calculated as total steps taken divided by days of step data (0-7) for each of 26 study weeks. Mixed-effects linear regression models evaluated change over time between groups for the primary outcome and secondary outcomes. All models controlled for baseline values. The step count model additionally controlled for proportion of days without data, defined as (7 – days of data) / 7. Analyses were conducted for both groups overall, and by disease cohort (obesity, diabetes, hypertension). RESULTS Step count and CMR data were analyzed for 128 intervention and 133 control patients. There were no demographic differences between groups. While there was an overall downward trend in WAS for both groups, the intervention group decreased significantly less than the control group, with a slope of -29.3 steps per week compared to controls’ -57.9 (P=.02). Intervention patients with obesity slightly increased their step count overtime, differing significantly from controls (slope of 0.9 vs -90.2; P<.001). Intervention patients significantly lowered their BMI per study month compared to controls (slopes -0.23 vs -0.02; P=.04). Additionally, intervention patients with hypertension significantly decreased weight (P=.003), BMI (P=.002), and CRP (P=.03) per month compared to the control group. Waist circumference, HbA1c, fasting blood glucose, blood pressure, and lipids did not differ significantly by group or disease cohort over time. CONCLUSIONS While it is common for patient engagement with physical activity trackers to decrease over the course of a study, patients using the FeatFoward app had a slower decline in physical activity compared to controls. Intervention patients experienced a reduction in their BMI from a mean of 34.3 to 33.4, compared to controls’ 34.8 to 35.0. Patients with hypertension experienced significant decreases in BMI, weight, and CRP compared to controls. Future analyses will evaluate the impact of app engagement levels on step counts and CMR factors for the intervention group.

P573Effects of mobile text messaging on glycemic control in patients with coronary heart disease and diabetes mellitus: a randomized controlled trial

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
X H Huo ◽  
H M K Krumholz ◽  
X B Bai ◽  
E S S Spatz ◽  
Q D Ding ◽  
...  
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Coronary Heart Disease ◽  
Text Messaging ◽  
Hba1c Level ◽  
Primary Outcome ◽  
Intervention Group ◽  
Control Group ◽  
Secondary Outcomes

Abstract Background Mobile health interventions hold the prospect to support risk factor and lifestyle modification and are readily scalable in healthcare systems. Purpose We aim to assess whether text messaging program can improve glycemic control in high-risk patients with coronary heart disease (CHD) and diabetes mellitus (DM). Methods The study was a multi-centre randomised clinical trial conducted at 34 clinics in China. 502 individuals with both CHD and DM were recruited and randomly assigned to either the text messaging intervention (n=251) or control group (n=251). The control group received 2 thank-you messages per month in addition to usual care. The intervention group received 6 messages per week for 6 months. Messages provided educational and motivational information related to glucose monitoring, BP control, physical activity and lifestyle recommendations. The primary outcome was change in glycemic hemoglobin (HbA1C) from baseline to 6 months. Results Follow-up rate was 99%. At 6 months, HbA1C was significantly lower in intervention group compared to control group (mean HbA1C 6.7% vs. 7.2%, P<0.001), with a mean change of −0.2% and 0.1% from baseline, respectively (mean absolute change −0.3% [95% CI −0.5 to 0.1]; P=0.003). Significantly more participants in intervention group achieved a HbA1c<7% (69.3% vs. 52.6%; P=0.004), and change in FBG was larger in intervention group (−0.5 vs. 0.1 mmol/L; P=0.011). No differences in SBP, LDL-C, BMI and physical activity were observed. Almost all patients reported messages to be easy to understand (97.1%) and useful (94.1%). Table 1. Primary and Secondary Outcomes Analyses at 6 Month Follow-up Parameter Intervention (N=251) Control (N=251) Mean Difference in Change P value for Baseline 6 Months Mean Change Baseline 6 Months Mean Change (95% CI) Difference in Change Primary Outcome HbA1C level, %, mean (SD) 6.9 (1.4) 6.7 (1.3) −0.2 (1.0) 7.1 (1.4) 7.2 (1.5) 0.1 (1.1) −0.3 (−0.5, −0.1) 0.003 Secondary Outcomes HbA1C level<7%, No. (%) 155 (62.0%) 174 (69.3%) – 139 (56.1%) 132 (52.6%) – 1.2 (1.1, 1.3)a 0.004   FBG, mmol/L, mean (SD) 8.1 (2.7) 7.5 (2.7) −0.5 (2.5) 8.5 (3.0) 8.6 (3.3) 0.1 (3.1) −0.6 (−1.1, −0.2) 0.011   SBP, mmHg, mean (SD) 135.9 (18.4) 134.7 (18.7) −1.4 (17.1) 135.9 (18.1) 132.2 (17.7) −3.5 (17.8) 2.4 (−0.8,5.5) 0.144   LDL-C, mmol/L, mean (SD) 2.6 (0.8) 2.5 (0.7) −0.1 (0.7) 2.6 (0.8) 2.5 (0.8) −0.1 (0.7) 0 (−0.1, 0.1) 0.828   BMI, mean (SD) 26.4 (3.2) 26.3 (3.5) −0.1 (2.1) 26.3 (3.2) 26.0 (3.4) −0.4 (2.5) 0.3 (−0.1, 0.7) 0.213   Physical activity (MET min/wk), 1386 1386 177 1386 1386 322 −70.7 0.784     median (IQR) (693–3066) (918–3612) (2840) (693–3066) (693–3002) (2635) (−574.9, 433.5) Conclusion Use of a simple, culturally sensitive mobile text-messaging program could be an effective and scalable way to improve disease self-management among patients with CHD and DM. Acknowledgement/Funding Research Special Fund for Public Welfare Industry of Health (201502009) from the National Health and Family Planning Commission of China

scholarly journals Healthy eating and lifestyle in pregnancy (HELP): a cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum

2021 ◽  
Author(s):  
Sharon A. Simpson ◽  
Elinor Coulman ◽  
Dunla Gallagher ◽  
Karen Jewell ◽  
David Cohen ◽  
...  
Keyword(s):  
Weight Management ◽  
Healthy Eating ◽  
Primary Outcome ◽  
Intervention Group ◽  
Control Group ◽  
Risky Drinking ◽  
Management Intervention ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Weight Management Intervention

Abstract Objective To assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth. Methods Pragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined. Interventions Women attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy. Results Mean (SD) BMI at 12 months postpartum was 36.0 kg/m2 (5.2) in the control group, and 37.5 kg/m2 (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was −0.02 (95% CI −0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p < 0.04), improved fibre score (3.22, 1.07 to 5.37, p < 0.01) and lower levels of risky drinking at 12 months postpartum compared to the control group (OR 0.45, 0.27 to 0.74, p < 0.002). The net incremental monetary benefit was not statistically significantly different between arms, although the probability of the intervention being cost-effective was above 60%, at policy-relevant thresholds. Conclusions There was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking. Trial registration: Current Controlled Trials ISRCTN25260464.

scholarly journals Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Russell Jago ◽  
Byron Tibbitts ◽  
Kathryn Willis ◽  
Emily Sanderson ◽  
Rebecca Kandiyali ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

scholarly journals Awareness Development and Usage of Mobile Health Technology Among Individuals With Hypertension in a Rural Community of Bangladesh: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Yasmin Jahan ◽  
Md Moshiur Rahman ◽  
Abu S G Faruque ◽  
Mohammod Jobayer Chisti ◽  
Kana Kazawa ◽  
...  
Keyword(s):  
Physical Activity ◽  
Health Education ◽  
Rural Community ◽  
Text Messaging ◽  
Primary Outcome ◽  
Salt Intake ◽  
Control Group ◽  
Behavior Changes ◽  
Secondary Outcomes ◽  
Sms Text Messaging

BACKGROUND Hypertension (HTN) is a major modifiable risk factor and the leading cause of premature deaths globally. The lack of awareness and knowledge have been identified as risk factors in low- and middle-income countries including Bangladesh. Recently, the use of mobile phone SMS text messaging is found to have an important positive impact on HTN management. OBJECTIVE The study aimed to develop awareness and knowledge in order to enhance lifestyle behavior changes among individuals with HTN in a rural community of Bangladesh by using health education and mobile health (mHealth) technology (SMS text messaging). METHODS A prospective randomized 5-month intervention, open-label (1:1), parallel-group trial was implemented among the individuals with HTN aged 35 years or older. Both men and women were included. Between August 2018 and July 2019, we enrolled 420 participants, selected from a tertiary level health facility and through door-to-door visits by community health workers. After block randomization, they were assigned to either the intervention group (received SMS text messaging and health education; n=209) or the control group (received only health education; n=211). The primary outcome was the evaluation of self-reported behavior changes (salt intake, fruits and vegetables intake, physical activity, and blood pressure [BP], and body weight monitoring behaviors). The secondary outcomes were measurements of actual salt intake and dietary salt excretion, blood glucose level, BP values, and quality of life (QOL). RESULTS During the study period, a total of 8 participants were dropped, and the completion rate was 98.0% (412/420). The adherence rates were significantly higher (9%) among the control group regarding salt intake (<i>P</i>=.04) and physical activity behaviors (<i>P</i>&lt;.03), and little differences were observed in other behaviors. In primary outcome, the focused behavior, salt intake less than 6 g/day, showed significant chronological improvement in both groups (<i>P</i>&lt;.001). The fruits intake behavior steadily improved in both groups (<i>P</i>&lt;.001). Participants in both groups had a custom of vegetables intake everyday/week. Physical activity suddenly increased and continued until the study end (<i>P</i>&lt;.001 in both groups). Both BP and body weight monitoring status increased from baseline to 1 month but decreased afterward (<i>P</i>&lt;.001). In case of secondary outcomes, significant chronological changes were observed in food salt concentration and urinary salinity between the groups (<i>P</i>=.01). The mean systolic BP and diastolic BP significantly chronologically decreased in both groups (systolic BP, <i>P</i>=.04; diastolic BP, <i>P</i>=.02.<i>P</i>&lt;.05). All of these supported self-reported behavior changes. For the QOL, both groups showed significant improvement over the study periods (<i>P</i>&lt;.001). CONCLUSIONS Based on these results, we suggest that face-to-face health education requires integration of home health care provision and more relevant and timely interactive SMS text messages to increase the effectiveness of the intervention. Besides, community awareness can be created to encourage “low-salt culture” and educate family members. CLINICALTRIAL Bangladesh Medical Research Council (BMRC) 06025072017; ClinicalTrials.gov NCT03614104; https://clinicaltrials.gov/ct2/show/NCT03614104 and UMIN-CTR R000033736; https://tinyurl.com/y48yfcoo INTERNATIONAL REGISTERED REPORT RR2-10.2196/15523

scholarly journals Web-Based Physical Activity Intervention for COPD: Differences Between Rural and Urban Veterans

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 497-497
Author(s):  
Stephanie Robinson ◽  
Stephanie Shimada ◽  
Caroline Richardson ◽  
Marilyn Moy
Keyword(s):  
Physical Activity ◽  
Behavior Change ◽  
Physical Activity Intervention ◽  
Community Intervention ◽  
Intervention Group ◽  
Step Count ◽  
Control Group ◽  
Step Counts ◽  
Rural And Urban ◽  
Count Change

Abstract Physical activity is recommended for all patients with chronic obstructive pulmonary disease (COPD), a disease prevalent among older adults. Rural Veterans often lack access to in-person services to support behavior change. Technology can be used to overcome these barriers. This secondary analysis of a randomized controlled trial compared engagement (weekly website-logons) and efficacy (step-count change) measures of a 4-month technology-based physical activity intervention between rural and urban Veterans with COPD. Rural-urban commuting codes (RUCA) were used to classify participants (N=239; mean age=66.7±8.84 years) as ‘rural’ or ‘urban’. Participants were randomized 2:1 to a pedometer and website with iterative, individualized step-count feedback and goals, motivational and informational messages, and an online community (intervention group, n=155, 45.8% rural) or to receive a pedometer-alone (waitlist-control group, n=84, 44% rural). General linear modeling estimated the adjusted effect of rurality on intervention response. There was no significant rural-urban difference in weekly website-logons (3.33 vs. 3.17; p=.364). There was a significant interaction between rurality and group on step-count change (p=.045). Among rural participants, both intervention and controls increased their step counts (567.32 vs. 732.30; p=.769). Among urban participants, the intervention group demonstrated a significantly higher change in step-counts compared to controls (1052.67 vs. -313.57; p=.008). Results suggest that rural participants increased their step-counts similarly whether they received a pedometer alone or used the intervention, whereas only urban participants who used the intervention increased their step counts. It is possible that simply receiving the pedometer alone was sufficient for behavior change in the rural participants.

scholarly journals Adding emollient bath additives to standard eczema management for children with eczema: the BATHE RCT

2018 ◽  
Vol 22 (57) ◽  
pp. 1-116 ◽  
Author(s):  
Miriam Santer ◽  
Kate Rumsby ◽  
Matthew J Ridd ◽  
Nick A Francis ◽  
Beth Stuart ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Primary Outcome ◽  
Intervention Group ◽  
Additive Group ◽  
Health Technology ◽  
Control Group ◽  
Open Label ◽  
Secondary Outcomes ◽  
Bath Additives

BackgroundChildhood eczema is very common. Treatment often includes emollient bath additives, despite there being little evidence of their effectiveness.ObjectivesTo determine the clinical effectiveness and cost-effectiveness of emollient bath additives in the management of childhood eczema.DesignPragmatic, randomised, open-label, multicentre superiority trial with two parallel groups.SettingNinety-six general practices in Wales, the west of England and southern England. Invitation by personal letter or opportunistically.ParticipantsChildren aged between 12 months and 12 years fulfilling the UK Diagnostic Criteria for Atopic Eczema. Children with inactive or very mild eczema (a score of ≤ 5 on the Nottingham Eczema Severity Scale) were excluded, as were children who bathed less than once per week or whose parents/carers were not prepared to accept randomisation.InterventionsThe intervention group were prescribed bath additives by their usual clinical team and were asked to use them regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued standard eczema management, including regular leave-on emollients and topical corticosteroids (TCSs) when required.Main outcome measuresThe primary outcome was eczema control measured by Patient Oriented Eczema Measure [POEM, 0 (clear) to 28 (severe)] weekly for 16 weeks. The secondary outcomes were eczema severity over 1 year (4-weekly POEM), number of eczema exacerbations, disease-specific quality of life (QoL) (Dermatitis Family Impact Questionnaire), generic QoL (Child Health Utility-9 Dimensions) and type and quantity of topical steroid/calcineurin inhibitors prescribed. Children were randomised (1 : 1) using online software to either bath additives plus standard eczema care or standard eczema care alone, stratified by recruiting centre, and there was open-label blinding.ResultsFrom December 2014 to May 2016, 482 children were randomised: 51% were female, 84% were white and the mean age was 5 years (n = 264 in the intervention group,n = 218 in the control group). Reported adherence to randomised treatment allocation was > 92% in both groups, with 76.7% of participants completing at least 12 (80%) of the first 16 weekly questionnaires for the primary outcome. Baseline POEM score was 9.5 [standard deviation (SD) 5.7] in the bath additives group and 10.1 (SD 5.8) in the no bath additives group. Average POEM score over the first 16 weeks was 7.5 (SD 6.0) in the bath additives group and 8.4 (SD 6.0) in the no bath additives group, with no statistically significant difference between the groups. After controlling for baseline severity and confounders (ethnicity, TCS use, soap substitute use) and allowing for clustering of participants within centres and responses within participants over time, POEM scores in the no bath additive group were 0.41 points higher than in the bath additive group (95% confidence interval –0.27 to 1.10), which is well below the published minimal clinically important difference of 3 points. There was no difference between groups in secondary outcomes or in adverse effects such as redness, stinging or slipping.LimitationsSimple randomisation resulted in an imbalance in baseline group size, although baseline characteristics were well balanced between groups.ConclusionThis trial found no evidence of clinical benefit of including emollient bath additives in the standard management of childhood eczema.Future workFurther research is required on optimal regimens of leave-on emollients and the use of emollients as soap substitutes.Trial registrationCurrent Controlled Trials ISRCTN84102309.FundingThis project was funded by the NIHR Health Technology Assessment Programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 57. See the NIHR Journals Library website for further project information.

scholarly journals Adding web-based behavioural support to exercise referral schemes for inactive adults with chronic health conditions: the e-coachER RCT

2020 ◽  
Vol 24 (63) ◽  
pp. 1-106
Author(s):  
Adrian H Taylor ◽  
Rod S Taylor ◽  
Wendy M Ingram ◽  
Nana Anokye ◽  
Sarah Dean ◽  
...  
Keyword(s):  
Physical Activity ◽  
Primary Outcome ◽  
Vigorous Physical Activity ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Web Based ◽  
Exercise Referral ◽  
Exercise Referral Scheme ◽  
Quality Adjusted Life

Background There is modest evidence that exercise referral schemes increase physical activity in inactive individuals with chronic health conditions. There is a need to identify additional ways to improve the effects of exercise referral schemes on long-term physical activity. Objectives To determine if adding the e-coachER intervention to exercise referral schemes is more clinically effective and cost-effective in increasing physical activity after 1 year than usual exercise referral schemes. Design A pragmatic, multicentre, two-arm randomised controlled trial, with a mixed-methods process evaluation and health economic analysis. Participants were allocated in a 1 : 1 ratio to either exercise referral schemes plus e-coachER (intervention) or exercise referral schemes alone (control). Setting Patients were referred to exercise referral schemes in Plymouth, Birmingham and Glasgow. Participants There were 450 participants aged 16–74 years, with a body mass index of 30–40 kg/m2, with hypertension, prediabetes, type 2 diabetes, lower limb osteoarthritis or a current/recent history of treatment for depression, who were also inactive, contactable via e-mail and internet users. Intervention e-coachER was designed to augment exercise referral schemes. Participants received a pedometer and fridge magnet with physical activity recording sheets, and a user guide to access the web-based support in the form of seven ‘steps to health’. e-coachER aimed to build the use of behavioural skills (e.g. self-monitoring) while strengthening favourable beliefs in the importance of physical activity, competence, autonomy in physical activity choices and relatedness. All participants were referred to a standard exercise referral scheme. Primary outcome measure Minutes of moderate and vigorous physical activity in ≥ 10-minute bouts measured by an accelerometer over 1 week at 12 months, worn ≥ 16 hours per day for ≥ 4 days including ≥ 1 weekend day. Secondary outcomes Other accelerometer-derived physical activity measures, self-reported physical activity, exercise referral scheme attendance and EuroQol-5 Dimensions, five-level version, and Hospital Anxiety and Depression Scale scores were collected at 4 and 12 months post randomisation. Results Participants had a mean body mass index of 32.6 (standard deviation) 4.4 kg/m2, were referred primarily for weight loss and were mostly confident self-rated information technology users. Primary outcome analysis involving those with usable data showed a weak indicative effect in favour of the intervention group (n = 108) compared with the control group (n = 124); 11.8 weekly minutes of moderate and vigorous physical activity (95% confidence interval –2.1 to 26.0 minutes; p = 0.10). Sixty-four per cent of intervention participants logged on at least once; they gave generally positive feedback on the web-based support. The intervention had no effect on other physical activity outcomes, exercise referral scheme attendance (78% in the control group vs. 75% in the intervention group) or EuroQol-5 Dimensions, five-level version, or Hospital Anxiety and Depression Scale scores, but did enhance a number of process outcomes (i.e. confidence, importance and competence) compared with the control group at 4 months, but not at 12 months. At 12 months, the intervention group incurred an additional mean cost of £439 (95% confidence interval –£182 to £1060) compared with the control group, but generated more quality-adjusted life-years (mean 0.026, 95% confidence interval 0.013 to 0.040), with an incremental cost-effectiveness ratio of an additional £16,885 per quality-adjusted life-year. Limitations A significant proportion (46%) of participants were not included in the primary analysis because of study withdrawal and insufficient device wear-time, so the results must be interpreted with caution. The regression model fit for the primary outcome was poor because of the considerable proportion of participants [142/243 (58%)] who recorded no instances of ≥ 10-minute bouts of moderate and vigorous physical activity at 12 months post randomisation. Future work The design and rigorous evaluation of cost-effective and scalable ways to increase exercise referral scheme uptake and maintenance of moderate and vigorous physical activity are needed among patients with chronic conditions. Conclusions Adding e-coachER to usual exercise referral schemes had only a weak indicative effect on long-term rigorously defined, objectively assessed moderate and vigorous physical activity. The provision of the e-coachER support package led to an additional cost and has a 63% probability of being cost-effective based on the UK threshold of £30,000 per quality-adjusted life-year. The intervention did improve some process outcomes as specified in our logic model. Trial registration Current Controlled Trials ISRCTN15644451. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 63. See the NIHR Journals Library website for further project information.

scholarly journals Short-term effect of a chronic pain self-management intervention delivered by an easily accessible primary healthcare service: a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e023017 ◽  
Author(s):  
Torunn Hatlen Nøst ◽  
Aslak Steinsbekk ◽  
Ola Bratås ◽  
Kjersti Grønning
Keyword(s):  
Chronic Pain ◽  
Healthcare Service ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Patient Activation ◽  
Self Management ◽  
Control Group ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectivesTo investigate the effects on persons with chronic pain after 3 months of a group-based chronic pain self-management course compared with a drop-in, low-impact outdoor physical group activity on patient activation and a range of secondary outcomes.DesignAn open, pragmatic, parallel group randomised controlled trial. Analyses were performed using a two-level linear mixed model.SettingAn easily accessible healthcare service provided by Norwegian public primary healthcare.ParticipantsA total of 121 participants with self-reported chronic pain for 3 months or more were randomised with 60 participants placed in the intervention group and 61 placed in the control group (mean age 53 years, 88% women, 63% pain for 10 years or more).InterventionsThe intervention group was offered a group-based chronic pain self-management course with 2.5-hour weekly sessions for a period of 6 weeks. The sessions consisted of education, movement exercises and emphasised group discussions. The control group was offered a low-impact outdoor group physical activity in 1-hour weekly sessions that consisted of walking and simple strength exercises for a period of 6 weeks.Main outcomesThe primary outcome was patient activation assessed using the Patient Activation Measure. Secondary outcomes measured included assessments of pain, anxiety and depression, pain self-efficacy, sense of coherence, health-related quality of life, well-being and the 30 s chair to stand test.ResultsThere was no effect after 3 months of the group-based chronic pain self-management course compared with the control group for the primary outcome, patient activation (estimated mean difference: −0.5, 95% CI –4.8 to 3.7, p=0.802).ConclusionsThere was no support for the self-management course having a better effect after 3 months than a low-impact outdoor physical activity offered the control group.Trial registration numberNCT02531282; Results.

scholarly journals INCREASING PHYSICAL ACTIVITY POST-KIDNEY TRANSPLANT: A PILOT RANDOMIZED CONTROLLED TRIAL

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S521-S521
Author(s):  
Tara O’Brien ◽  
Cynthia Russell ◽  
Donna Hathaway
Keyword(s):  
Physical Activity ◽  
Kidney Transplant ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Randomized Controlled ◽  
Activity Trackers ◽  
Pilot Randomized Controlled Trial

Abstract Older kidney transplant recipients are at risk for graft failure and death due to lack of physical activity. Physical activity after transplant is the most modifiable non-pharmacological factor for improving physical function. One personal system intervention called, SystemCHANGE™ in combination with activity trackers, holds promise for increasing physical activity among this population. The purpose of this pilot randomized controlled trial was to evaluate the efficacy of SystemCHANGE™ on increasing average daily steps in older (age 60 and over) kidney transplant recipients from baseline to 6 months. The intervention group met monthly to implement a successful personal system solution based on their daily routines and step-data collected from the activity tracker. The control group received monthly educational information on healthy living with a transplant. Participants were randomized 1:1 to the intervention or control group. The sample consisted of 31 participants (n = 15 intervention, and n = 16 control). No significant differences were found at baseline among the groups for demographics, self-efficacy and health outcomes (blood pressure, weight, waist circumference, 6 minute Walk Test). However, the intervention group had greater increase in the average daily steps from baseline to 6 months (mean ± SD: 1511 ± 2320) as compared to the control group (181 ± 2419). The between-group difference was of medium effect size (d = .56).The data suggests SystemCHANGE™ in combination with activity trackers may be feasible for older kidney transplant recipients to enhance daily steps.

scholarly journals Awareness Development and Usage of Mobile Health Technology Among Individuals With Hypertension in a Rural Community of Bangladesh: Randomized Controlled Trial

10.2196/19137 ◽  
2020 ◽  
Vol 22 (12) ◽  
pp. e19137
Author(s):  
Yasmin Jahan ◽  
Md Moshiur Rahman ◽  
Abu S G Faruque ◽  
Mohammod Jobayer Chisti ◽  
Kana Kazawa ◽  
...  
Keyword(s):  
Physical Activity ◽  
Health Education ◽  
Rural Community ◽  
Text Messaging ◽  
Primary Outcome ◽  
Salt Intake ◽  
Control Group ◽  
Behavior Changes ◽  
Secondary Outcomes ◽  
Sms Text Messaging

Background Hypertension (HTN) is a major modifiable risk factor and the leading cause of premature deaths globally. The lack of awareness and knowledge have been identified as risk factors in low- and middle-income countries including Bangladesh. Recently, the use of mobile phone SMS text messaging is found to have an important positive impact on HTN management. Objective The study aimed to develop awareness and knowledge in order to enhance lifestyle behavior changes among individuals with HTN in a rural community of Bangladesh by using health education and mobile health (mHealth) technology (SMS text messaging). Methods A prospective randomized 5-month intervention, open-label (1:1), parallel-group trial was implemented among the individuals with HTN aged 35 years or older. Both men and women were included. Between August 2018 and July 2019, we enrolled 420 participants, selected from a tertiary level health facility and through door-to-door visits by community health workers. After block randomization, they were assigned to either the intervention group (received SMS text messaging and health education; n=209) or the control group (received only health education; n=211). The primary outcome was the evaluation of self-reported behavior changes (salt intake, fruits and vegetables intake, physical activity, and blood pressure [BP], and body weight monitoring behaviors). The secondary outcomes were measurements of actual salt intake and dietary salt excretion, blood glucose level, BP values, and quality of life (QOL). Results During the study period, a total of 8 participants were dropped, and the completion rate was 98.0% (412/420). The adherence rates were significantly higher (9%) among the control group regarding salt intake (P=.04) and physical activity behaviors (P<.03), and little differences were observed in other behaviors. In primary outcome, the focused behavior, salt intake less than 6 g/day, showed significant chronological improvement in both groups (P<.001). The fruits intake behavior steadily improved in both groups (P<.001). Participants in both groups had a custom of vegetables intake everyday/week. Physical activity suddenly increased and continued until the study end (P<.001 in both groups). Both BP and body weight monitoring status increased from baseline to 1 month but decreased afterward (P<.001). In case of secondary outcomes, significant chronological changes were observed in food salt concentration and urinary salinity between the groups (P=.01). The mean systolic BP and diastolic BP significantly chronologically decreased in both groups (systolic BP, P=.04; diastolic BP, P=.02.P<.05). All of these supported self-reported behavior changes. For the QOL, both groups showed significant improvement over the study periods (P<.001). Conclusions Based on these results, we suggest that face-to-face health education requires integration of home health care provision and more relevant and timely interactive SMS text messages to increase the effectiveness of the intervention. Besides, community awareness can be created to encourage “low-salt culture” and educate family members. Trial Registration Bangladesh Medical Research Council (BMRC) 06025072017; ClinicalTrials.gov NCT03614104; https://clinicaltrials.gov/ct2/show/NCT03614104 and UMIN-CTR R000033736; https://tinyurl.com/y48yfcoo International Registered Report Identifier (IRRID) RR2-10.2196/15523

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