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 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.

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 Effect of text messaging on depression in patients with coronary heart disease: a substudy analysis from the TEXT ME randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e022637 ◽  
Author(s):  
Sheikh Mohammed Shariful Islam ◽  
Clara K Chow ◽  
Julie Redfern ◽  
Cindy Kok ◽  
Karin Rådholm ◽  
...  
Keyword(s):  
Physical Activity ◽  
Coronary Heart Disease ◽  
Text Messaging ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Support Programme ◽  
History Of ◽  
Randomised Controlled ◽  
History Of Depression

ObjectiveWe aimed to evaluate the effects on depression scores of a lifestyle-focused cardiac support programme delivered via mobile phone text messaging among patients with coronary heart disease (CHD).DesignSubstudy and secondary analysis of a parallel-group, single-blind randomised controlled trial of patients with CHD.SettingA tertiary hospital in Sydney, Australia.InterventionThe Tobacco, Exercise and dieT MEssages programme comprised four text messages per week for 6 months that provided education, motivation and support on diet, physical activity, general cardiac education and smoking, if relevant. The programme did not have any specific mental health component.OutcomesDepression scores at 6 months measured using the Patient Health Questionnaire-9 (PHQ-9). Treatment effect across subgroups was measured using log-binomial regression model for the binary outcome (depressed/not depressed, where depressed is any score of PHQ-9 ≥5) with treatment, subgroup and treatment by subgroup interaction as fixed effects.ResultsDepression scores at 6 months were lower in the intervention group compared with the control group, mean difference 1.9 (95% CI 1.5 to 2.4, p<0.0001). The frequency of mild or greater depressive symptoms (PHQ-9 scores≥5) at 6 months was 21/333 (6.3%) in the intervention group and 86/350 (24.6%) in the control group (relative risk (RR) 0.26, 95% CI 0.16 to 0.40, p<0.001). This proportional reduction in depressive symptoms was similar across groups defined by age, sex, education, body mass index, physical activity, current smoking, current drinking and history of depression, diabetes and hypertension. In particular, the rates of PHQ-9 ≥5 among people with a history of depression were 4/44 (9.1%) vs 29/62 (46.8%) in intervention vs control (RR 0.19, 95% CI 0.07 to 0.51, p<0.001), and were 17/289 (5.9%) vs 57/288 (19.8%) among others (RR 0.30, 95% CI 0.18 to 0.50, p<0.001).ConclusionsAmong people with CHD, a cardiac support programme delivered via mobile phone text messaging was associated with fewer symptoms of mild-to-moderate depression at 6 months in the treatment group compared with controls.Trial registration numberACTRN12611000161921.

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

Increasing Physical Activity in Persons With Dementia: A Randomized Controlled Trial

2020 ◽  
Vol 28 (4) ◽  
pp. 588-597
Author(s):  
Rebekka Pomiersky ◽  
Bastian Abel ◽  
Christian Werner ◽  
André Lacroix ◽  
Klaus Pfeiffer ◽  
...  
Keyword(s):  
Physical Activity ◽  
Intervention Program ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
The Elderly ◽  
Control Group ◽  
Moderate Dementia ◽  
Activity Questionnaire

This study investigated the effectivity and sustainability of a physical activity (PA) promotion and motor training programs and analyzed predictors for PA changes in persons with dementia. A total of 122 participants with mild-to-moderate dementia were randomized to the intervention program designed for persons with dementia (intervention group) or a motor placebo activity (control group). The primary outcome was the Physical Activity Questionnaire for the Elderly assessed at the baseline, after the 3-month intervention, and at a 3-month follow-up. The PA promotion program significantly increased PA in the intervention group compared with the control group during the training intervention phase. Both groups showed an increase in habitual PA when intervention-induced activities were excluded. PA was sustainably increased in both groups at follow-up. Low baseline PA was predictive for increased PA after the intervention and low baseline PA, high motor performance, and low comorbidity for increased PA at follow-up.

scholarly journals Web-Based Intervention Using Behavioral Activation and Physical Activity for Adults With Depression (The eMotion Study): Pilot Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Jeffrey D Lambert ◽  
Colin J Greaves ◽  
Paul Farrand ◽  
Lisa Price ◽  
Anne M Haase ◽  
...  
Keyword(s):  
Physical Activity ◽  
Data Collection ◽  
Behavioral Activation ◽  
Intervention Group ◽  
Control Group ◽  
Accelerometer Data ◽  
Web Based ◽  
Symptoms Of Depression ◽  
Secondary Outcomes

BACKGROUND Physical activity is a potentially effective treatment for depression and depressive relapse. However, promoting physical activity in people with depression is challenging. Interventions informed by theory and evidence are therefore needed to support people with depression to become more physically active. eMotion is a Web-based intervention combining behavioral activation and physical activity promotion for people in the community with symptoms of depression. OBJECTIVE The objectives were to assess the feasibility and acceptability of delivering eMotion to people in the community with symptoms of depression and to explore outcomes. METHODS Participants with elevated depressive symptoms were recruited from the community through various methods (eg, social media) and randomized to eMotion or a waiting list control group for 8 weeks. eMotion is an administratively supported weekly modular program that helps people use key behavior change techniques (eg, graded tasks, action planning, and self-monitoring) to re-engage in routine, pleasurable, and necessary activities, with a focus on physical activities. Feasibility data were collected that included the following: recruitment and trial retention rates; fidelity of intervention delivery, receipt, and enactment; and acceptability of the intervention and data collection procedures. Data were collected for the primary (depression) and secondary outcomes (eg, anxiety, physical activity, fidelity, and client satisfaction) at baseline and 2 months postrandomization using self-reported Web-based questionnaires and accelerometers. Delivery fidelity (logins, modules accessed, time spent) was tracked using Web usage statistics. Exploratory analyses were conducted on the primary and secondary outcomes. RESULTS Of the 183 people who contacted the research team, 62 were recruited and randomized. The mean baseline score was 14.6 (SD 3.2) on the 8-item Patient Health Questionnaire depression scale (PHQ-8). Of those randomized, 52 participants provided accelerometer-recorded physical activity data at baseline that showed a median of 35.8 (interquartile range [IQR] 0.0-98.6) minutes of moderate-to-vigorous physical activity (MVPA) recorded in at least 10-minute bouts per week, with only 13% (7/52) people achieving guideline levels (150 minutes of MVPA per week). In total, 81% (50/62) of participants provided follow-up data for the primary outcome (PHQ-8), but only 39% (24/62) provided follow-up accelerometer data. Within the intervention group, the median number of logins, modules accessed, and total minutes spent on eMotion was 3 (IQR 2.0-8.0), 3 (IQR 2.0-5.0), and 41.3 (IQR 18.9-90.4), respectively. Acceptability was mixed. Exploratory data analysis showed that PHQ-8 levels were lower for the intervention group than for the control group at 2 months postrandomization (adjusted mean difference −3.6, 95% CI −6.1 to −1.1). CONCLUSIONS It was feasible to deliver eMotion in UK communities to inactive populations. eMotion has the potential to be effective and is ready for testing in a full-scale trial. Further work is needed to improve engagement with both the intervention and data collection procedures. CLINICALTRIAL ClinicalTrials.gov NCT03084055; https://clinicaltrials.gov/ct2/show/NCT03084055 (Archived by WebCite at http://www.webcitation.org/6zoyM8UXa)

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.

Motivational Interviewing to Support Oral AntiCoagulation adherence in patients with non-valvular Atrial Fibrillation (MISOAC-AF): a randomised clinical trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Tzikas ◽  
A Samaras ◽  
A Kartas ◽  
D Vasdeki ◽  
G Fotos ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Medication Adherence ◽  
Medical Care ◽  
Oral Anticoagulation ◽  
Intervention Group ◽  
Control Group ◽  
Motivational Intervention ◽  
Clinical Events ◽  
Secondary Outcomes

Abstract Background Oral anticoagulation (OAC) is paramount to effective thromboprophylaxis; yet adherence to OAC remains largely suboptimal in patients with atrial fibrillation (AF). Purpose We aimed to assess the impact of an educational, motivational intervention on the adherence to OAC in patients with non-valvular AF. Methods Hospitalised patients with non-valvular AF who received OAC were randomly assigned to usual medical care or a proactive intervention, comprising motivational interviewing and tailored counseling on medication adherence. The primary study outcome was adherence to OAC at 1-year, evaluated as Proportion of Days Covered (PDC) by OAC regimens and assessed through nationwide prescription registers. Secondary outcomes included the rate of persistence to OAC, gaps in treatment, proportion of VKA-takers with labile INR (defined as time to therapeutic range&lt;70%) and clinical events. Results A total of 1009 patients were randomised, 500 in the intervention group and 509 in the control group. At 1-year follow-up, 77.2% (386/500) of patients in the intervention group had good adherence (PDC&gt;80%), compared with 55% (280/509) in the control group (adjusted odds ratio 2.84, 95% confidence interval 2.14–3.75; p&lt;0.001). Mean PDC±SD was 0.85±0.26 and 0.75±0.31, respectively (p&lt;0.001). Patients that received the intervention were more likely to persist in their OAC therapy at 1 year, while usual medical care was associated with more major (≥3 months) treatment gaps [Figure]. Among 212 VKA-takers, patients in the intervention group were less likely to have labile INR compared with those in the control group [21/120 (17.1%) vs 34/92 (37.1%), OR 0.33 95% CI 1.15–0.72, p=0.005]. Clinical events over a median follow-up period of 2 years occurred at a numerically lower, yet non-significant, rate in the intervention group [Table]. Conclusions In patients receiving OAC therapy for non-valvular AF, a motivational intervention significantly improved patterns of medication adherence, without significantly affecting clinical outcomes. Primary and secondary outcomes Funding Acknowledgement Type of funding source: None

scholarly journals Influence of physical activity on periodontal health in patients with type 2 diabetes mellitus. A blinded, randomized, controlled trial

2021 ◽  
Author(s):  
K. Wernicke ◽  
J. Grischke ◽  
M. Stiesch ◽  
S. Zeissler ◽  
K. Krüger ◽  
...  
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Periodontal Health ◽  
Randomized Controlled ◽  
Hba1c Levels

Abstract Objectives The aim was to investigate the effect of physical activity on periodontal health and HbA1c levels in patients with type 2 diabetes mellitus (T2DM) over a period of 6 months. Materials and methods Thirty-seven patients with non-insulin-dependent T2DM were included in the study. The intervention group (n=20) performed physical activity over a period of 6 months. The control group (n=17) did not receive any intervention. Baseline and final examinations included dental parameters and concentrations of glycosylated hemoglobin (HbA1c) and high-sensitivity C-reactive protein (hsCRP). Results Physical activity showed a positive effect on periodontal health. Both the BOP (p= 0.005) and the severity of periodontitis (p= 0.001) were significantly reduced in the intervention group compared to the control group. Furthermore, HbA1c levels were reduced (p= 0.010) significantly in the intervention group while hsCRP levels significantly increased in the control group (p= 0.04). Conclusions Within the limitations of this randomized, controlled trial, physical activity over a period of 6 months is a health-promoting measure for patients with T2DM and improves both periodontal health and HbA1c concentrations.

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.

Sign in / Sign up

Export Citation Format

Share Document