scholarly journals A pragmatic randomised controlled trial referring to a Personalised Self-management SUPport Programme (P-SUP) for persons enrolled in a disease management programme for type 2 diabetes mellitus and/or for coronary heart disease

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Uwe Konerding ◽  
Marcus Redaèlli ◽  
Karolin Ackermann ◽  
Sibel Altin ◽  
Sebastian Appelbaum ◽  
...  

Abstract Background Type 2 diabetes mellitus (T2DM) and coronary heart disease (CHD) are two chronic diseases that cause a tremendous burden. To reduce this burden, several programmes for optimising the care for these diseases have been developed. In Germany, so-called disease management programmes (DMPs), which combine components of Disease Management and the Chronic Care Model, are applied. These DMPs have proven effective. Nevertheless, there are opportunities for improvement. Current DMPs rarely address self-management of the disease, make no use of peer support, and provide no special assistance for persons with low health literacy and/or low patient activation. The study protocol presented here is for the evaluation of a programme that addresses these possible shortcomings and can be combined with current German DMPs for T2DM and CHD. This programme consists of four components: Meetings of peer support groups Personalised telephone-based health coaching for patients with low literacy and/or low patient activation Personalised patient feedback A browser-based web portal Methods Study participants will be adults enrolled in a DMP for T2DM and/or CHD and living in North Rhine-Westphalia, a state of the Federal Republic of Germany. Study participants will be recruited with the assistance of their general practitioners by the end of June 2021. Evaluation will be performed as a pragmatic randomised controlled trial with one intervention group and one waiting control group. The intervention group will receive the intervention for 18 months. During this time, the waiting control group will continue with usual care and the usual measures of their DMPs. After 18 months, the waiting control group will also receive a shortened intervention. The primary outcome is number of hospital days. In addition, the effects on self-reported health-state, physical activity, nutrition, and eight different psychological variables will be investigated. Differences between values at month 18 and at the beginning will be compared to judge the effectiveness of the intervention. Discussion If the intervention proves effective, it may be included into the DMPs for T2DM and CHD. Trial registration The study was registered in the German Clinical Trials Registry (Deutsches Register Klinischer Studien (DRKS)) in early 2019 under the number 00020592. This registry has been affiliated with the WHO Clinical Trials Network (https://www.drks.de/drks_web/setLocale_EN.do) since 2008. It is based on the WHO template, but contains some additional categories for which information has to be given (https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields ). A release and subsequent number assignment only take place when information for all categories has been given.

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e023017 ◽  
Author(s):  
Torunn Hatlen Nøst ◽  
Aslak Steinsbekk ◽  
Ola Bratås ◽  
Kjersti Grønning

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.


2016 ◽  
Vol 2016 ◽  
pp. 1-11 ◽  
Author(s):  
Alison O. Booth ◽  
Carole Lowis ◽  
Steven J. Hunter ◽  
Moira Dean ◽  
Chris R. Cardwell ◽  
...  

Aim. The purpose of this study was to develop and evaluate a computer-based, dietary, and physical activity self-management program for people recently diagnosed with type 2 diabetes.Methods. The computer-based program was developed in conjunction with the target group and evaluated in a 12-week randomised controlled trial (RCT). Participants were randomised to the intervention (computer-program) or control group (usual care). Primary outcomes were diabetes knowledge and goal setting (ADKnowl questionnaire, Diabetes Obstacles Questionnaire (DOQ)) measured at baseline and week 12. User feedback on the program was obtained via a questionnaire and focus groups.Results. Seventy participants completed the 12-week RCT (32 intervention, 38 control, mean age 59 (SD) years). After completion there was a significant between-group difference in the “knowledge and beliefs scale” of the DOQ. Two-thirds of the intervention group rated the program as either good or very good, 92% would recommend the program to others, and 96% agreed that the information within the program was clear and easy to understand.Conclusions. The computer-program resulted in a small but statistically significant improvement in diet-related knowledge and user satisfaction was high. With some further development, this computer-based educational tool may be a useful adjunct to diabetes self-management. This trial is registered with clinicaltrials.gov NCT numberNCT00877851.


BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e034655
Author(s):  
Andy S K Cheng ◽  
Xiangyu Liu ◽  
Peter H F Ng ◽  
Cindy T T Kwok ◽  
Yingchun Zeng ◽  
...  

IntroductionThe eHealth technologies that are being designed for chronic disease constitute a global trend towards health assessment and self-management. However, most of these approaches tend to focus on a single symptom or problem rather than on the multiple problems that are characteristic of many of these chronic illnesses. The aim of this study is to examine the effectiveness of and adherence to a self-management application (app) that identifies multiple problem areas related to surviving breast cancer as the targeted chronic illness.Methods and analysisThis is a randomised controlled study. Eligible participants will be allocated randomly into either an intervention group or a control group at a 1:1 ratio. The intervention group will be assigned to the self-management app (‘Be-with-You’), while the control group will use a general health app (‘Sham’ app). The primary outcomes will include the differences between the two groups in their health literacy, problem-solving skills and self-management skills. The secondary outcomes will include group differences in self-efficacy, readiness for change and health-related quality of life. All of these outcomes will be measured at baseline and at 4 weeks and 12 weeks after intervention. In addition, usability of these two mobile apps will be measured at 4 weeks and 12 weeks after intervention. The planned sample size is 476.Ethics and disseminationThe Human Subjects Ethics Sub-committee of The Hong Kong Polytechnic University approved the study (HSEARS20190922001, 24 September 2019). Dissemination of findings will occur at the local, national and international levels.Trial registration numberChiCTR1900026244.


2019 ◽  
Author(s):  
Joe Brew ◽  
Margaret Pinder ◽  
Umberto Dalessandro ◽  
Steven W Lindsay ◽  
Carloine Jones ◽  
...  

Abstract Background Recording behaviours that have the potential to impact health can be doubly challenging if the behaviour takes place in private spaces that cannot be observed directly and where there is potential for social desirability bias, i.e. where the respondent may give an answer that they think the recorder wants to hear. Sleeping under a long-lasting insecticidal net (LLIN) is an important intervention for malaria prevention, yet it is difficult to gauge the extent to which coverage (how many nets are in the community) differs from usage (how many people sleep under a net). We employed a novel method, list randomization, which partially obscures respondents' answers to sensitive questions, as a mean to provide an accurate estimate of LLIN usage in The Gambia.Methods We surveyed 196 residents from 196 households recruited into a randomised controlled trial assessing the effect of a housing intervention on malaria. In the current experiment, 98 of the 196 study participants were randomly assigned to the control group and received a four-question list about non-sensitive behaviours; the other participants in the intervention group, received the same list, with the addition of one question on a sensitive behaviour; whether or not they had used a bednet the previous night. Participants were read the list of questions and then said how many of the statements were true. We estimated bednet usage by calculating the difference in means between the total number of affirmative items between the two groups, and quantified uncertainty using a t-test.Results The mean number of affirmative responses in the control group was 2.60 of four statements (95% confidence interval, 95% CI, = 2.50-2.70), compared with 3.68 (95% CI = 3.59-3.78) in the intervention group. Such difference (1.08; 95% CI = 94.9-100%) suggests approximately 100% bednet usage.Conclusions Our findings suggest complete universal bednet usage in the study area. Further validation of the list randomization method in areas with lower net coverage is required.


2020 ◽  
Author(s):  
Ronald W Gimbel ◽  
Lior M Rennert ◽  
Paul Crawford ◽  
Jeanette R Little ◽  
Khoa Truong ◽  
...  

BACKGROUND Past mobile health (mHealth) efforts to empower type 2 diabetes (T2D) self-management include portals, text messaging, collection of biometric data, electronic coaching, email, and collection of lifestyle information. OBJECTIVE The primary objective was to enhance patient activation and self-management of T2D using the US Department of Defense’s Mobile Health Care Environment (MHCE) in a patient-centered medical home setting. METHODS A multisite study, including a user-centered design and a controlled trial, was conducted within the US Military Health System. Phase I assessed preferences regarding the enhancement of the enabling technology. Phase II was a single-blinded 12-month feasibility study that randomly assigned 240 patients to either the intervention (n=123, received mHealth technology and behavioral messages tailored to Patient Activation Measure [PAM] level at baseline) or the control group (n=117, received equipment but not messaging. The primary outcome measure was PAM scores. Secondary outcome measures included Summary of Diabetes Self-Care Activities (SDSCA) scores and cardiometabolic outcomes. We used generalized estimating equations to estimate changes in outcomes. RESULTS The final sample consisted of 229 patients. Participants were 61.6% (141/229) male, had a mean age of 62.9 years, mean glycated hemoglobin (HbA<sub>1c</sub>) of 7.5%, mean BMI of 32.7, and a mean duration of T2D diagnosis of 9.8 years. At month 12, the control group showed significantly greater improvements compared with the intervention group in PAM scores (control mean 7.49, intervention mean 1.77; <i>P</i>=.007), HbA<sub>1c</sub> (control mean −0.53, intervention mean −0.11; <i>P</i>=.006), and low-density lipoprotein cholesterol (control mean −7.14, intervention mean 4.38; <i>P</i>=.01). Both groups showed significant improvement in SDSCA, BMI, waist size, and diastolic blood pressure; between-group differences were not statistically significant. Except for patients with the highest level of activation (PAM level 4), intervention group patients exhibited significant improvements in PAM scores. For patients with the lowest level of activation (PAM level 1), the intervention group showed significantly greater improvement compared with the control group in HbA<sub>1c</sub> (control mean −0.09, intervention mean −0.52; <i>P</i>=.04), BMI (control mean 0.58, intervention mean −1.22; <i>P</i>=.01), and high-density lipoprotein cholesterol levels (control mean −4.86, intervention mean 3.56; <i>P</i>&lt;.001). Significant improvements were seen in AM scores, SDSCA, and waist size for both groups and in diastolic and systolic blood pressure for the control group; the between-group differences were not statistically significant. The percentage of participants who were engaged with MHCE for ≥50% of days period was 60.7% (68/112; months 0-3), 57.4% (62/108; months 3-6), 49.5% (51/103; months 6-9), and 43% (42/98; months 9-12). CONCLUSIONS Our study produced mixed results with improvement in PAM scores and outcomes in both the intervention and control groups. Structural design issues may have hampered the influence of tailored behavioral messaging within the intervention group. CLINICALTRIAL ClinicalTrials.gov NCT02949037; https://clinicaltrials.gov/ct2/show/NCT02949037 INTERNATIONAL REGISTERED REPORT RR2-10.2196/resprot.6993


2021 ◽  
Author(s):  
Potjana Poonprapai ◽  
Sanguan Lerkiatbundit ◽  
Woranuch - Saengcharoen

Abstract Background Family support is crucial in the care of elderly patients with diabetes. Pharmacists have proven to play an important role in assisting patients to achieve goals of drug therapy. However, more information is needed to evaluate the potential benefits of family-based intervention through a mobile application by pharmacists in the elderly diabetes patients.Objective To evaluate the influences of family support-based intervention using a mobile application on glycaemic control and diabetes control-related outcomes in the older adults with diabetes. Setting A hospital in the south of Thailand.Method A randomised controlled trial was conducted with 9 months of follow-up. Family members in the intervention group (n = 78) received diabetes educational courses and encouragement via a mobile application from pharmacists to help their elderly relatives with diabetes in self-management tasks. The control group received usual care (n = 79). Main outcome measure Glycosylated haemoglobin (HbA1c).Results As compared to baseline, significant improvements were observed in the intervention patients for HbA1c, blood pressure, family behaviour in diabetes care, diabetes knowledge, self-management practices and medication adherence (P < 0.001). The intervention group showed greater decline in HbA1c levels relative to the control group (-0.97% vs. -0.12%; P = 0.001). Significant differences between groups for changes in blood pressure levels including scores of family behaviour, diabetes knowledge, self-management and medication adherence were found (P < 0.001), with the intervention group showing greater improvement. Conclusion Family support intervention via a mobile application by pharmacists is beneficial to diabetes care for the elderly. Trial registration number: TCTR20200615001 (date 13 June 2020, retrospectively registered).


2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Atthayaporn Choomai ◽  
Apichai Wattanapisit ◽  
Orathai Tiangtam

AbstractIntroduction. Insulin injection refusal is a challenge when initiating insulin therapy. This study aimed to investigate the effects of an actual insulin injection demonstration on insulin acceptance in patients with type 2 diabetes mellitus (T2DM).Methods. A pragmatic randomised controlled trial (RCT) was conducted. The participants were patients with T2DM aged 18–65 years old. The control group (CG) received an educational programme regarding T2DM. The intervention group (IG) received the educational programme and actual insulin injection demonstration (a physician-led sample insulin injection using an insulin pen). The main outcome was immediate insulin acceptance. Insulin adherence, glycated haemoglobin (HbA1c), and adverse effects of insulin were evaluated at three months after the intervention.Results. Forty-nine participants with T2DM were allocated to the IG (n=24) and the CG (n=25). The immediate insulin acceptance was significantly higher in the IG (79.17%, n=19) than the CG (24.00%, n=6; p---lt---0.05; RR 3.30, 95%CI 1.59 to 6.82). At the three-month follow-up, the insulin adherence was significantly different between the two groups (IG: 75.00%, n=18 vs CG: 20.00%, n=5; p---lt---0.05; RR 3.75, 95%CI 1.66 to 8.49). Adverse effects of insulin, HbA1c levels, and changes in HbA1c levels between the IG and CG were not different.Conclusion. The physician-led actual insulin injection demonstration is effective for increasing insulin acceptance among participants with T2DM.


2012 ◽  
Vol 109 (3) ◽  
pp. 529-538 ◽  
Author(s):  
Victoria Telle-Hjellset ◽  
Marte K. Råberg Kjøllesdal ◽  
Benedikte Bjørge ◽  
Gerd Holmboe-Ottesen ◽  
Margareta Wandel ◽  
...  

The objective of the present study was to explore whether a culturally adapted lifestyle education programme would improve the risk factor profile for type 2 diabetes (T2D) and the metabolic syndrome (MetS) among Pakistani immigrant women in Oslo, Norway. The randomised controlled trial (the InnvaDiab study), lasting 7 ± 1 months, comprised six educational sessions about blood glucose, physical activity and diet. Participants (age 25–62 years) were randomised into either a control (n 97) or an intervention (n 101) group. Primary outcome variables were fasting and 2 h blood glucose, and secondary outcome variables were fasting levels of insulin, C-peptide, lipids, glycated Hb, BMI, waist circumference and blood pressure, measured 1–3 weeks before and after the intervention. During the intervention period, the mean fasting blood glucose decreased by 0·16 (95 % CI − 0·27, − 0·05) mmol/l in the intervention group, and remained unchanged in the control group (difference between the groups, P= 0·022). Glucose concentration 2 h after the oral glucose tolerance test decreased by 0·53 (95 % CI − 0·84, − 0·21) mmol/l in the intervention group, but not significantly more than in the control group. A larger reduction in fasting insulin was observed in the intervention group than in the control group (between-group difference, P= 0·036). Among the individuals who attended four or more of the educational sessions (n 59), we found a more pronounced decrease in serum TAG ( − 0·1 (95 % CI − 0·24, 0·07) mmol/l) and BMI ( − 0·48 (95 % CI − 0·78, − 0·18) kg/m2) compared with the control group. During the intervention period, there was a significant increase in participants having the MetS in the control group (from 41 to 57 %), which was not seen in the intervention group (from 44 to 42 %). Participation in a culturally adapted education programme may improve risk factors for T2D and prevent the development of the MetS in Pakistani immigrant women.


BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e024551 ◽  
Author(s):  
Jaimon T Kelly ◽  
Molly M Warner ◽  
Marguerite Conley ◽  
Dianne P Reidlinger ◽  
Tammy Hoffmann ◽  
...  

ObjectiveTo evaluate the feasibility and acceptability of a personalised telehealth intervention to support dietary self-management in adults with stage 3–4 chronic kidney disease (CKD).DesignMixed-methods process evaluation embedded in a randomised controlled trial.ParticipantsPeople with stage 3–4 CKD (estimated glomerular filtration rate [eGFR]15–60 mL/min/1.73 m2).SettingParticipants were recruited from three hospitals in Australia and completed the intervention in ambulatory community settings.InterventionThe intervention group received one telephone call per fortnight and 2–8 tailored text messages for 3 months, and then 4–12 tailored text messages for 3 months without telephone calls. The control group received usual care for 3 months then non-tailored education-only text messages for 3 months.Main outcome measuresFeasibility (recruitment, non-participation and retention rates, intervention fidelity and participant adherence) and acceptability (questionnaire and semistructured interviews).Statistical analyses performedDescriptive statistics and qualitative content analysis.ResultsOverall, 80/230 (35%) eligible patients who were approached consented to participate (mean±SD age 61.5±12.6 years). Retention was 93% and 98% in the intervention and control groups, respectively, and 96% of all planned intervention calls were completed. All participants in the intervention arm identified the tailored text messages as useful in supporting dietary self-management. In the control group, 27 (69%) reported the non-tailored text messages were useful in supporting change. Intervention group participants reported that the telehealth programme delivery methods were practical and able to be integrated into their lifestyle. Participants viewed the intervention as an acceptable, personalised alternative to face-face clinic consultations, and were satisfied with the frequency of contact.ConclusionsThis telehealth-delivered dietary coaching programme is an acceptable intervention which appears feasible for supporting dietary self-management in stage 3–4 CKD. A larger-scale randomised controlled trial is needed to evaluate the efficacy of the coaching programme on clinical and patient-reported outcomes.Trial registration numberACTRN12616001212448; Results.


2020 ◽  
Vol 46 (5) ◽  
pp. 455-464
Author(s):  
Ernest Asante ◽  
Victoria Bam ◽  
Abigail Kusi-Amponsah Diji ◽  
Alberta Yemotsoo Lomotey ◽  
Agnes Owusu Boateng ◽  
...  

Purpose The purpose of the study was to evaluate the feasibility and effectiveness of a nurse-led mobile phone call intervention on glycemic management and adherence to self-management practices among patients with type 2 diabetes mellitus (T2DM) in Ghana. Methods This was a pilot randomized controlled trial to compare diabetes care as usual to a mobile phone call intervention delivered by nurses in addition to care as usual over a 12-week period in a tertiary referral hospital in Ghana. Sixty patients with T2DM were randomized to either the intervention or the control arm. The intervention group received up to 16 mobile phone calls (mean duration = 12 minutes) from a diabetes specialist nurse in addition to their care as usual. The control group received only care as usual. The primary outcome was the change in A1C over the 12-week period. The secondary outcomes were changes in self-reported adherence to medication and diabetes self-management measures over the 12-week period. Results Mean baseline A1C was comparable between the intervention and control groups (9.54%, SD = 2.00% vs 9.07%, SD = 1.72%, P = .334). After 12 weeks, A1C was significantly lower in the intervention group compared to the control group. The difference in mean A1C in the control group rose by +0.26 ± 1.30% ( P = .282; 95% CI, −0.23 to 0.75), whereas that of the intervention group reduced by −1.51 ± 2.67% ( P = .004; 95% CI, −2.51 to −0.51). No improvements in self-management were recorded in the control group. In the intervention group, however, the only significant improvement was recorded in the area of foot care practices. Participant recruitment and retention were 100% without any attrition. About 87% (n = 26) of the intervention group completed at least 70% (≥11) of the calls. At the end of the trial, participants who received the intervention rated their satisfaction as 89.3% on average. Conclusion A mobile phone follow-up call by nurses emphasizing adherence to self-management practices is feasible and can improve short- to medium-term glycemic management among patients with T2DM.


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