scholarly journals Disability-Inclusive Diabetes Self-management Telehealth Program: Protocol for a Pilot and Feasibility Study (Preprint)

2021 ◽  
Author(s):  
Eric Evans ◽  
Ayse Zengul ◽  
Allyson Hall ◽  
Haiyan Qu ◽  
Amanda Willig ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Diabetes Management ◽  
Controlled Trial ◽  
People With Disabilities ◽  
Management Program ◽  
Health Coaching ◽  
Self Management ◽  
Control Group ◽  
Access To Health Services

BACKGROUND Individuals with disabilities and type 2 diabetes require self-management programs that are accessible, sustainable, inclusive, and adaptable. Health coaching has been shown to be an effective approach for improving behavioral changes in self-management. Health coaching combined with telehealth technology has the potential to improve the overall quality of and access to health services. OBJECTIVE This protocol outlines the study design for implementing the Artificial Intelligence for Diabetes Management (AI4DM) intervention. The protocol will assess the feasibility, acceptability, and preliminary efficacy of the AI4DM telehealth platform for people with disabilities. METHODS The AI4DM study is a 2-arm randomized controlled trial for evaluating the delivery of a 12-month intervention, which will involve telecoaching, diabetes educational content, and technology access, to 90 individuals with diabetes and physical disabilities. The hypothesis is that this pilot project is feasible and acceptable for adults with permanently impaired mobility and type 2 diabetes. We also hypothesize that adults in the AI4DM intervention groups will have significantly better glycemic control (glycated hemoglobin) and psychosocial and psychological measures than the attention control group at the 3-, 6-, and 12-month follow-ups. RESULTS The AI4DM study was approved by the university’s institutional review board, and recruitment and enrollment will begin in October 2021. CONCLUSIONS The AI4DM study will improve our understanding of the feasibility and efficacy of a web-based diabetes self-management program for people with disabilities. The AI4DM intervention has the potential to become a scalable and novel method for successfully managing type 2 diabetes in people with disabilities. CLINICALTRIAL ClinicalTrials.gov NCT04927377; https://clinicaltrials.gov/ct2/show/NCT04927377 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/31689

scholarly journals Disability-Inclusive Diabetes Self-management Telehealth Program: Protocol for a Pilot and Feasibility Study

10.2196/31689 ◽  
2021 ◽  
Vol 10 (9) ◽  
pp. e31689 ◽  
Author(s):  
Eric Evans ◽  
Ayse Zengul ◽  
Allyson Hall ◽  
Haiyan Qu ◽  
Amanda Willig ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Diabetes Management ◽  
Controlled Trial ◽  
People With Disabilities ◽  
Management Program ◽  
Health Coaching ◽  
Self Management ◽  
Control Group ◽  
Access To Health Services

Background Individuals with disabilities and type 2 diabetes require self-management programs that are accessible, sustainable, inclusive, and adaptable. Health coaching has been shown to be an effective approach for improving behavioral changes in self-management. Health coaching combined with telehealth technology has the potential to improve the overall quality of and access to health services. Objective This protocol outlines the study design for implementing the Artificial Intelligence for Diabetes Management (AI4DM) intervention. The protocol will assess the feasibility, acceptability, and preliminary efficacy of the AI4DM telehealth platform for people with disabilities. Methods The AI4DM study is a 2-arm randomized controlled trial for evaluating the delivery of a 12-month intervention, which will involve telecoaching, diabetes educational content, and technology access, to 90 individuals with diabetes and physical disabilities. The hypothesis is that this pilot project is feasible and acceptable for adults with permanently impaired mobility and type 2 diabetes. We also hypothesize that adults in the AI4DM intervention groups will have significantly better glycemic control (glycated hemoglobin) and psychosocial and psychological measures than the attention control group at the 3-, 6-, and 12-month follow-ups. Results The AI4DM study was approved by the university’s institutional review board, and recruitment and enrollment will begin in October 2021. Conclusions The AI4DM study will improve our understanding of the feasibility and efficacy of a web-based diabetes self-management program for people with disabilities. The AI4DM intervention has the potential to become a scalable and novel method for successfully managing type 2 diabetes in people with disabilities. Trial Registration ClinicalTrials.gov NCT04927377; https://clinicaltrials.gov/ct2/show/NCT04927377 International Registered Report Identifier (IRRID) PRR1-10.2196/31689

scholarly journals Development and Evaluation of a Computer-Based, Self-Management Tool for People Recently Diagnosed with Type 2 Diabetes

2016 ◽  
Vol 2016 ◽  
pp. 1-11 ◽  
Author(s):  
Alison O. Booth ◽  
Carole Lowis ◽  
Steven J. Hunter ◽  
Moira Dean ◽  
Chris R. Cardwell ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Computer Program ◽  
User Satisfaction ◽  
Controlled Trial ◽  
Intervention Group ◽  
Management Tool ◽  
Self Management ◽  
Control Group ◽  
Computer Based

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.

scholarly journals Effects of a mobile health diabetes self-management program on HbA1C, self-management and patient satisfaction in adults with uncontrolled type 2 diabetes: a randomized controlled trial

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Chontira Riangkam ◽  
Aurawamon Sriyuktasuth ◽  
Kanaungnit Pongthavornkamol ◽  
Worapan Kusakunniran ◽  
Apiradee Sriwijitkamol
Keyword(s):  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Patient Satisfaction ◽  
Mobile Health ◽  
Controlled Trial ◽  
Management Program ◽  
Self Management ◽  
Content Type ◽  
Randomized Controlled

PurposeThis study aimed to examine the effects of a three-month mobile health diabetes self-management program (MHDSMP) on glycemic control, diabetes self-management (DSM) behaviors and patient satisfaction in adults with uncontrolled type 2 diabetes (T2DM) in Thailand.Design/methodology/approachThis was a three-arm, parallel-group, randomized controlled trial among 129 adults with uncontrolled T2DM who attended the medical outpatient department in a medical center. The participants were randomly assigned to the three study groups (n = 43 per group), including MHDSMP, telephone follow-up (TF) and usual care (UC). MHDSMP encompassed four components, including DSM engagement, DSM mobile application, motivational text messages and telephone coaching. Outcomes were evaluated at three-month end-of-study by using HbA1C and response to the Summary of Diabetes Self-Care Activities (SDSCA) and the Client Satisfaction Questionnaire (CSQ-8). Data were analyzed by using descriptive statistics and multivariate analysis of covariance (MANCOVA).FindingsThe findings revealed that at the end-of-study, HbA1C decreased from 7.80 to 7.17% (p < 0.001) in MHDSMP group, from 7.72 to 7.65% (p = 0.468) in TF group, and from 7.89 to 7.72% (p = 0.074) in UC group. Significantly higher SDSCA and CSQ-8 scores were also observed in MHDSMP compared to TF and UC groups (F = 12.283, F = 19.541, F = 8.552, p < 0.001, respectively).Originality/valueThis study demonstrated that MHDSMP adjunct with usual care is beneficial for patient outcomes in adults with uncontrolled T2DM in Thailand, compared to TF and UC groups.

scholarly journals Managing with Learning Disability and Diabetes: OK-Diabetes – a case-finding study and feasibility randomised controlled trial

2018 ◽  
Vol 22 (26) ◽  
pp. 1-328 ◽  
Author(s):  
Allan House ◽  
Louise Bryant ◽  
Amy M Russell ◽  
Alexandra Wright-Hughes ◽  
Liz Graham ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Observational Study ◽  
Learning Disability ◽  
Diabetes Management ◽  
Controlled Trial ◽  
Self Management ◽  
Feasibility Randomised Controlled Trial ◽  
The Mean ◽  
Randomised Controlled

BackgroundObesity and type 2 diabetes are common in adults with a learning disability. It is not known if the principles of self-management can be applied in this population.ObjectivesTo develop and evaluate a case-finding method and undertake an observational study of adults with a learning disability and type 2 diabetes, to develop a standardised supported self-management (SSM) intervention and measure of adherence and to undertake a feasibility randomised controlled trial (RCT) of SSM versus treatment as usual (TAU).DesignObservational study and an individually randomised feasibility RCT.SettingThree cities in West Yorkshire, UK.ParticipantsIn the observational study: adults aged > 18 years with a mild or moderate learning disability, who have type 2 diabetes that is not being treated with insulin and who are living in the community. Participants had mental capacity to consent to research and to the intervention. In the RCT participants had glycated haemoglobin (HbA1c) levels of > 6.5% (48 mmol/mol), a body mass index (BMI) of > 25 kg/m2or self-reported physical activity below national guideline levels.InterventionsStandardised SSM. TAU supported by an easy-read booklet.Main outcome measures(1) The number of eligible participants identified and sources of referral; (2) current living and support arrangements; (3) current health state, including level of HbA1c, BMI and waist circumference, blood pressure and lipids; (4) mood, preferences for change; (5) recruitment and retention in RCT; (6) implementation and adherence to the intervention; (7) completeness of data collection and values for candidate primary outcomes; and (8) qualitative data on participant experience of the research process and intervention.ResultsIn the observational study we identified 147 eligible consenting participants. The mean age was 54.4 years. In total, 130 out of 147 (88%) named a key supporter, with 113 supporters (77%) being involved in diabetes management. The mean HbA1clevel was 54.5 mmol/mol [standard deviation (SD) 14.8 mmol/mol; 7.1%, SD 1.4%]. The BMI of 65% of participants was > 30 kg/m2and of 21% was > 40 kg/m2. Many participants reported low mood, dissatisfaction with lifestyle and diabetes management and an interest in change. Non-response rates were high (45/147, 31%) for medical data requested from the primary care team. In the RCT, 82 participants were randomised. The mean baseline HbA1clevel was 56 mmol/mol (SD 16.5 mmol/mol; 7.3%, SD 1.5%) and the mean BMI was 34 kg/m2(SD 7.6 kg/m2). All SSM sessions were completed by 35 out of 41 participants. The adherence measure was obtained in 37 out of 41 participants. The follow-up HbA1clevel and BMI was obtained for 75 out of 82 (91%) and 77 out of 82 (94%) participants, respectively. Most participants reported a positive experience of the intervention. A low response rate and difficulty understanding the EuroQol-5 Dimensions were challenges in obtaining data for an economic analysis.LimitationsWe recruited from only 60% of eligible general practices, and 90% of participants were on a general practice learning disability register, which meant that we did not recruit many participants from the wider population with milder learning disability.ConclusionsA definitive RCT is feasible and would need to recruit 194 participants per arm. The main barrier is the resource-intensive nature of recruitment. Future research is needed into the effectiveness of obesity treatments in this population, particularly estimating the longer-term outcomes that are important for health benefit. Research is also needed into improving ways of assessing quality of life in adults with a learning disability.Trial registrationCurrent Controlled Trials ISRCTN41897033.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 26. See the NIHR Journals Library website for further project information.

scholarly journals Effectiveness of a clinic-based randomized controlled intervention for type 2 diabetes management: an innovative model of intensified diabetes management in Mainland China (C-IDM study)

2020 ◽  
Vol 8 (1) ◽  
pp. e001030 ◽  
Author(s):  
Qinglin Lou ◽  
Qing Ye ◽  
Haidi Wu ◽  
Zhiyong Wang ◽  
Robert S Ware ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Large Scale ◽  
Diabetes Management ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mainland China ◽  
Outcome Variable ◽  
Control Group ◽  
Randomized Controlled

ObjectivesHighly efficient diabetes management programs are needed for tackling diabetes in China. This study aimed to assess the effectiveness of a clinic-based intensified diabetes management model (C-IDM) in Mainland China.Research design and methodsA 2-year clinic-based randomized controlled trial was conducted among patients with type 2 diabetes in Nanjing, China. The C-IDM intervention components comprised four domains (disease targeting management, express referral channel, expert visit, patients’ self-management) and an integrated running system (disease control centers, general hospitals and local clinics). Control group participants received their usual care, while intervention participants received both the C-IDM package and the usual services. The primary outcome variable was change of hemoglobin A1c (HbA1c). Mixed-effects models were used to compute effect estimates and 95% CI with consideration of both individual and cluster-level confounders.ResultsOverall, 1095 of 1143 participants were assessed at study completion. The mean change in HbA1c was significantly greater in the intervention group than in the control group (mean difference (MD)=−0.57, 95% CI −0.79 to –0.36). Similar results were observed for change in body mass index (MD=−0.29, 95% CI −0.49 to –0.10). Participants in the intervention group were more likely to achieve normal HbA1c and body weight compared with their counterparts in control group after adjusting for potentially confounding variables (adjusted OR=1.94, 95% CI 1.35 to 2.81 and 1.79, 95% CI 1.13 to 2.85, respectively).ConclusionsThe C-IDM model is feasible and effective in large-scale management of patients with type 2 diabetes in China. It has public health implications for tackling the burden of diabetes in China.Trial registration numberChiCTR-IOR-15006019.

scholarly journals Effectiveness of the Beyond Good Intentions Program on Improving Dietary Quality Among People With Type 2 Diabetes Mellitus: A Randomized Controlled Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Laura A. van der Velde ◽  
Jessica C. Kiefte-de Jong ◽  
Guy E. Rutten ◽  
Rimke C. Vos
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Dietary Quality ◽  
Self Management ◽  
Control Group ◽  
Randomized Controlled

Background and Aims: An appropriate diet is an essential component of the management of Type 2 Diabetes Mellitus (T2DM). However, for many people with T2DM, self-management is difficult. Therefore, the Beyond Good Intentions (BGI) education program was developed based on self-regulation and proactive coping theories to enhance people's capabilities for self-management. The aim of this study was to determine the effectiveness of the BGI program on improving dietary quality among a preselected group of people with T2DM after two-and-a-half years follow-up.Methods: In this randomized controlled trial, 108 people with T2DM were randomized (1:1) to the intervention (n = 56) (BGI-program) or control group (n = 52) (care as usual). Linear regression analyses were used to determine the effect of the BGI program on change in dietary quality between baseline and two-and-a-half years follow-up. In addition, potential effect modification by having a nutritional goal at baseline was evaluated. Multiple imputation (n = 15 imputations) was performed to account for potential bias due to missing data.Results: According to intention-to-treat analysis, participants in the intervention group showed greater improvements in dietary quality score than participants in the control group (β = 0.71; 95%CI: 0.09; 1.33) after follow-up. Having a nutritional goal at baseline had a moderating effect on the effectiveness of the BGI program on dietary quality (p-interaction = 0.01), and stratified results showed that the favorable effect of the intervention on dietary quality was stronger for participants without a nutritional goal at baseline (no nutritional goal: β = 1.46; 95%CI: 0.65; 2.27 vs. nutritional goal: β = −0.24; 95%CI: −1.17; 0.69).Conclusions: The BGI program was significantly effective in improving dietary quality among preselected people with T2DM compared to care as usual. This effect was stronger among participants without a nutritional goal at baseline. A possible explanation for this finding is that persons with a nutritional goal at baseline already started improving their dietary intake before the start of the BGI program. Future studies are needed to elucidate the moderating role of goalsetting on the effectiveness of the BGI program.

A Feasibility Study of a Culturally Tailored Diabetes Intervention for Mexican Americans

2007 ◽  
Vol 9 (2) ◽  
pp. 130-141 ◽  
Author(s):  
Deborah Vincent ◽  
Alice Pasvogel ◽  
Lourdes Barrera
Keyword(s):  
Type 2 Diabetes ◽  
Body Mass Index ◽  
Mexican Americans ◽  
Management Program ◽  
Retention Rates ◽  
Self Management ◽  
Control Group ◽  
Diabetes Knowledge ◽  
Culturally Tailored

Latinos, the fastest growing minority group in the United States, are among the hardest hit by diabetes. Among Latinos, Mexican Americans have the highest rate (23.9%) of diabetes. Good self-management can improve glycemic control and decrease diabetes complications but can be challenging to achieve. The purpose of this study was to test the feasibility and examine the effects of a culturally tailored intervention for Mexican Americans with type 2 diabetes on outcomes of self-management. The study used a pretest/posttest control group design with 10 participants in each group ( N = 17). Feasibility and acceptability of the tailored diabetes self-management program was assessed by examining ease of recruitment and retention rates. The behavioral outcomes of self-efficacy, diabetes knowledge and self-care measures, and the biologic outcomes of weight, body mass index, HbA1C, and blood glucose were used to examine intervention effectiveness. Successful recruitment of participants came from personal referrals from providers or the promotora. Retention rates were 100% for the intervention group and 80% for the control group. Findings suggest that the intervention had a positive clinical and statistical effect on diabetes knowledge, weight, and body mass index. Improvements were also noted in self-efficacy scores, blood glucose, and HbA1C, but these changes did not reach statistical significance. A culturally tailored diabetes self-management program may result in improved outcomes for Mexican Americans with type 2 diabetes.

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.

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