Dataset Information

Digital Health Coaching for Type 2 Diabetes: Randomized Controlled Trial of Healthy at Home.

ABSTRACT: Digital health coaching is an intervention for type 2 diabetes mellitus (T2DM) that has potential to improve the quality of care for patients. Previous research has established the efficacy of digital interventions for behavior change. This pilot study addresses a research gap in finding effective and accessible behavioral interventions for under-resourced individuals with T2DM. We examined the impact of Healthy at Home, a 12-week phone and SMS-based (short message service) digital health coaching program, on insulin resistance which is an upstream marker for T2DM progression. We compared this intervention to usual diabetic care in a family medicine residency clinic in a randomized controlled trial. Digital health coaching significantly improved participants' calculated Homeostatic Model Assessment for Insulin Resistance (HOMA2-IR) by -0.9 ± 0.4 compared with the control group (p = 0.029). This significance remained after controlling for years diagnosed with T2DM, enrollment in Medicaid, access to food, baseline stage of change, and race (p = 0.027). Increasing access to digital health coaching may lead to more effective control of diabetes for under-resourced patients. This study demonstrates the potential to implement a personalized, scalable, and effective digital health intervention to treat and manage T2DM through a lifestyle and behavioral approach to improve clinical outcomes (http://clinicaltrials.gov, NCT04872647).

SUBMITTER: Azelton KR

PROVIDER: S-EPMC8655126 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Digital Health Coaching for Type 2 Diabetes: Randomized Controlled Trial of Healthy at Home.

Azelton Kimberly R KR Crowley Aidan P AP Vence Nicholas N Underwood Karin K Morris Gerald G Kelly John J Landry Matthew J MJ

Frontiers in digital health 20211125

Digital health coaching is an intervention for type 2 diabetes mellitus (T2DM) that has potential to improve the quality of care for patients. Previous research has established the efficacy of digital interventions for behavior change. This pilot study addresses a research gap in finding effective and accessible behavioral interventions for under-resourced individuals with T2DM. We examined the impact of <i>Healthy at Home</i>, a 12-week phone and SMS-based (short message service) digital health ...[more]

PMID: 34901926

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Project description:BACKGROUND:Chronic diseases, including diabetes mellitus, are the leading cause of mortality and disability in the United States. Current solutions focus primarily on diagnosis and pharmacological treatment, yet there is increasing evidence that patient-centered models of care are more successful in improving and addressing chronic disease outcomes. OBJECTIVE:The objective of this clinical trial is to evaluate the impact of a mobile health (mHealth) enabled nurse health coaching intervention on self-efficacy among adults with type-2 diabetes mellitus. METHODS:A randomized controlled trial was conducted at an academic health system in Northern California. A total of 300 participants with type-2 diabetes were scheduled to be enrolled through three primary care clinics. Participants were randomized to either usual care or intervention. All participants received training on use of the health system patient portal. Participants in the intervention arm received six scheduled health-coaching telephone calls with a registered nurse and were provided with an activity tracker and mobile application that integrated data into the electronic health record (EHR) to track their daily activity and health behavior decisions. All participants completed a baseline survey and follow-up surveys at 3 and 9 months. Primary and secondary outcomes include diabetes self-efficacy, hemoglobin A1c (HbA1c), and quality of life measures. RESULTS:Data collection for this trial, funded by the Patient-Centered Outcomes Research Institute, will be completed by December 2017. Results from the trial will be available mid-2018. CONCLUSIONS:This protocol details a patient-centered intervention using nurse health coaching, mHealth technologies, and integration of patient-generated data into the EHR. The aim of the intervention is to enhance self-efficacy and health outcomes by providing participants with a mechanism to track daily activity by offering coaching support to set reasonable and attainable health goals, and by creating a complete feedback loop by bringing patient-generated data into the EHR. TRIAL REGISTRATION:ClinicalTrials.gov NCT02672176; https://clinicaltrials.gov/ct2/show/NCT02672176 (Archived by WebCite at http://www.webcitation.org/6xEQXe1M5).

Project description:BACKGROUND:Type 2 diabetes is a growing public health problem amenable to prevention and health promotion. As healthy behaviors have an impact on disease outcomes, approaches to support and sustain diabetes self-management are vital. OBJECTIVE:This study aimed to evaluate the effectiveness of a nurse coaching program using motivational interviewing paired with mobile health (mHealth) technology on diabetes self-efficacy and self-management for persons with type 2 diabetes. METHODS:This randomized controlled trial compared usual care with an intervention that entailed nurse health coaching and mHealth technology to track patient-generated health data and integrate these data into an electronic health record. The inclusion criteria were as follows: (1) enrolled at 1 of 3 primary care clinics, (2) aged 18 years or above, (3) living with type 2 diabetes, and (4) English-speaking. We collected outcome measures at baseline, 3 months, and 9 months. The primary outcome was diabetes self-efficacy; secondary outcomes were depressive symptoms, perceived stress, physical functioning, and emotional distress and anxiety. Linear regression mixed modeling estimated the population trends and individual differences in change. RESULTS:We enrolled 319 participants; 287 participants completed the study (155 control and 132 intervention). The participants in the intervention group had significant improvements in diabetes self-efficacy (Diabetes Empowerment Scale, 0.34; 95% CI -0.15,0.53; P<.01) and a decrease in depressive symptoms compared with usual care at 3 months (Patient Health Questionnaire-9; 0.89; 95% CI 0.01-1.77; P=.05), with no differences in the other outcomes. The differences in self-efficacy and depression scores between the 2 arms at 9 months were not sustained. The participants in the intervention group demonstrated a significant increase in physical activity (from 23,770 steps per week to 39,167 steps per week at 3 months and 32,601 per week at 9 months). CONCLUSIONS:We demonstrated the short-term effectiveness of this intervention; however, by 9 months, although physical activity remained above the baseline, the improvements in self-efficacy were not sustained. Further research should evaluate the minimum dose of coaching required to continue progress after active intervention and the potential of technology to provide effective ongoing automated reinforcement for behavior change. TRIAL REGISTRATION:ClinicalTrials.gov NCT02672176; https://clinicaltrials.gov/ct2/show/NCT02672176.

Project description:BackgroundFor chronic disease management, self-management strategies are essential to achieve sustained improvement.ObjectiveOur study evaluated the efficacy of health coaching and a self-management strategy-based electronic program on self-management strategies for patients with osteoporosis, chronic respiratory disease, or arthritis.DesignThree-arm randomized controlled trial, pilot study PARTICIPANTS: Fifty-four participants INTERVENTIONS: The first intervention group (n = 53) received a self-management strategy-based electronic program and 12 weeks of health coaching (20 sessions). The second intervention group received the information and communications technology (ICT) program; the control group received usual care and an educational booklet about self-management of chronic diseases.Main measuresThe primary outcome was the difference in the change of the mean of self-management strategy scores. Secondary outcomes included depression (PHQ-9), physical activity (Godin Leisure Exercise Questionnaire), and health habit maintenance (transtheoretical model) after 12 weeks in the program.Key resultsThe combination of health coaching and ICT was superior to control group (change 18.5 vs. - 2.6, adjusted difference = 24.5, p < 0.001); however, the ICT alone group was not superior to the control group (change 8.0 vs. - 2.6, adjusted difference = 8.0, p = 0.156). As a result of evaluating the change in the percentage of people with positive stage changes in the transtheoretical model of health habits, regular exercise (p = 0.008), a balanced diet (p = 0.005), helping others (p = 0.001), and living with loved ones (p = 0.038) showed significant differences. There was no significant difference in the changes in percentage of patients with depressive symptoms in comparison with control group; however, there was in comparison with control group among groups (p = 0.033). Compared to the control group, the proportion of patients who achieved an exercise amount of 12.5 MET or higher was significantly higher (p = 0.028) in the health coaching and ICT group.ConclusionsThe combination of ICT + health coaching led to improvement in self-management as well as in increasing exercise, and several healthy behaviors.Trial registrationhttps://clinicaltrials.gov/ct2/show/NCT03294057.

Project description:BACKGROUND:Diabetes distress (DD), a type of psychological distress specific to people with diabetes, is strongly associated with difficulties in performing self-care and inability to meet glycemic targets. Despite increased recognition of the need to manage DD, interventions that are both feasible and effective for reducing DD in routine care settings are not yet known. A pilot study showed that health coaching (HC) has some efficacy in addressing DD, but no adequately powered study has implemented a pragmatic research design capable of assessing the real-world effectiveness of HC in reducing DD. OBJECTIVE:The aim of this study is to describe the rationale and design of an ongoing clinical trial, Coaching and Education for Diabetes Distress trial, that seeks to assess whether HC effectively reduces DD among primary care patients with diabetes and whether HC is more effective than an educational program targeting DD. METHODS:The 2-arm randomized controlled trial is taking place at an academic family medicine practice in Houston, Texas. Both arms will receive usual care, which includes education about DD. In addition, the intervention arm will receive 8 HC sessions over a 5-month period. The primary outcome measure is reduction in DD over a 6-month period. Additional outcome measures include changes in hemoglobin A1c and self-care practices (medication-taking, dietary, and physical activity behaviors). RESULTS:As of March 2019, screening and recruitment are ongoing, and the results are expected by July 2020. CONCLUSIONS:HC is feasible in primary care and has been successfully applied to improving chronic disease self-management and outcomes. This study will provide evidence as to whether it has significant value in addressing important unmet psychological and behavioral needs of patients with diabetes. TRIAL REGISTRATION:ClinicalTrials.gov NCT03617146; https://clinicaltrials.gov/ct2/show/NCT03617146 (Archived by WebCite at http://www.webcitation.org/76Va37dbO). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/12166.

Dataset Information

Digital Health Coaching for Type 2 Diabetes: Randomized Controlled Trial of Healthy at Home.

Publications

Digital Health Coaching for Type 2 Diabetes: Randomized Controlled Trial of Healthy at Home.

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