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Study protocol: The Technology-Enhanced Coaching (TEC) program to improve diabetes outcomes - A randomized controlled trial.

ABSTRACT: Background:Racial and ethnic minority adults with diabetes living in under-resourced communities face multiple barriers to sustaining self-management behaviors necessary to improve diabetes outcomes. Peer support and decision support tools each have been associated with improved diabetes outcomes. Methods:290 primarily African American adults with poor glycemic control were recruited from the Detroit Veteran's Administration Hospital and randomized to Technology-Enhanced Coaching (TEC) or Peer Coaching alone. Participants in both arms were assigned a peer coach trained in autonomy-supportive approaches. Coaches are diabetes patients with prior poor glycemic control who now have good control. Participants met face-to-face initially with their coach to review diabetes education materials and develop an action plan. Educational materials in the TEC arm are delivered via a web-based, educational tool tailored with each participant's personalized health data (iDecide). Over six months, coaches call their assigned participants once a week to provide support for weekly action steps. Data are also collected on an Observational Control group with no contact with study staff. Changes in A1c, blood pressure, other patient-centered outcomes and mediators and moderators of intervention effects will be assessed. Results:290 participants were enrolled. Discussion:Tailored e-Health tools with educational content may enhance the effectiveness of peer coaching programs to better prepare patients to set self-management goals, identify action plans, and discuss treatment options with their health care providers. The study will provide insights for scalable self-management support programs for diabetes and chronic illnesses that require high levels of sustained patient self-management.

SUBMITTER: Heisler M

PROVIDER: S-EPMC5510884 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Study protocol: The Technology-Enhanced Coaching (TEC) program to improve diabetes outcomes - A randomized controlled trial.

Heisler Michele M Mase Rebecca R Brown Brianne B Wilson Shayla S Reeves Pamela J PJ

Contemporary clinical trials 20170127

<h4>Background</h4>Racial and ethnic minority adults with diabetes living in under-resourced communities face multiple barriers to sustaining self-management behaviors necessary to improve diabetes outcomes. Peer support and decision support tools each have been associated with improved diabetes outcomes.<h4>Methods</h4>290 primarily African American adults with poor glycemic control were recruited from the Detroit Veteran's Administration Hospital and randomized to Technology-Enhanced Coaching ...[more]

PMID: 28132876

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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: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.

Project description:BackgroundWomen experience changes both physically and psychologically during their transition to motherhood. The postnatal period is a critical time for women to develop maternal self-efficacy. Mobile health interventions may offer a way to reach women during this critical period to offer support and information. Essential Coaching for Every Mother is a text message program that seeks to educate and support women during the first 6 weeks postpartum.ObjectiveThe primary effectiveness objective is to compare the effectiveness of the Essential Coaching for Every Mother program on maternal psychosocial outcomes (self-efficacy, social support, postpartum depression, and postpartum anxiety) immediately after the intervention and 6 months postpartum, collectively as well as stratified by parity. The primary implementation objective is to evaluate the implementation extent and quality of the Essential Coaching for Every Mother program.MethodsThis will be a hybrid type 1 effectiveness-implementation randomized controlled trial. A total of 140 mothers-to-be or new mothers from Nova Scotia will be recruited and randomized to the intervention or control arm, stratified by parity. The intervention arm will receive the Essential Coaching for Every Mother program, which consists of 53 messages sent twice a day for the first 2 weeks and daily for weeks 3 through 6. The control group will receive usual care. Messages are personalized based on the infant's age and the woman's self-selected preference for breastfeeding or formula feeding and tailored with the infant's name and gender. Women can enroll in the program if they are ≥37 weeks pregnant or within 10 days postpartum, with the first message designed to be sent on the second evening after birth. The actual number of messages received will vary based on the timing of enrollment and the infant's date of birth. Participants will complete questionnaires assessing self-efficacy, social support, and postpartum depression and anxiety at baseline (enrollment after birth) and 6 weeks (postintervention) and 6 months postpartum. Implementation data will be collected throughout the trial, and evaluation feedback will be collected at 6 weeks from women who received the intervention.ResultsRecruitment for this study started on January 5, 2021, and is currently ongoing, with an anticipated date of recruitment completion of January 2022.ConclusionsThis study will assess the effectiveness of a postpartum text message program to improve maternal self-efficacy and social support while decreasing postpartum depression and anxiety. It will also shed light on the implementation effectiveness of the program.Trial registrationClinicalTrials.gov NCT04730570; https://clinicaltrials.gov/ct2/show/NCT04730570.International registered report identifier (irrid)DERR1-10.2196/27138.

Project description:BackgroundType 2 diabetes mellitus (T2DM) is a leading cause of morbidity and mortality globally, with adverse health consequences largely related to hyperglycemia. Despite clinical practice guideline recommendations, effective pharmacotherapy, and interventions to support patients and providers, up to 60% of patients diagnosed with T2DM are estimated to have hemoglobin A1c (HbA1c) levels above the recommended targets owing to multilevel barriers hindering optimal glycemic control.ObjectiveThe aim of this study is to compare changes in HbA1c levels among patients with suboptimally controlled T2DM who were offered the opportunity to use an intermittently viewed continuous glucose monitor and receive personalized low-carbohydrate nutrition counseling (<100 g/day) versus those who received usual care (UC).MethodsThis was a 12-month, pragmatic, randomized quality improvement program. All adult patients with T2DM who received primary care at a university-affiliated primary care clinic (N=1584) were randomized to either the UC or the enhanced care (EC) group. Within each program arm, we identified individuals with HbA1c >7.5% (58 mmol/mol) who were medically eligible for tighter glycemic control, and we defined these subgroups as UC-high risk (UC-HR) or EC-HR. UC-HR participants (n=197) received routine primary care. EC-HR participants (n=185) were invited to use an intermittently viewed continuous glucose monitor and receive low-carbohydrate nutrition counseling. The primary outcome was mean change in HbA1c levels from baseline to 12 months using an intention-to-treat difference-in-differences analysis comparing EC-HR with UC-HR groups. We conducted follow-up semistructured interviews to understand EC-HR participant experiences with the intervention.ResultsHbA1c decreased by 0.41% (4.5 mmol/mol; P=.04) more from baseline to 12 months among participants in the EC-HR group than among those in UC-HR; however, only 61 (32.9%) of 185 EC-HR participants engaged in the program. Among the EC-HR participants who wore continuous glucose monitors (61/185, 32.9%), HbA1c was 1.1% lower at 12 months compared with baseline (P<.001). Interviews revealed themes related to EC-HR participants' program engagement and continuous glucose monitor use.ConclusionsAmong patients with suboptimally controlled T2DM, a combined approach that includes continuous glucose monitoring and low-carbohydrate nutrition counseling can improve glycemic control compared with the standard of care.

Project description:ObjectivesThe objectives of this study were to determine whether a technology-enhanced weight-loss program, using a home pet health technology ecosystem, is an effective tool in feline weight-loss management in multiple-cat households and to evaluate its impact on cat behavior.MethodsThe study was a prospective parallel unmasked block-randomized controlled trial comparing two weight loss intervention groups: (1) traditional group with dietary restriction alone (n = 9); (2) technology group that used dietary restriction, digital scales, smart feeders, activity monitors and pet treat cameras (n = 6). A 12-week weight-loss program of client-owned indoor-only two- or three-cat households with at least one overweight cat was conducted in Canada and the USA. Owner impressions of the technology, weight loss rates, smart feeder data, activity monitor data and health-related quality of life (HRQoL) were assessed.ResultsThe study was completed by 9/15 traditional group and 6/10 technology group cats. Dropouts were mainly due to owner issues unrelated to the study. The pet health technology ecosystem received favorable reviews (six responders). Smart feeders and home scales were perceived as valuable additions, while activity monitors and pet treat cameras were valued lower. The average weekly weight-loss rate (percent loss of initial body weight) was higher (P = 0.036) in the technology group (0.694%) than in the traditional group (0.175%). Although not associated with weight-loss rates, technology group cats trended toward grazing feeding patterns and decreased daily activity counts, while HRQoL increased, on average, for all cats.Conclusions and relevanceThis introductory investigation suggests that a technology-enhanced weight-loss program would be accepted by cat owners and may deliver advantageous outcomes in multiple-cat households, providing an effective and practical tool in feline weight-loss strategies that will continue to evolve as new technologies become available. It also illustrates the potential value of data gathered from home monitoring devices and digital diaries, providing deeper insights into pet behavior.

Project description:BackgroundGoals for Eating and Moving (GEM) is a technology-assisted health coaching intervention to improve weight management in primary care at the Veterans Health Administration (VHA) that we designed through prior rigorous formative studies. GEM is integrated within the patient-centered medical home and utilizes student health coach volunteers to counsel patients and encourage participation in VHA's intensive weight management program, MOVE!. The primary aim of this study was to determine the feasibility and acceptability of GEM when compared to Enhanced Usual Care (EUC). Our secondary aim was to test the impact of GEM on weight, diet and physical activity when compared to EUC.MethodsVeterans with a Body Mass Index ≥30 kg/m2 or 25-29.9 kg/m2 with comorbidities (n = 45) were recruited in two phases and randomized to GEM (n = 22) or EUC (n = 23). We collected process measures (e.g. number of coaching calls completed, number and types of lifestyle goals, counseling documentation) and qualitative feedback on quality of counseling and acceptability of call duration. We also measured weight and behavioral outcomes.ResultsGEM participants reported receiving high quality counseling from health coaches and that call duration and frequency were acceptable. They received 5.9 (SD = 3.7) of 12 coaching calls on average, and number of coaching calls completed was associated with greater weight loss at 6-months in GEM participants (Spearman Coefficient = 0.71, p < 0.001). Four participants from GEM and two from EUC attended the MOVE! program. PCPs completed clinical reminders in 12% of PCP visits with GEM participants. Trends show that GEM participants (n = 21) tended to lose more weight at 3-, 6-, and 12-months as compared to EUC, but this was not statistically significant. There were no significant differences in diet or physical activity.ConclusionsWe found that a technology assisted health coaching intervention delivered within primary care using student health coaches was feasible and acceptable to Veteran patients. This pilot study helped elucidate challenges such as low provider engagement, difficulties with health coach continuity, and low patient attendance in MOVE! which we have addressed and plan to test in future studies.Trial registrationNCT03006328 Retrospectively registered on December 30, 2016.

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Study protocol: The Technology-Enhanced Coaching (TEC) program to improve diabetes outcomes - A randomized controlled trial.

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Study protocol: The Technology-Enhanced Coaching (TEC) program to improve diabetes outcomes - A randomized controlled trial.

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