Digital Health Coaching for Type 2 Diabetes: Randomized Controlled Trial of Healthy at Home.
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SUBMITTER: Azelton KR
PROVIDER: S-EPMC8655126 | biostudies-literature |
REPOSITORIES: biostudies-literature
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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).
| S-EPMC5832903 | biostudies-literature
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.
| S-EPMC7076411 | biostudies-literature
Project description:In the US, nearly 11% of adults were living with diagnosed diabetes in 2017, and significant type 2 diabetes (T2D) disparities are experienced by socioeconomically disadvantaged, racial/ethnic minority populations, including Hispanics. The standard 15-min primary care visit does not allow for the ongoing self-management support that is needed to meet the complex needs of individuals with diabetes. "Team-based" chronic care delivery is an alternative approach that supplements physician care with contact from allied health personnel in the primary care setting (e.g., medical assistants; MAs) who are specially trained to provide ongoing self-management support or "health coaching." While rigorous trials have shown MA health coaching to improve diabetes outcomes, less is known about if and how such a model can be integrated within real world, primary care clinic workflows. Medical Assistant Health Coaching for Type 2 Diabetes in Diverse Primary Care Settings - A Pragmatic, Cluster-Randomized Controlled Trial will address this gap. Specifically, this study compares MA health coaching versus usual care in improving diabetes clinical control among N = 600 at-risk adults with T2D, and is being conducted at four primary care clinics that are part of two health systems that serve large, ethnically/racially, and socioeconomically diverse populations in Southern California. Electronic medical records are used to identify eligible patients at both health systems, and to examine change in clinical control over one year in the overall sample. Changes in behavioral and psychosocial outcomes are being evaluated by telephone assessment in a subset (n = 300) of participants, and rigorous process and cost evaluations will assess potential for sustainability and scalability.
| S-EPMC8093013 | biostudies-literature
Project description:Self-management is recognized as the cornerstone of overall diabetes management. Web-based self-management programs have the potential of supporting type 2 diabetes patients with managing their diabetes and reducing the workload for the care provider, where the addition of online coaching could improve patient motivation and reduce program attrition. This study aims to test the hypothesis that a web-based self-management program with coaching will prove more effective on improving patient self-management behavior and clinical outcome measures than a web-based self-management program without coaching.The effects of a web-based self-management program with and without coaching will be tested with a nested randomized controlled trial within a healthcare group in the Netherlands. In one year 220 type 2 diabetes patients will be randomized into an intervention group (n?=?110) or a control group (n?=?110). The control group will receive only the online self-management program. The intervention group will receive the online self-management program and additional online coaching. Participants will be followed for one year, with follow-up measurements at 6 and 12 months.The intervention being tested is set to support type 2 diabetes patients with their diabetes self-management and is expected to have beneficial effects on self-care activities, well being and clinical outcomes. When proven effective this self-management support program could be offered to other health care groups and their type 2 diabetes patients in the Netherlands.Nederlands Trial Register NTR4064.
| S-EPMC3840688 | biostudies-other
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.
| S-EPMC8390579 | biostudies-literature
Project description: Not available
| S-EPMC9194666 | biostudies-literature
Project description:PurposePeer health coaches offer a potential model for extending the capacity of primary care practices to provide self-management support for patients with diabetes. We conducted a randomized controlled trial to test whether clinic-based peer health coaching, compared with usual care, improves glycemic control for low-income patients who have poorly controlled diabetes.MethodWe undertook a randomized controlled trial enrolling patients from 6 public health clinics in San Francisco. Twenty-three patients with a glycated hemoglobin (HbA1C) level of less than 8.5%, who completed a 36-hour health coach training class, acted as peer coaches. Patients from the same clinics with HbA1C levels of 8.0% or more were recruited and randomized to receive health coaching (n = 148) or usual care (n = 151). The primary outcome was the difference in change in HbA1C levels at 6 months. Secondary outcomes were proportion of patients with a decrease in HbA1C level of 1.0% or more and proportion of patients with an HbA1C level of less than 7.5% at 6 months. Data were analyzed using a linear mixed model with and without adjustment for differences in baseline variables.ResultsAt 6 months, HbA1C levels had decreased by 1.07% in the coached group and 0.3% in the usual care group, a difference of 0.77% in favor of coaching (P = .01, adjusted). HbA1C levels decreased 1.0% or more in 49.6% of coached patients vs 31.5% of usual care patients (P = .001, adjusted), and levels at 6 months were less than 7.5% for 22.0% of coached vs 14.9% of usual care patients (P = .04, adjusted).ConclusionsPeer health coaching significantly improved diabetes control in this group of low-income primary care patients.
| S-EPMC3601392 | biostudies-literature
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.
| S-EPMC6465980 | biostudies-literature
Project description:BackgroundDespite the many antihypertensive medications available, two-thirds of patients with hypertension do not achieve blood pressure control. This is thought to be due to a combination of poor patient education, poor medication adherence, and "clinical inertia." The present trial evaluates an intervention consisting of health coaching, home blood pressure monitoring, and home medication titration as a method to address these three causes of poor hypertension control.Methods/designThe randomized controlled trial will include 300 patients with poorly controlled hypertension. Participants will be recruited from a primary care clinic in a teaching hospital that primarily serves low-income populations.An intervention group of 150 participants will receive health coaching, home blood pressure monitoring, and home-titration of antihypertensive medications during 6 months. The control group (n=150) will receive health coaching plus home blood pressure monitoring for the same duration. A passive control group will receive usual care. Blood pressure measurements will take place at baseline, and after 6 and 12 months. The primary outcome will be change in systolic blood pressure after 6 and 12 months. Secondary outcomes measured will be change in diastolic blood pressure, adverse events, and patient and provider satisfaction.DiscussionThe present study is designed to assess whether the 3-pronged approach of health coaching, home blood pressure monitoring, and home medication titration can successfully improve blood pressure, and if so, whether this effect persists beyond the period of the intervention.Trial registrationClinicalTrials.gov identifier: NCT01013857.
| S-EPMC2797520 | biostudies-literature
Project description:BackgroundSystemic lupus erythematosus (SLE), a systemic autoimmune disease with no known cure, remains poorly understood and patients suffer from many gaps in care. Recent work has suggested that dietary and other lifestyle factors play an important role in triggering and propagating SLE in some susceptible individuals. However, the magnitude of influence of these triggers, how to identify pertinent triggers in individual patients, and whether removing these triggers confers clinical benefit is unknown.ObjectiveTo demonstrate that a digital therapeutic intervention, utilizing a mobile app that allows self-tracking of dietary, environmental, and lifestyle triggers, paired with telehealth coaching, added to usual care, improves quality of life in patients with SLE compared with usual care alone.MethodsIn this randomized controlled pilot study, adults with SLE were assigned to a 16-week digital therapeutic intervention plus usual care or usual care alone. Primary outcome measures were changes from baseline to 16 weeks on 3 validated health-related quality of life (HRQoL) tools: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Brief Pain Inventory-Short Form (BPI-SF), and Lupus Quality of Life (LupusQoL).ResultsA total of 50 patients were randomized (23 control, 27 intervention). In per-protocol analysis, the intervention group achieved significantly greater improvement than the control group in 9 of 11 domains: FACIT-F (34% absolute improvement for the intervention group vs -1% for the control group, P<.001), BPI-SF-Pain Interference (25% vs 0%, P=.02), LupusQoL-Planning (17% vs 0%, P=.004), LupusQoL-Pain (13% vs 0%, P=.004), LupusQoL-Emotional Health (21% vs 4%, P=.02), and LupusQoL-Fatigue (38% vs 13%, P<.001) were significant when controlling for multiple comparisons; BPI-SF-Pain Severity (13% vs -6%, P=.049), LupusQoL-Physical Health (17% vs 3%, P=.049), and LupusQoL-Burden to Others (33% vs 4%, P=.04) were significant at an unadjusted 5% significance level.ConclusionsA digital therapeutic intervention that pairs self-tracking with telehealth coaching to identify and remove dietary, environmental, and lifestyle symptom triggers resulted in statistically significant, clinically meaningful improvements in HRQoL when added to usual care in patients with SLE.Trial registrationClinicalTrials.gov NCT03426384; https://clinicaltrials.gov/ct2/show/NCT03426384.
| S-EPMC7609202 | biostudies-literature