Web-based self-management with and without coaching for type 2 diabetes patients in primary care: design of a randomized controlled trial.
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SUBMITTER: van Vugt M
PROVIDER: S-EPMC3840688 | biostudies-other | 2013 Nov
REPOSITORIES: biostudies-other
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Web-based self-management with and without coaching for type 2 diabetes patients in primary care: design of a randomized controlled trial.
van Vugt Michael M de Wit Maartje M Hendriks Steven H SH Roelofsen Yvonne Y Bilo Henk Jg HJ Snoek Frank J FJ
BMC endocrine disorders 20131116
<h4>Background</h4>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 impro ...[more]
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Project description:This article describes the methodology, recruitment, participant characteristics, and sustained, intensive stakeholder engagement for Project ACE (Achieving control, Connecting resources, Empowering families). Project ACE is a randomized controlled trial of children and youth ages 8-16 with type 1 diabetes evaluating the impact of tailored self-management resources on hemoglobin A1c (A1c) and quality of life (QOL). Despite strong evidence that controlling A1c reduces long-term complications, <25% of US youth with type 1 diabetes meet A1c targets. Many interventions are efficacious in improving A1c and QOL for these youth, whose families often struggle with the substantial demands of the treatment regimen. However, most such interventions are ineffective in the real world due to lack of uptake by families and limited healthcare system resources. Project ACE is a multi-site trial designed to improve diabetes outcomes by tailoring existing, evidence-based interventions to meet families' needs and preferences. We hypothesize that this family-centered approach will result in better A1c and QOL than usual care. Project ACE has recruited and randomized 214 eligible 8-16year old youth and their parents. The 9-month intervention consisted of 4 group sessions tailored to families' self-management barriers as identified by a validated instrument. Outcomes including A1c and QOL for parents and youth will be assessed for 1year after the intervention. Stakeholder engagement was used to enhance this trial's recruitment, retention and integration into routine clinical care. Findings will inform implementation and dissemination of family-centered approaches to address self-management barriers. TRIAL REGISTRATION NUMBER:NCT02024750 Trial Registrar: Clinicaltrials.gov, https://clinicaltrials.gov/ct2/show/NCT02024750.
| S-EPMC5535788 | biostudies-literature
Project description:Most adults undergoing cardiac surgery suffer from moderate to severe pain for up to 6 days after surgery. Individual barriers and attitudes regarding pain and its relief make patients reluctant to report their pain and ask for analgesic medication, which results in inadequate pain management. More innovative educational interventions for postoperative pain relief are needed. We developed a Web-based nursing intervention to influence patient's involvement in postoperative pain management. The intervention (SOULAGE-TAVIE) includes a preoperative 30-minute Web-based session and 2 brief face-to-face postoperative booster sessions. The Web application generates reflective activities and tailored educational messages according to patients' beliefs and attitudes. The messages are transmitted through videos of a virtual nurse, animations, stories, and texts.The aim of this single-blinded pilot randomized trial was to investigate the preliminary effects of a virtual nursing intervention (SOULAGE-TAVIE) to improve pain relief in patients undergoing cardiac surgery.Participants (N = 60) were adults scheduled for their first cardiac surgery. They were randomly assigned to the experimental group using SOULAGE-TAVIE (n = 30) or the control group using usual care, including an educational pamphlet and postoperative follow-up (n = 30). Data were collected through questionnaires at the time of admission and from day 1 to day 7 after surgery with the help of a blinded research assistant. Outcomes were pain intensity, pain interference with daily activities, patients' pain barriers, tendency to catastrophize in face of pain, and analgesic consumption.The two groups were comparable at baseline across all demographic measures. Results revealed that patients in the experimental group did not experience less intense pain, but they reported significantly less pain interference when breathing/coughing (P = .04). A severe pain interference with breathing/coughing (pain ranked ? 7/10) was reported on day 3 after surgery by 15% of the patients in the experimental group (4/27), as compared to 44% (7/16) in the control group. On day 7 after surgery, participants in the experimental group also exhibited fewer pain-related barriers as measured by the Barriers Questionnaire-II (mean 10.6, SD 8.3) than patients in the control group (mean 15.8, SD 7.3, P = .02). No difference was found for pain catastrophizing. However, in both groups, means revealed a lower tendency to catastrophize pain before surgery as measured by the Pain Catastrophizing Scale (control group mean 1.04, SD 0.74; experimental group mean 1.10, SD 0.95) and after surgery (control group mean score 1.19, SD 0.94; experimental group mean score 1.08, SD 0.99). Finally, the experimental group consumed more opioid medication (mean 31.2 mg, SD 23.2) than the control group (mean 18.8 mg, SD 15.3, P = .001).This pilot study provides promising results to support the benefits of this new Web-tailored approach that can increase accessibility to health education and promote pain relief without generating more costs.Clinicaltrials.gov NCT01084018; http://www.clinicaltrials.gov/ct2/show/NCT01084018 (Archived by WebCite® at http://www.webcitation.org/6CoTBkIoT).
| S-EPMC3799541 | biostudies-literature
Project description:BackgroundMobile health applications have been developed to support diabetes self-management, but their effectiveness could depend on patient engagement. Therefore, patient engagement must be examined through multifactorial tailored behavioral interventions from an individual perspective.ObjectiveThis study aims to evaluate the usefulness of a novel user utility score (UUS) as a tool to measure patient engagement by using a mobile health application for diabetes management.MethodsWe conducted a subanalysis of results from a 12-month randomized controlled trial of a tailored mobile coaching (TMC) system among insurance policyholders with type 2 diabetes. UUS was calculated as the sum of the scores for 4 major core components (range 0-8): frequency of self-monitoring blood glucose testing, dietary and exercise records, and message reading rate. We explored the association between UUS for the first 3 months and glycemic control over 12 months. In addition, we investigated the relationship of UUS with blood pressure, lipid profile, and self-report scales assessing diabetes self-management.ResultsWe divided 72 participants into 2 groups based on UUS for the first 3 months: UUS:0-4 (n=38) and UUS:5-8 (n=34). There was a significant between-group difference in glycated hemoglobin test (HbA1c) levels for the 12-months study period (P=.011). The HbA1c decrement at 12 months in the UUS:5-8 group was greater than that of the UUS:0-4 group [-0.92 (SD 1.24%) vs -0.33 (SD 0.80%); P=.049]. After adjusting for confounding factors, UUS was significantly associated with changes in HbA1c at 3, 6, and 12 months; the regression coefficients were -0.113 (SD 0.040; P=.006), -0.143 (SD 0.045; P=.002), and -0.136 (SD 0.052; P=.011), respectively. Change differences in other health outcomes between the 2 groups were not observed throughout a 12-month follow-up.ConclusionsUUS as a measure of patient engagement was associated with changes in HbA1c over the study period of the TMC system and could be used to predict improved glycemic control in diabetes self-management through mobile health interventions.Trial registrationClinicalTrial.gov NCT03033407; https://clinicaltrials.gov/ct2/show/NCT03033407.
| S-EPMC7946585 | biostudies-literature
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:Background:Technology-assisted self-management programs are increasingly recommended to patients with long-term conditions such as diabetes. However, there are a number of personal and external factors that affect patients' abilities to engage with and effectively utilize such programs. A randomized controlled trial of a multi-modal online program for diabetes self-management (BetaMe/Melon) was conducted in a primary care setting, and a process evaluation was completed at the end of the study period.Objective:This process evaluation aimed to examine the utilization patterns of BetaMe/Melon, identify which components participants found most (and least) useful, and identify areas of future improvement.Methods:Process evaluation data were collected for intervention arm participants from 3 sources: (1) the mobile/web platform (to identify key usage patterns over the 16-week core program), (2) an online questionnaire completed during the final study assessment, and (3) interviews conducted with a subset of participants following the study period. Participants were classified as "actively engaged" if any usage data was recorded for the participant (in any week), and patterns were reported by age, gender, ethnicity, and diabetes/prediabetes status. The online questionnaire asked participants about the usefulness of the program and whether they would recommend BetaMe/Melon to others according to a 5-point Likert Scale. Of 23 invited participants, 18 participated in a digitally recorded, semistructured telephone interview. Interview data were thematically analyzed.Results:Out of the 215 participants, 198 (92%) received an initial health coaching session, and 160 (74%) were actively engaged with the program at some point during the 16-week core program. Engagement varied by demographic, with women, younger participants, and ethnic majority populations having higher rates of engagement. Usage steadily declined from 50% at Week 0 to 23% at Week 15. Participants ranked component usefulness as education resources (63.7%), health coaches (59.2%), goal tracking (48.8%), and online peer support (42.1%). Although 53% agreed that the program was easy to use, 64% would recommend the program to others. Interview participants found BetaMe/Melon useful overall, with most identifying beneficial outcomes such as increased knowledge, behavioral changes, and weight loss. Barriers to engagement were program functionality, internet connectivity, incomplete delivery of all program components, and participant motivation. Participants suggested a range of improvements to the BetaMe/Melon program.Conclusions:The program was generally well received by participants; active engagement was initially high, although it declined steadily. Maintaining participant engagement over time, individualizing programs, and addressing technical barriers are important to maximize potential health benefits from online diabetes self-management programs.Trial registration:Australian New Zealand Clinical Trial Registry ACTRN12617000549325; https://tinyurl.com/y622b27q.
| S-EPMC7738254 | biostudies-literature
Project description:ObjectiveTo determine the effectiveness of a web-based self-management programme for people with type 2 diabetes in improving glycaemic control and reducing diabetes-related distress.Methods and designIndividually randomised two-arm controlled trial.Setting21 general practices in England.ParticipantsAdults aged 18 or over with a diagnosis of type 2 diabetes registered with participating general practices.Intervention and comparatorUsual care plus either Healthy Living for People with Diabetes (HeLP-Diabetes), an interactive, theoretically informed, web-based self-management programme or a simple, text-based website containing basic information only.Outcomes and data collectionJoint primary outcomes were glycated haemoglobin (HbA1c) and diabetes-related distress, measured by the Problem Areas in Diabetes (PAID) scale, collected at 3 and 12 months after randomisation, with 12 months the primary outcome point. Research nurses, blind to allocation collected clinical data; participants completed self-report questionnaires online.AnalysisThe analysis compared groups as randomised (intention to treat) using a linear mixed effects model, adjusted for baseline data with multiple imputation of missing values.ResultsOf the 374 participants randomised between September 2013 and December 2014, 185 were allocated to the intervention and 189 to the control. Final (12 month) follow-up data for HbA1c were available for 318 (85%) and for PAID 337 (90%) of participants. Of these, 291 (78%) and 321 (86%) responses were recorded within the predefined window of 10-14 months. Participants in the intervention group had lower HbA1c than those in the control (mean difference -0.24%; 95% CI -0.44 to -0.049; p=0.014). There was no significant overall difference between groups in the mean PAID score (p=0.21), but prespecified subgroup analysis of participants who had been more recently diagnosed with diabetes showed a beneficial impact of the intervention in this group (p = 0.004). There were no reported harms.ConclusionsAccess to HeLP-Diabetes improved glycaemic control over 12 months.Trial registration numberISRCTN02123133.
| S-EPMC5623569 | biostudies-literature
Project description:BackgroundThe effect of computer- or human-delivered personalized feedback on the effectivess of web-based behavior change platforms for weight loss is unclear.ObjectiveWe aimed to compare the effectiveness of a web-based behavior change intervention personalized through either computerized or human-delivered feedback with a nonpersonalized intervention in promoting weight loss in community-based adults with overweight or obesity.MethodsThis pragmatic, 3-group, parallel-arm, randomized trial recruited students and staff in a Brazilian public university who were aged 18 to 60 years, had a BMI of ≥25 kg/m2, and were not pregnant. Participants were allocated to one of 3 groups: platform only (24-week behavior change program delivered using a web platform with personalized computer-delivered feedback), platform plus coaching (same 24-week web-based behavior change program plus 12 weeks of personalized feedback delivered online by a dietitian), or waiting list (nonpersonalized dietary and physical activity recommendations delivered through an e-booklet and videos). Self-reported weight at 24 weeks was the primary outcome. Changes in dietary and physical activity habits within 24 weeks were secondary outcomes.ResultsAmong the 1298 participants, 375 (28.89%) were lost to follow-up. In the intention-to-treat analysis, the platform-only and platform plus coaching groups had greater mean weight loss than the waiting-list group at 24 weeks (-1.08 kg, 95% CI -1.41 to -0.75 vs -1.57 kg, 95% CI -1.92 to -1.22 vs -0.66 kg, 95% CI -0.98 to -0.34, respectively). The platform-only and platform plus coaching groups, compared with the waiting list group, had a greater increase in the consumption of vegetables (3%, 95% CI 1% to 6% vs 5%, 95% CI 2% to 8% vs -3%, 95% CI -5% to 0%) and fruits (9%, 95% CI 6% to 12% vs 6%, 95% CI 2% to 9% vs 2%, 95% CI 0% to 6%) and a larger reduction in ultraprocessed food intake (-18%, 95% CI -23% to -13% vs -25%, 95% CI -30% to -20% vs -12%, 95% CI -16% to -8%). Changes in physical activity did not differ across the groups. Engagement was higher in the platform plus coaching group than in the platform-only group (7.6 vs 5.2 completed sessions; P=.007). Longer usage of the platform was associated with clinically meaningful (≥5%) weight loss (odds ratio 1.02, 95% CI 1.01 to 1.04).ConclusionsThe web-based behavior change programs with computer- and human-delivered personalized feedback led to greater, albeit small-magnitude, weight loss within 24 weeks. Improvement in multiple dietary habits, but not physical activity, were also greater in the personalized programs compared with the nonpersonalized one. The human-delivered personalized feedback by the online dietitian coach increased user engagement with the program and was associated with a significantly higher chance of clinically meaningful weight loss.Trial registrationClinicalTrials.gov NCT03435445; https://clinicaltrials.gov/ct2/show/NCT03435445.International registered report identifier (irrid)RR2-10.2196/10.1186/s12889-018-5882-y.
| S-EPMC7677024 | 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: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:BackgroundThe Diabetes Manual is a type 2 diabetes self-management programme based upon the clinically effective 'Heart Manual'. The 12 week programme is a complex intervention theoretically underpinned by self-efficacy theory. It is a one to one intervention meeting United Kingdom requirements for structured diabetes-education and is delivered within routine primary care.Methods/designIn a two-group cluster randomized controlled trial, GP practices are allocated by computer minimisation to an intervention group or a six-month deferred intervention group. We aim to recruit 250 participants from 50 practices across central England. Eligibility criteria are adults able to undertake the programme with type 2 diabetes, not taking insulin, with HbA1c over 8% (first 12 months) and following an agreed protocol change over 7% (months 13 to 18). Following randomisation, intervention nurses receive two-day training and delivered the Diabetes Manual programme to participants. Deferred intervention nurses receive the training following six-month follow-up. Primary outcome is HbA1c with total and HDL cholesterol; blood pressure, body mass index; self-efficacy and quality of life as additional outcomes. Primary analysis is between-group HbA1c differences at 6 months powered to give 80% power to detect a difference in HbA1c of 0.6%. A 12 month cohort analysis will assess maintenance of effect and assess relationship between self-efficacy and outcomes, and a qualitative study is running alongside.DiscussionThis trial incorporates educational and psychological diabetes interventions into a single programme and assesses both clinical and psychosocial outcomes. The trial will increase our understanding of intervention transferability between conditions, those diabetes related health behaviours that are more or less susceptible to change through efficacy enhancing mechanisms and how this impacts on clinical outcomes.
| S-EPMC1555586 | biostudies-literature