Dataset Information

Assessing the feasibility and acceptability of Changing Health for the management of prediabetes: protocol for a pilot study of a digital behavioural intervention.

ABSTRACT: Background:The prevalence of prediabetes is rapidly rising in the UK, largely associated with an increase in obesity. Lifestyle programmes that provide support to make and sustain dietary and physical activity behavioural changes are necessary to initiate and maintain weight loss. However, these programmes are often intensive and time consuming. Given the magnitude of the problem, there is a need for behavioural interventions that can be delivered at scale. Digital interventions can address some of the aforementioned issues. The primary aim of the present study is to assess the feasibility and acceptability of a digital intervention called Changing Health that provides structured education and lifestyle behaviour change support to adults with prediabetes. Methods:A single-group pilot study will be undertaken. We aim to recruit 40 participants with prediabetes defined by HbA1c or fasting plasma glucose (FPG), aged between 18 and 75?years with a BMI???25. Participants will receive the digital intervention (a mobile phone app incorporating structured education and behavioural tools to support lifestyle behaviour change) with the aim of losing and maintaining 5-6% of their baseline body weight. Each participant will receive 100?min of lifestyle coaching over the 9-month intervention period and will have continued access to the digital intervention. Clinical outcome measures will be collected during four visits to our clinical research facility: two visits at baseline, one visit at month 3, and one visit at month 9. These secondary outcome measures will include diet, physical activity, sleep, metabolic control, body composition, cardiorespiratory fitness, and cardiovascular function. To measure primary outcomes, an embedded qualitative study will be conducted to obtain data on feasibility and acceptability of the intervention. Discussion:This pilot study will establish whether Changing Health is feasible and acceptable to adults with prediabetes. Clinical outcome measures will provide estimates of variability to inform sample size calculations, and qualitative data generated will inform any necessary refinements to the intervention. This will provide a platform for a larger evaluation to assess the effectiveness of Changing Health for changing diet and physical activity to initiate and maintain weight loss in adults with prediabetes. Trial registration:ISRCTN Registry: ISRCTN69270299.

SUBMITTER: Cassidy S

PROVIDER: S-EPMC6878649 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Assessing the feasibility and acceptability of Changing Health for the management of prediabetes: protocol for a pilot study of a digital behavioural intervention.

Cassidy Sophie S Okwose Nduka N Scragg Jadine J Houghton David D Ashley Kirsten K Trenell Michael I MI Jakovljevic Djordje G DG Hallsworth Kate K Avery Leah L

Pilot and feasibility studies 20191126

<h4>Background</h4>The prevalence of prediabetes is rapidly rising in the UK, largely associated with an increase in obesity. Lifestyle programmes that provide support to make and sustain dietary and physical activity behavioural changes are necessary to initiate and maintain weight loss. However, these programmes are often intensive and time consuming. Given the magnitude of the problem, there is a need for behavioural interventions that can be delivered at scale. Digital interventions can addr ...[more]

PMID: 31788325

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Project description:BackgroundThe World Health Organization recommends that community health workers (CHWs) receive a mix of financial and non-financial incentives, yet notes that there is limited evidence to support the use of one type of incentive (i.e. financial or non-financial) over another. In preparation for a larger scale trial, we investigated the acceptability and feasibility of two different forms of incentives for CHWs in Malang District, Indonesia.MethodsCHWs working on a cardiovascular disease (CVD) risk screening and management programme in two villages were assigned to receive either a financial or non-financial incentive for 6 months. In the financial incentives village, CHWs (n = 20) received 16,000 IDR (USD 1.1) per patient followed up or 500,000 IDR (USD 34.1) if they followed up 100% of their assigned high-risk CVD patients each month. In the non-financial incentive village, CHWs (n = 20) were eligible to receive a Quality Care Certificate for following up the highest number of high-risk CVD patients each month, awarded in a public ceremony. At the end of the 6-month intervention period, focus group discussions were conducted with CHWs and semi-structured interviews with programme administrators to investigate acceptability, facilitators and barriers to implementation and feasibility of the incentive models. Data on monthly CHW follow-up activity were analysed using descriptive statistics to assess the preliminary impact of each incentive on service delivery outcomes, and CHW motivation levels were assessed pre- and post-implementation.ResultsFactors beyond the control of the study significantly interrupted the implementation of the financial incentive, particularly the threat of violence towards CHWs due to village government elections. Despite CHWs reporting that both the financial and non-financial incentives were acceptable, programme administrators questioned the sustainability of the non-financial incentive and reported CHWs were ambivalent towards them. CHW service delivery outcomes increased 17% for CHWs eligible for the non-financial incentive and 21% for CHWs eligible for the financial incentive. There was a statistically significant increase (p < 0.0001) in motivation scores for the performance domain in both villages.ConclusionIt was feasible to deliver both a performance-based financial and non-financial incentive to CHWs in Malang District, Indonesia, and both incentive types were acceptable to CHWs and programme administrators. Evidence of preliminary effectiveness also suggests that both the financial and non-financial incentives were associated with improved motivation and service delivery outcomes. These findings will inform the next phase of incentive design, in which incentive feasibility and preliminary effectiveness will need to be considered alongside their longer-term sustainability within the health system.

Project description:BackgroundGeneralized anxiety disorder (GAD) is characterized by excessive worry that is difficult to control and has high comorbidity with mood disorders including depression. Individuals experience long wait times for diagnosis and often face accessibility barriers to treatment. There is a need for a digital solution that is accessible and acceptable to those with GAD.ObjectiveThis paper aims to describe the development of a digital intervention prototype of acceptance and commitment therapy (ACT) for GAD that sits within an existing well-being app platform, BioBase. A pilot feasibility study evaluating acceptability and usability is conducted in a sample of adults with a diagnosis of GAD, self-referred to the study.MethodsPhase 1 applied the person-based approach (creation of guiding principles, intervention design objectives, and the key intervention features). In Phase 2 participants received the app-based therapeutic and paired wearable for 2 weeks. Self-report questionnaires were obtained at baseline and posttreatment. The primary outcome was psychological flexibility (Acceptance and Action Questionnaire-II [AAQ-II]) as this is the aim of ACT. Mental well-being (Warwick-Edinburgh Mental Well-being Scale [WEMWBS]) and symptoms of anxiety (7-item Generalized Anxiety Disorder Assessment [GAD-7]) and depression (9-item Patient Health Questionnaire [PHQ-9]) were also assessed. Posttreatment usability was assessed via self-report measures (System Usability Scale [SUS]) in addition to interviews that further explored feasibility of the digital intervention in this sample.ResultsThe app-based therapeutic was well received. Of 13 participants, 10 (77%) completed the treatment. Results show a high usability rating (83.5). Participants found the digital intervention to be relevant, useful, and helpful in managing their anxiety. Participants had lower anxiety (d=0.69) and depression (d=0.84) scores at exit, and these differences were significantly different from baseline (P=.03 and .008 for GAD-7 and PHQ-9, respectively). Participants had higher psychological flexibility and well-being scores at exit, although these were not significantly different from baseline (P=.11 and .55 for AAQ-II and WEMWBS, respectively).ConclusionsThis ACT prototype within BioBase is an acceptable and feasible digital intervention in reducing symptoms of anxiety and depression. This study suggests that this intervention warrants a larger feasibility study in adults with GAD.

Project description:BackgroundChildhood cancer survivors are at increased risk of cardiometabolic complications that are exacerbated by poor health behaviors. Critically, many survivors do not meet physical activity guidelines.ObjectiveThe primary aim was to evaluate the feasibility and acceptability of iBounce, a digital health intervention for educating and engaging survivors in physical activity. Our secondary aims were to assess the change in survivors' physical activity levels and behaviors, aerobic fitness, and health-related quality of life (HRQoL) after participating in the iBounce program.MethodsWe recruited survivors aged 8 to 13 years who were ≥12 months post cancer treatment completion. The app-based program involved 10 educational modules, goal setting, and home-based physical activities monitored using an activity tracker. We assessed objective physical activity levels and behaviors using cluster analysis, aerobic fitness, and HRQoL at baseline and after the intervention (week 12). Parents were trained to reassess aerobic fitness at home at follow-up (week 24).ResultsIn total, 30 participants opted in, of whom 27 (90%) completed baseline assessments, and 23 (77%) commenced iBounce. Our opt-in rate was 59% (30/51), and most (19/23, 83%) of the survivors completed the intervention. More than half (13/23, 57%) of the survivors completed all 10 modules (median 10, IQR 4-10). We achieved a high retention rate (19/27, 70%) and activity tracker compliance (15/19, 79%), and there were no intervention-related adverse events. Survivors reported high satisfaction with iBounce (median enjoyment score 75%; ease-of-use score 86%), but lower satisfaction with the activity tracker (median enjoyment score 60%). Parents reported the program activities to be acceptable (median score 70%), and their overall satisfaction was 60%, potentially because of technological difficulties that resulted in the program becoming disjointed. We did not observe any significant changes in physical activity levels or HRQoL at week 12. Our subgroup analysis for changes in physical activity behaviors in participants (n=11) revealed five cluster groups: most active, active, moderately active, occasionally active, and least active. Of these 11 survivors, 3 (27%) moved to a more active cluster group, highlighting their engagement in more frequent and sustained bouts of moderate-to-vigorous physical activity; 6 (56%) stayed in the same cluster; and 2 (18%) moved to a less active cluster. The survivors' mean aerobic fitness percentiles increased after completing iBounce (change +17, 95% CI 1.7-32.1; P=.03) but not at follow-up (P=.39).ConclusionsWe demonstrated iBounce to be feasible for delivery and acceptable among survivors, despite some technical difficulties. The distance-delivered format provides an opportunity to engage survivors in physical activity at home and may address barriers to care, particularly for regional or remote families. We will use these pilot findings to evaluate an updated version of iBounce.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12621000259842; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=ACTRN12621000259842.

Project description:BackgroundHeart failure (HF) is one of the leading causes of hospital admissions. Clinical (eg, complex comorbidities and low ejection fraction) and social needs factors (eg, access to transportation, food security, and housing security) have both contributed to hospitalizations, emphasizing the importance of increased clinical and social needs support at home. Digital platforms designed for remote monitoring of HF can improve clinical outcomes, but their effectiveness has been limited by patient barriers such as lack of familiarity with technology and unmet social care needs. To address these barriers, this study explored combining a digital platform with community health worker (CHW) social needs care for patients with HF.ObjectiveWe aim to determine the feasibility and acceptability of an intervention combining digital platform use and CHW social needs care for patients with HF.MethodsAdults (aged ≥18 years) with HF receiving care at a single health care institution and with a history of hospital admission in the previous 12 months were enrolled in a single-arm pilot study from July to November 2021 (N=14). The 30-day intervention used a digital platform within a mobile app that included symptom questionnaire and educational videos connected to a biometric sensor (tracking heart rate, oxygenation, and steps taken), a digital weight scale, and a digital blood pressure monitor. All patients were paired with a CHW who had access to the digital platform data. A CHW provided routine phone calls to patients throughout the study period to discuss their biometric data and to address barriers to any social needs. Feasibility outcomes were patient use of the platform and engagement with the CHW. The acceptability outcome was patient willingness to use the intervention again.ResultsParticipants (N=14) were 67.7 (SD 11.7) years old; 8 (57.1%) were women, and 7 (50%) were insured by Medicare. Participants wore the sensor for 82.2% (n=24.66) of study days with an average of 13.5 (SD 2.1) hours per day. Participants used the digital blood pressure monitor and digital weight scale for an average of 1.2 (SD 0.17) times per day and 1.1 (SD 0.12) times per day, respectively. All participants completed the symptom questionnaire on at least 71% (n=21.3) of study days; 11 (78.6%) participants had ≥3 CHW interactions, and 11 (78.6%) indicated that if given the opportunity, they would use the platform again in the future. Exit interviews found that despite some platform "glitches," participants generally found the remote monitoring platform to be "helpful" and "motivating."ConclusionsA novel intervention combining a digital platform with CHW social needs care for patients with HF was feasible and acceptable. The majority of participants were engaged throughout the study and indicated their willingness to use the intervention again. A future clinical trial is needed to determine the effectiveness of this intervention.

Project description:BackgroundHeart failure (HF) is a burdensome condition and a leading cause of 30-day hospital readmissions in the United States. Clinical and social factors are key drivers of hospitalization. These 2 strategies, digital platforms and home-based social needs care, have shown preliminary effectiveness in improving adherence to clinical care plans and reducing acute care use in HF. Few studies, if any, have tested combining these 2 strategies in a single intervention.ObjectiveThis study aims to perform a pilot randomized controlled trial assessing the acceptability, feasibility, and preliminary effectiveness of a 30-day digitally-enabled community health worker (CHW) intervention in HF.MethodsAdults hospitalized with a diagnosis of HF at an academic hospital were randomly assigned to receive digitally-enabled CHW care (intervention; digital platform +CHW) or CHW-enhanced usual care (control; CHW only) for 30 days after hospital discharge. Primary outcomes were feasibility (use of the platform) and acceptability (willingness to use the platform in the future). Secondary outcomes assessed preliminary effectiveness (30-day readmissions, emergency department visits, and missed clinic appointments).ResultsA total of 56 participants were randomized (control: n=31; intervention: n=25) and 47 participants (control: n=28; intervention: n=19) completed all trial activities. Intervention participants who completed trial activities wore the digital sensor on 78% of study days with mean use of 11.4 (SD 4.6) hours/day, completed symptom questionnaires on 75% of study days, used the blood pressure monitor 1.1 (SD 0.19) times/day, and used the digital weight scale 1 (SD 0.13) time/day. Of intervention participants, 100% responded very or somewhat true to the statement "If I have access to the [platform] moving forward, I will use it." Some (n=9, 47%) intervention participants indicated they required support to use the digital platform. A total of 19 (100%) intervention participants and 25 (89%) control participants had ≥5 CHW interactions during the 30-day study period. All intervention (n=19, 100%) and control (n=26, 93%) participants who completed trial activities indicated their CHW interactions were "very satisfying." In the full sample (N=56), fewer participants in the intervention group were readmitted 30 days after hospital discharge compared to the control group (n=3, 12% vs n=8, 26%; P=.12). Both arms had similar rates of missed clinic appointments and emergency department visits.ConclusionsThis pilot trial of a digitally-enabled CHW intervention for HF demonstrated feasibility, acceptability, and a clinically relevant reduction in 30-day readmissions among participants who received the intervention. Additional investigation is needed in a larger trial to determine the effect of this intervention on HF home management and clinical outcomes.Trial registrationClinicaltrials.gov NCT05130008; https://clinicaltrials.gov/study/NCT05130008.International registered report identifier (irrid)RR2-10.2196/55687.

Dataset Information

Assessing the feasibility and acceptability of Changing Health for the management of prediabetes: protocol for a pilot study of a digital behavioural intervention.

Publications

Assessing the feasibility and acceptability of Changing Health for the management of prediabetes: protocol for a pilot study of a digital behavioural intervention.

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