Dataset Information

Qualitative study of barriers to clinical trial retention in adults with recently diagnosed type 1 diabetes.

ABSTRACT:

Objectives

Regular physical exercise may preserve ? cell function in newly diagnosed adults with type 1 diabetes (T1D). However, clinical trials to test this theory require the recruitment and retention of adults with new-onset T1D, which can be challenging. We sought to determine the overall experiences of newly diagnosed adults with T1D in an exercise study, to understand issues that influence the retention of trial participants in such studies.

Design

Qualitative methodology using individual face-to-face (n=6) and telephone interviews (n=14). Interview transcripts were thematically analysed using the framework method.

Setting

The study took place at five participating UK hospitals.

Participants

Twenty participants, aged 19-55 years, in the Exercise for Type 1 Diabetes study were interviewed to explore their study experiences and identify motivators and deterrents towards the study. Participants in control and intervention arms were interviewed, as were people with T1D who had completed (n=16) and withdrawn (n=4).

Results

Participants revealed barriers and facilitators to retention; the majority were generalisable to clinical trials of people with newly diagnosed T1D. Coming to terms with a diagnosis of T1D, lack of time, work pressures, level of health professional support, volume, clarity and consistency of information and feedback and a desire for knowledge about their condition were all cited as influencing factors to trial retention.

Conclusions

To our knowledge, this is the first qualitative study to examine the experience of being involved in an exercise trial by people with T1D. Findings suggest appointments could be shorter, available outside of working hours and planned longer in advance; study information should be clear, consistent and in electronic and paper formats; questionnaires need minimising; healthcare support and feedback needs providing regularly; thought is required around how to support non-exercising arm participants. These considerations may improve participant retention rates in new-onset T1D studies.

SUBMITTER: Henshall C

PROVIDER: S-EPMC6059261 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Qualitative study of barriers to clinical trial retention in adults with recently diagnosed type 1 diabetes.

Henshall Catherine C Narendran Parth P Andrews Robert C RC Daley Amanda A Stokes Keith A KA Kennedy Amy A Greenfield Sheila S

BMJ open 20180717 7

<h4>Objectives</h4>Regular physical exercise may preserve β cell function in newly diagnosed adults with type 1 diabetes (T1D). However, clinical trials to test this theory require the recruitment and retention of adults with new-onset T1D, which can be challenging. We sought to determine the overall experiences of newly diagnosed adults with T1D in an exercise study, to understand issues that influence the retention of trial participants in such studies.<h4>Design</h4>Qualitative methodology us ...[more]

PMID: 30018100

Similar Datasets

Project description:Aims/hypothesisThe aim of this study was to assess whether or not a theory-based behaviour change intervention delivered by trained and quality-assured lifestyle facilitators can achieve and maintain improvements in physical activity, dietary change, medication adherence and smoking cessation in people with recently diagnosed type 2 diabetes.MethodsAn explanatory randomised controlled trial was conducted in 34 general practices in Eastern England (Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen Detected Diabetes in Primary Care-Plus [ADDITION-Plus]). In all, 478 patients meeting eligibility criteria (age 40 to 69 years with recently diagnosed screen or clinically detected diabetes) were individually randomised to receive either intensive treatment (n = 239) or intensive treatment plus a theory-based behaviour change intervention led by a facilitator external to the general practice team (n = 239). Randomisation was central and independent using a partial minimisation procedure to balance stratifiers between treatment arms. Facilitators taught patients skills to facilitate change in and maintenance of key health behaviours, including goal setting, self-monitoring and building habits. Primary outcomes included physical activity energy expenditure (individually calibrated heart rate monitoring and movement sensing), change in objectively measured fruit and vegetable intake (plasma vitamin C), medication adherence (plasma drug levels) and smoking status (plasma cotinine levels) at 1 year. Measurements, data entry and laboratory analysis were conducted with staff unaware of participants' study group allocation.ResultsOf 475 participants still alive, 444 (93%; intervention group 95%, comparison group 92%) attended 1-year follow-up. There were no significant differences between groups in physical activity (difference: +1.50 kJ kg(-1) day(-1); 95% CI -1.74, 4.74), plasma vitamin C (difference: -3.84 μmol/l; 95% CI -8.07, 0.38), smoking (OR 1.37; 95% CI 0.77, 2.43) and plasma drug levels (difference in metformin levels: -119.5 μmol/l; 95% CI -335.0, 95.9). Cardiovascular risk factors and self-reported behaviour improved in both groups with no significant differences between groups.Conclusions/interpretationFor patients with recently diagnosed type 2 diabetes receiving intensive treatment in UK primary care, a facilitator-led individually tailored behaviour change intervention did not improve objectively measured health behaviours or cardiovascular risk factors over 1 year.Trial registrationISRCTN99175498 FUNDING: The trial is supported by the Medical Research Council, the Wellcome Trust, National Health Service R&D support funding (including the Primary Care Research and Diabetes Research Networks) and National Institute of Health Research under its Programme Grants for Applied Research scheme. The Primary Care Unit is supported by NIHR Research funds. Bio-Rad provided equipment for HbA1c testing during the screening phase.

Project description:BackgroundDiabetes self-management education, a universally recommended component of diabetes care, aims to support self-management in people with type 2 diabetes. However, attendance is low (approx. 10%). Previous research investigating the reasons for low attendance have not yet linked findings to theory, making it difficult to translate findings into practice. This study explores why some adults with type 2 diabetes do not attend diabetes self-management education and considers how services can be adapted accordingly, using Andersen's Behavioural Model of Health Service Utilisation as a framework.MethodsA cross-sectional semi-structured qualitative interview study was carried out. Semi-structured interviews were conducted by telephone with 14 adults with type 2 diabetes who had verbally declined their invitation to attend diabetes self-management education in Bath and North East Somerset, UK, within the last 2 years. Data were analysed using inductive thematic analysis before mapping the themes onto the factors of Andersen's Behavioural Model.ResultsTwo main themes were identified: 'perceived need' and 'practical barriers'. The former theme explored participants' tendency to decline diabetes education when they perceived they did not need the programme. This perception tended to arise from participants' high self-efficacy to manage their type 2 diabetes, the low priority they attributed to their condition and limited knowledge about the programme. The latter theme, 'practical barriers', explored the notion that some participants wanted to attend but were unable to due to other commitments and/or transportation issues in getting to the venue.ConclusionsAll sub-themes resonated with one or more factors of Andersen's Behavioural Model indicating that the model may help to elucidate attendance barriers and ways to improve services. To fully understand low attendance to diabetes education, the complex and individualised reasons for non-attendance must be recognised and a person-centred approach should be taken to understand people's experience, needs and capabilities.

Project description:The presence of islet autoantibodies and islet reactive T cells (T+) in adults with established type 2 diabetes (T2D) have been shown to identify those patients with more severe β-cell dysfunction. However, at what stage in the progression toward clinical T2D does islet autoimmunity emerge as an important component influencing β-cell dysfunction? In this ancillary study to the Restoring Insulin SEcretion (RISE) Study, we investigated the prevalence of and association with β-cell dysfunction of T+ and autoantibodies to the 65 kDa glutamic acid decarboxylase antigen (GADA) in obese pre-diabetes adults with impaired glucose tolerance (IGT) and recently diagnosed treatment naïve (Ndx) T2D. We further investigated the effect of 12 months of RISE interventions (metformin or liraglutide plus metformin, or with 3 months of insulin glargine followed by 9 months of metformin or placebo) on islet autoimmune reactivity. We observed GADA(+) in 1.6% of NdxT2D and 4.6% of IGT at baseline, and in 1.6% of NdxT2D and 5.3% of IGT at 12 months, but no significant associations between GADA(+) and β-cell function. T(+) was observed in 50% of NdxT2D and 60.4% of IGT at baseline, and in 68.4% of NdxT2D and 83.9% of IGT at 12 months. T(+) NdxT2D were observed to have significantly higher fasting glucose (p = 0.004), and 2 h glucose (p = 0.0032), but significantly lower steady state C-peptide (sscpep, p = 0.007) compared to T(-) NdxT2D. T(+) IGT participants demonstrated lower but not significant (p = 0.025) acute (first phase) C-peptide response to glucose (ACPRg) compared to T(-) IGT. With metformin treatment, T(+) participants were observed to have a significantly lower Hemoglobin A1c (HbA1c, p = 0.002) and fasting C-peptide (p = 0.002) compared to T(-), whereas T(+) treated with liraglutide + metformin had significantly lower sscpep (p = 0.010) compared to T(-) participants. In the placebo group, T(+) participants demonstrated significantly lower ACPRg (p = 0.001) compared to T(-) participants. In summary, T(+) were found in a large percentage of obese pre-diabetes adults with IGT and in recently diagnosed T2D. Moreover, T(+) were significantly correlated with treatment effects and β-cell dysfunction. Our results demonstrate that T(+) are an important component in T2D.

Dataset Information

Qualitative study of barriers to clinical trial retention in adults with recently diagnosed type 1 diabetes.

Objectives

Design

Setting

Participants

Results

Conclusions

Publications

Qualitative study of barriers to clinical trial retention in adults with recently diagnosed type 1 diabetes.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets