Process evaluation of the HARPdoc trial (PE-HARPdoc)
Research type
Research Study
Full title
Process evaluation of the clinical trial testing the Hypoglycaemia Awareness Restoration Programme for people with type 1 diabetes and problematic hypoglycaemia persisting despite optimised self-care (HARPdoc)
IRAS ID
240752
Contact name
Nick Sevdalis
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
1 years, 5 months, 29 days
Research summary
[What?] Current study represents process evaluation of a registered clinical trial, namely, HARPdoc (ClinicalTrials.gov: NCT02940873). The trial is designed to test two structured education programmes focused on the management of hypoglycaemia and severe hypoglycaemia in patients with type 1 diabetes who are continuing to experience problems despite optimised self-management.
[Why?] The aim of the process evaluation of the HARPdoc trial is to assess the way in which the programmes are delivered in the context of the local study centres, and gain better understanding of the link between the delivery of the programmes and the expected improvements in the study endpoints (reduction in hypoglycaemia events). This is important because it will enable development of a manual and specific implementation strategies for the post-trial scale-up of an effective programme, so that it becomes more readily available to those individuals with type 1 diabetes who are continuing to experience hypoglycaemia despite optimise self-managment.
[Who?] Participants for the process evaluation are the stakeholders of the programmes offered as part of the HARPdoc trial. They encompass individuals with type 1 diabetes who are eligible and have either declined, partly completed, or fully completed the trial's interventions/courses. Participants also include the diabetes care teams, including health educators, physicians, clinical psychologists, and administrative support. Lastly, the prospective referrers and commissioners will be recruited as well.
[How?] Process evaluation participants will be given a short survey and will be interviewed (30-60min) at 2 time points: within 3 months of course completion and again at 12 months post-completion. In addition, trial records, such as outcome data, as well as audio recordings of the individual programmes, and trial meeting minutes will be analysed.
[Where?] Interviews will be conducted via phone or home/site visits. Surveys will be distributed in two ways: electronically and via post.
REC name
London - Harrow Research Ethics Committee
REC reference
18/LO/1020
Date of REC Opinion
19 Jul 2018
REC opinion
Further Information Favourable Opinion