JMIR Publications

ABSTRACT

Background:

‘HeLP-Diabetes’ is a digital self-management intervention for people with type 2 diabetes mellitus (T2DM), which was effective in reducing HbA1c in a randomised controlled trial (RCT). NHS England have since commissioned a national roll-out of a modified version of HeLP-Diabetes into routine care (now called ‘Healthy Living’). Healthy Living presents a unique opportunity to study the real-world implementation of an intervention developed and tested in a clinical trial setting, providing insights into how future digital interventions can maintain fidelity as they are scaled up.

Objective:

Objectives of this research were to: (1) describe Healthy Living in terms of behaviour change techniques (BCTs), self-management tasks and features of intervention delivery; (2) compare the fidelity of these aspects with the HeLP-Diabetes intervention; and (3) explain the reasons for any fidelity drift during national rollout.

Methods:

This study used mixed methods. A content analysis of Healthy Living was conducted using three coding frameworks: (a) BCT Taxonomy v1; (b) a new coding framework the authors developed for assessing self-management tasks; and (c) Template for Intervention Description and Replication (TIDieR). The extent to which BCTs and self-management tasks were included in Healthy Living was derived and compared with published descriptions of HeLP-Diabetes. One-to-one semi-structured interviews were conducted with nine key stakeholders involved in the development of HeLP-Diabetes or Healthy Living to understand the reasons for any changes during national rollout. Qualitative data were thematically analysed using a modified framework approach.

Results:

There were 43 BCTs identified in Healthy Living. Healthy Living included all but one of the self-regulatory BCTs (‘commitment’) in the original HeLP-Diabetes intervention, including goal setting, self-monitoring and problem solving. Healthy Living addressed all areas of self-management: medical, emotional and role management. Two important changes to features of delivery were identified. First, facilitated access from a healthcare professional was not implemented because general practices had fewer resources available in comparison with the RCT. Second, Healthy Living included an additional structured online learning curriculum that was later developed by the HeLP-Diabetes team, but was not included in the HeLP-Diabetes intervention tested in the RCT. This was because of changes in NHS policy that encouraged referral to structured education. Interviewees described how the service provider had to substantially reformat the content of the original HeLP-Diabetes website to make it more usable and accessible to meet digital standards.

Conclusions:

The national roll-out of Healthy Living had good fidelity to the BCT and self-management content of HeLP-Diabetes. Important changes were attributable to the challenges of scaling up a digital intervention from an RCT into a nationally implemented intervention, highlighting the importance of considering implementation at earlier phases of intervention development. Future development and implementation of digital interventions would benefit from greater multisectoral collaboration from the outset.