The purpose of this article is to share insights from the National Institute for Health and Care Research Clinical Research Network (NIHR CRN) in delivering research for Multiple Long Term Conditions (MLTC) and to highlight lessons of wider relevance across the research ecosystem.
Designing health and care systems to be more responsive to the needs of people living with MLTC requires a considerable evidence base. When compared with research focused on a single disease area, research relating to MLTC raises unique considerations at the stages of planning, placing, and delivering research studies. Our article describes challenges associated with MLTC research outcomes and outlines different types of interventions to target MLTC, along with related research delivery considerations. Our article also raises important considerations for placing research in the most appropriate setting and highlights the vital role of robust feasibility studies, informed by the lived experience of patients and carers with MLTC, for ensuring that studies are conducted, recruited to, and completed in a timely and appropriate way.
Increasing the evidence base for the prevention and management of MLTC is a necessity for our health and care system. This presents novel challenges that require collaboration between multiple stakeholders. The UK benefits from a unique research infrastructure, including support for the stages of planning and delivery of health and care research. As the health and care system moves towards bringing care closer to patients and service users, the appropriate selection of the health and care settings and research sites in which to deliver MLTC research, in addition to understanding and removing barriers to recruitment and participation for people with MLTCs, are important considerations to enable us to collectively respond to this challenge.
To identify the minimum effective dose of a multi-behaviour change technique (BCT) intervention to increase physical activity among individuals on primary statin therapy using the time-to-event continual reassessment method (TiTE-CRM).
A large New York metropolitan area healthcare system comprising approximately 85 000 employees and 5.5 million patient encounters annually.
42 participants enrolled in 13 cohorts of 3 participants, 1 cohort of 2 participants and 1 cohort of 1 participant. The sample was composed of 16.7% individuals aged 66 and older (n=7), 64.3% women (n=27), 69.0% white individuals (n=29) and 7.1% Hispanic individuals (n=3).
A variable-duration, four-BCT text message intervention and a 2-week follow-up. Dose assignment relied on TiTE-CRM to adjust the duration of the intervention based on adherence of participants in prior cohorts. Five mechanisms of action (MoAs) were assessed: self-efficacy, intrinsic regulation, discrepancy in behaviour, motivation and barriers to activity.
The primary outcome measure was the proportion of participants who achieved a 2000 step/day increase between baseline and follow-up. The secondary outcomes were within-participant changes in daily steps (examined as a continuous variable at the daily level) and potential MoAs for increased physical activity.
Of the 40 participants who completed follow-up, 7 (17.5%) achieved the goal of 2000 or more steps per day during their follow-up period. Though participants did increase the number of steps they walked during the intervention (B(SE)=373.1 (154.7) steps; p=0.016), there was no association between increased intervention duration and increased daily average steps. The intervention was also associated with increases in self-efficacy (p=0.002), intrinsic regulation (p=0.037), discrepancy in behaviour (p
The results of this trial did not show a traditional dose-response curve to increasing the length of a multicomponent BCT intervention. Results did show that the intervention successfully increased steps during the intervention period and that the benefit of the intervention dwindled during follow-up. Further, potential MoAs for the intervention were confirmed.