Scaling up: Lessons from a feasibility study involving people with type 2 diabetes and their families

Vivien Coates, Karen McGuigan, Alison Gallagher, Brendan Bunting, Maurice O'Kane, Tracy Donaghy, Geraldine Horigan, Maranna Sweeney

Research output: Contribution to journalMeeting abstractpeer-review

Abstract

Background
The rapid and recent global increase in prevalence of type 2 diabetes (T2D) is of great concern. Although adverse lifestyle behaviours(relating to diet and exercise) are recognised as important risk factors for the development of T2D, interventions at the level of the individ- ual to modify these are challenging. Evidence suggests that lifestyle behaviours are passed through families, from one generation to another. Therefore, when designing T2D interventions, it may be important to consider behaviours developed within the shared family environment.

Aim
To investigate the impact of the shared family environment on risk factors for T2D, and to determine the feasibility of conducting a fully powered study using this methodology.

Design
Cross-sectional feasibility study of index cases diagnosed with T2D and their first degree relatives (siblings and offspring). Index cases were recruited from the diabetes information database (DIAMOND) of a hospital in Northern Ireland.

Method
Sample: The DIAMOND database was screened to identify adults with T2D, aged 45–65 years, with at least two siblings and two offspring, willing to participate in the study. For this feasibility study 50 participants were sought (i.e. 10 index cases each with 4 first degree relatives, spanning two generations). Measures: A range of lifestyle factors, biochemical and clinical markers were collected for all participants. Location of the Study: The rationale underpinning the suitability of this location for the study was based on existing knowledge: 1. As Northern Ireland comprises the most homogenous population group in the UK, it was believed the majority of offspring would live locally; 2. The close family structure encountered in Northern Ireland would lead to strong support for research projects that involve a family member.

Results
Recruitment: Achieving the required sample of n = 50 proved to be impossible over an 18 month recruitment period. For example, dur- ing a four-month screening period, coinciding with a relaxation of in- clusion criteria 434 patients were screened, 85 were found to be eligible for inclusion, with only 6 successfully recruited. Only 8 index cases were secured across the study duration.
Support: Family support structures were found to be weak, with a number of eligible candidates reporting strained family relationships as a deterrent to participation.
Family size: Many potential index cases did not have enough siblings and/or children required to participate.
Motivation: Index cases lacked motivation, both in relation to their condition and willingness to participate.
Age: The tight inclusion criteria for age of index cases (45–65 years) were found to be restrictive.
Data analysis: This proved difficult due to the small sample size and the clustering of family data.
Conclusion
The feasibility study provided key insights, impacting on scaling up decisions. We now know that identifying index cases for this study through a hospital data base is ineffective and would be better suited to a primary care setting. The data gathering methods and instruments worked effectively. In light of the difficulties encountered in the feasibility study, it was agreed that a fully powered study would not be developed.
Original languageEnglish
JournalTrials
Volume18
Issue numberS1
DOIs
Publication statusPublished - 10 May 2017

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