Background: This paper presents the pilot study and protocol for a randomised controlled trial to test the effectiveness of a psychological, family-based intervention to improve outcomes in those with poorly controlled type 2 diabetes. The intervention has been designed to change the illness perceptions of patients with poorly controlled type 2 diabetes, and their family members. It is a complex psychological intervention, developed from the Self-Regulatory Model of Illness Behaviour. The important influence the family context can have in psychological interventions and diabetes management is also recognised, by the inclusion of patients' family members.
Methods/design: We aim to recruit 122 patients with persistently poorly controlled diabetes. Patients are deemed to have persistent poor control when at least two out of their last three HbA1c readings are 8.0% or over. Patients nominate a family member to participate with them, and this patient/family member dyad is randomly allocated to either the intervention or control group. Participants in the control group receive their usual care. Participants in the intervention group participate, with their family members, in three intervention sessions. Sessions one and two are delivered in the participant's home by a health psychologist. Session one takes place approximately one week after session two, with the third session, a follow-up telephone call, one week later. The intervention is based upon clarifying the illness perceptions of both the patient and the family member, examining how they influence self-management behaviours, improving the degree of similarity of patient and family member perceptions in a positive direction and developing personalized action plans to improve diabetes management.
Discussion: This study is the first of its kind to incorporate the evidence from illness perceptions research into developing and applying an intervention for people with poorly controlled diabetes and their families. This study also acknowledges the important role of family members in effective diabetes care.
Trial registration: ISRCTN62219234.