A study protocol for a feasibility trial of telephone-delivered adherence therapy for adults with type 2 diabetes

Abstract

Aims: Adherence therapy is a candidate intervention to improve medication adherence and clinical outcomes in patients with type 2 diabetes. The feasibility of conducting a trial of adherence therapy in this population has not been established. The objective of this study is therefore to test the feasibility of conducting a randomized controlled trial of adherence therapy in a Middle Eastern context. Design: A single-centre randomized controlled feasibility trial of adherence therapy in patients with type 2 diabetes. Methods: We will undertake an initial cultural adaptation of a telephone-delivered form of adherence therapy in four patients in a Middle Eastern context. Our subsequent feasibility trial will aim to recruit 40 non-adherent diabetic patients that will be randomly allocated to receive eight weekly 30-min telephone adherence therapy sessions delivered by a diabetes educator versus treatment as usual. Key outcomes of interest include the number of patients invited to take part in the trial that consent to participate and then go on to complete treatment. Result: The findings of this study will determine the feasibility of undertaking a full randomized controlled trial of adherence therapy in patients with type 2 diabetes.