Overcoming psychological stress to injection for type2 diabetes. A RCT
Research type
Research Study
Full title
Impact of structured education on psychological stress to overcome a barrier to injectable treatment for type 2 diabetes. A randomised controlled trial.
IRAS ID
156708
Contact name
Alyson Hill
Contact email
Sponsor organisation
Ulster University
ISRCTN Number
ISRCTN16710901
Duration of Study in the UK
2 years, 4 months, 1 days
Research summary
Many people with type 2 diabetes will eventually require injection treatment due to the progressive nature of diabetes. There is strong evidence to suggest that good control of blood sugar levels reduces the long term risk of diabetes complications. The prospect of starting injection treatment causes psychological stress [a barrier] in many patients which may result in reluctance [and in some cases delay] to commencing it. Our study will investigate whether structured education delivered in advance of commencing injection treatment reduces psychological stress. A two phase study is proposed. Phase 1: Patients who have recently commenced injection treatment will be invited to participate in focus groups. These discussions will identify common themes and be used to inform the development of a structured education programme. A review of records in the Diabetes Clinic Database will identify the current practice in commencing injection treatment. Phase 2: The structured education programme will be tested and refined in an initial feasibility study on a small group of patients who are planning to commence injection treatment. The effectiveness of the refined structured education programme [SEP] in reducing psychological stress will then be compared in a larger study in which patients will be randomised to receive either usual clinical care or usual clinical care in conjunction with SEP. Psychological stress will be measured in both groups using validated questionnaires. Standard clinical measurements including blood glucose tests, dietary intake and diabetes self-management will be assessed to evaluate the impact of this education programme.
REC name
HSC REC A
REC reference
15/NI/0091
Date of REC Opinion
29 May 2015
REC opinion
Favourable Opinion