SHIPS

SHIPS

Chief Investigator: 

Dr Joanne Protheroe

Co-applicants:

Study Co-ordinator:

Kendra Cooke

Funder name / reference n^o:

NIHR Research for Patient Benefit / PB-PG-0909-20033

MREC number:

11/EM/0294

ISRCTN:

ISRCTN08022935

UKCRN Study portfolio:

10855

Reporting stage

Summary of trial:

Study design:

A pilot randomised controlled trial to examine the feasibility of improving engagement with supported self-management in type 2 diabetic patients in disadvantaged populations.

120 patients with poorly controlled diabetes mellitus were il randomised on a 1:1 basis to either a structured interview with a health trainer (HT) for the purpose of developing an individually tailored self-management plan or to usual standard care.

Baseline data was collected in face-to-face interviews with a researcher entering questionnaire data directly onto a computer. Follow up questionnaire data was collected over the telephone at 7 months.

Primary objective:

To refine the intervention, test out and develop methods to maximise recruitment and data collection, gather preliminary evidence that the intervention is effective with this population and collect pilot data to allow sample size estimation for a full-scale RCT. 

Interventions:

The intervention consists of a structured interview with the HT and development of an individualised patient self-management plan, plus up to three two-monthly support phone calls from the HT (dependant on agreements  between the patient and the HT) for a maximum of 6 months