The Study of Health trainers Improving Patient Self management support

ISRCTN	ISRCTN08022935
DOI	https://doi.org/10.1186/ISRCTN08022935
Secondary identifying numbers	10855

Submission date: 16/01/2012
Registration date: 16/01/2012
Last edited: 24/08/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Diabetes mellitus (DM) is a common disorder that affects around 2.3 million people in the UK. DM control is linked with peoples understanding of DM and self-management. Evaluation of the local (Blackpool) X-PERT diabetes education programme suggests that there remain gaps in provision for people from disadvantaged communities with low literacy and numeracy levels.
We plan to use Health Trainers (HTs) to improve engagement with supported self-management in people with type 2 DM by developing individually tailored management plans based on patients priorities and locally available options, with ongoing HT support over six months.
HTs are a Government initiative designed to reduce health inequalities. They are trained to help patients change behaviours based on psychological and behavioural theories; they have not been used specifically with patients with diabetes. Interventions aimed at improving provisions for marginalised populations need to be tested, and often are not.
The purpose of this study is to see if people with diabetes find HTs useful in helping them to live healthily with their diabetes.

Who can participate?
Patients over 18 years of age, on the practice register for DM, and whose diabetes is currently poorly controlled (as measured by routine blood tests undertaken by their practice) will be eligible to participate.

What does the study involve?
Patients who agree to take part in this study will be contacted by a researcher from Keele University who will arrange to visit them (at home or in the surgery) to explain the study, answer any questions, obtain written consent, and then ask some baseline questions. Questions will be asked by the researcher and the patients answers entered directly into a database by the researcher (using face-to-face data collection ensures patients with low basic skills are not excluded).
Patients will then be randomly assigned to either the intervention group or to continue with usual general practitioner care. Patients in the intervention group will be contacted by the HT who will arrange an appointment to see him/her. At this meeting the patient and the health trainer will develop an individually tailored self-management plan according to patient priorities and goals. He/she will arrange further contact either face-to-face or by telephone on two or more occasions over the following six months.
The researcher will contact the patient again about seven months after her first visit and arrange to visit or telephone to collect follow-up questionnaire data.

What are the possible benefits and risks of participating?
Having a healthy lifestyle is very important when you have diabetes. It is not always easy to manage to have a healthy lifestyle HTs, although not medically qualified, do understand the challenges in achieving a healthy way of life. They are trained in helping people to achieve their goals.
There are no risks associated with seeing a HT.

Where is the study run from?
Keele University, UK.

When is the study starting and how long is it expected to run for?
The study will start to recruit patients in March 2012 and will run until July 2013.

Who is funding the study?
National Institute of Health Research (NIHR) (UK).

Who is the main contact?
Dr Joanne Protheroe, PI
Ms Shirley Caldwell, study coordinator
j.gray@cphc.keele.ac.uk

Contact information

Ms Jacqueline Gray
Scientific

Arthritis Research UK Primary Care Centre
Primary Care Sciences
Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom

Email	j.gray@cphc.keele.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Process of Care
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A pilot study to examine the feasibility of improving engagement with supported self-management in diabetic patients in disadvantaged populations
Study acronym	SHIPs
Study objectives	Diabetes Mellitus (DM) is a common disorder that affects 2.3 million UK people. DM control is linked with peoples understanding of DM & self-management. We plan to use Health Trainers (HTs) to improve engagement with supported self-management in people with type 2 DM by developing individually tailored management plans based on patients priorities & locally available options, with ongoing HT support over 6 months. This study is a pilot randomised controlled trial (RCT) of the HT intervention vs usual general practitioner (GP) care; recruited patients will be randomised to see the HT or continue with usual GP care. The project is in NHS Blackpool which has high levels of DM & low levels of basic skills. Type 2 DM (85% of DM) is linked with obesity & lifestyle. 1. We will conduct interviews with Patients, HTs and GPs to refine the intervention 2. Evaluate the intervention through a pilot trial (using face to face data collection to ensure patients with low basic skills are not excluded) & qualitative interviews 3. Collect basic cost evaluation data outcomes. We will compare the intervention with usual care. Outcome measures will include diabetes self-care behaviours, self-efficacy, glucose control & quality of life.The potential impact will be better DM self-management & health in people with type 2 DM, patients empowered to take more control of their health, a potential role for HTs to support people with type 2 DM and reduced health care costs. Please note that as of 15/03/2013, the anticipated end date for this trial was updated from 30/09/2013 to 31/07/2013
Ethics approval(s)	NRES Committee East Midlands - Derby 2; First MREC approval date 16/08/2011, ref: 11/EM/0294
Health condition(s) or problem(s) studied	Topic: Diabetes Research Network, Primary Care Research Network for England; Subtopic: Type 2, Not Assigned; Disease: Diabetic Control, All Diseases, Education
Intervention	Structured interview: The intervention is a structured interview with the Health Trainer to develop an individualised patient self managment plan utilising a locally developed menu of options. The HT will follow up 1-2 times either face to face or by telephone depending on patient preference over following 6 months.; Follow Up Length: 7 month(s); Study Entry : Registration only
Intervention type	Other
Primary outcome measure	Diabetes Self Care Activities Measure (DSCAM); Timepoint(s): Baseline and 7 months follow up (FU)
Secondary outcome measures	1. Demographic information 1.1. Age; Timepoint(s): Baseline 1.2. Education; Timepoint(s): Baseline 1.3. Ethnicity; Timepoint(s): Baseline 1.4. Sex; Timepoint(s): Baseline 2. Depression using QOF screening questions; Timepoint(s): Baseline and 7 months FU 3. Health economic information-health service use; Timepoint(s): Baseline and 7 months FU 4. Health Status - SF12; Timepoint(s): Baseline and 7 months FU 5. Health-related Quality of Life; Timepoint(s): Baseline and 7 months FU 6. Length of time since diagnosis.; Timepoint(s): Baseline 7. Self-efficacy and Illness Perception Questionnaires; Timepoint(s): Baseline and 7 months FU 8. Socio-economic information 8.1. Employment status; Timepoint(s): Baseline 8.2. Housing; Timepoint(s): Baseline 8.3. Receipt of benefits; Timepoint(s): Baseline 9. Tests of Health Literacy; Timepoint(s): Baseline
Overall study start date	01/03/2012
Completion date	31/07/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 120; UK Sample Size: 120
Key inclusion criteria	1. Adult patients >18yrs with poorly controlled type 2 DM (defined as having an HbA1c greater than 7.5 at their last two measurements 2. Target Gender: Male & Female; Upper Age Limit 110 no age limit or unit specified ; Lower Age Limit 18 no age limit or unit specified
Key exclusion criteria	1. Patients deemed ineligible for the study by practice staff 1.1. Include patients with terminal illness 1.2. Those unable to participate due to deafness, blindness or cognitive dysfuncton
Date of first enrolment	01/03/2012
Date of final enrolment	31/07/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Arthritis Research UK Primary Care Centre

Newcastle-Under-Lyme
ST5 5BG
United Kingdom

Sponsor information

Keele University (UK)
University/education

Keele
Newcastle
ST5 5BG
England
United Kingdom

"ROR"	https://ror.org/00340yn33

Funders

Funder type

Government

National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit Programme (RfPB)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

24/08/2016: No publications found, verifying study status with principal investigator