Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
RP/2005/178
Study information
Scientific title
Changing illness perceptions: a randomised controlled trial of a psychological, family-based intervention to improve outcomes in type 2 diabetes
Acronym
Study hypothesis
To examine the effects of a psychological, family-based intervention to improve biophysical, psychosocial and behavioural outcomes for patients with poorly controlled type 2 diabetes.
Ethics approval(s)
The Joint Research Ethics Committee of St. James's Hospital and the Federated Dublin Voluntary Hospitals, approved on the 8th February 2006.
Study design
This study is a randomised controlled trial with an intervention group and a control group.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Not Specified
Patient information sheet
Condition
Type 2 diabetes
Intervention
The study is a psychological intervention, designed to change peoples cognitions about their diabetes, with a view to improving diabetes self-management behaviours, and ultimately diabetes outcomes. The intervention is aimed at changing any negative or misperceptions about diabetes, and improving, in a positive direction, the degree of similarity between patient and family members cognitions in relation to diabetes.
The intervention will be delivered by a health psychologist who is trained in using motivational interviewing techniques. The intervention also incorporates a family member of the person with diabetes, and will also focus on the family members cognitions about diabetes. The participants in the control group receive the usual care.
The intervention will be delivered over three sessions, one session a week. Participants will be followed up at 6 months from time of randomisation.
Intervention type
Other
Primary outcome measure
Primary outcomes will be collected at baseline and at 6-month follow up.
1. HbA1c
2. Illness perceptions
3. Psychological well-being
Secondary outcome measures
Secondary measures will be collected at baseline and at 6-month follow up.
1. Biomedical outcomes
a. Blood pressure
b. Body mass index
c. Cholesterol
2. Diabetes self-efficacy
3. Social support
4. Daily activities
5. Self-care activities
Overall study start date
01/04/2006
Overall study end date
30/03/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Have type 2 diabetes for more than one year, and at least two out of their last three HbA1c readings have been 8.0% or over, in order to identify patients with persistent poor control
2. Over 18 years of age
3. Have fluency in English
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Not Specified
Target number of participants
122
Total final enrolment
121
Participant exclusion criteria
Patients with a significant mental or physical illness, as determined by the patients clinician, will be excluded. Significant mental or physical illness is defined as any illness that is thought likely to impair the patients capacity to change their lifestyle behaviour or assimilate new information.
Recruitment start date
01/04/2006
Recruitment end date
30/03/2009
Locations
Countries of recruitment
Ireland
Study participating centre
Department of Public Health and Primary Care
Dublin 24
-
Ireland
Sponsor information
Organisation
Health Research Board (Ireland)
Sponsor details
73 Lower Baggot Street
Dublin 2
-
Ireland
Sponsor type
Government
Website
ROR
Funders
Funder type
Government
Funder name
Health Research Board, Research Project Grant - General 2005 (RP/2005/178) (Ireland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 27/06/2007 | Yes | No | |
| Results article | results | 01/02/2011 | 16/05/2019 | Yes | No |