Changing illness perceptions: a randomised controlled trial of a psychological, family-based intervention to improve outcomes in type 2 diabetes
| ISRCTN | ISRCTN62219234 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62219234 |
| Protocol serial number | RP/2005/178 |
| Sponsor | Health Research Board (Ireland) |
| Funder | Health Research Board, Research Project Grant - General 2005 (RP/2005/178) (Ireland) |
- Submission date
- 28/02/2007
- Registration date
- 27/04/2007
- Last edited
- 16/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Susan Smith
Scientific
Scientific
Department of Public Health and Primary Care
Trinity Centre for Health Sciences
AMiNCH
Tallaght
Dublin 24
-
Ireland
Study information
| Primary study design | Interventional |
|---|---|
| Study design | This study is a randomised controlled trial with an intervention group and a control group. |
| Secondary study design | Randomised controlled trial |
| Scientific title | Changing illness perceptions: a randomised controlled trial of a psychological, family-based intervention to improve outcomes in type 2 diabetes |
| Study objectives | 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. |
| Health condition(s) or problem(s) studied | 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(s) |
Primary outcomes will be collected at baseline and at 6-month follow up. |
| Key secondary outcome measure(s) |
Secondary measures will be collected at baseline and at 6-month follow up. |
| Completion date | 30/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 122 |
| Total final enrolment | 121 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/04/2006 |
| Date of final enrolment | 30/03/2009 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Department of Public Health and Primary Care
Dublin 24
-
Ireland
-
Ireland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2011 | 16/05/2019 | Yes | No |
| Protocol article | protocol | 27/06/2007 | Yes | No |
Editorial Notes
16/05/2019: Publication reference and total final enrolment added.
