Bridging the intention-behaviour gap: promoting compliance with medication for coronary heart disease
| ISRCTN | ISRCTN29760311 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29760311 |
| Secondary identifying numbers | RRCC218LG |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 19/10/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Rebecca Lawton
Scientific
Scientific
University of Leeds
School of Psychology
Leeds
LS2 9TJ
United Kingdom
| Phone | +44 (0)113 343 5715 |
|---|---|
| r.j.lawton@leeds.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To test whether: implementation intention strategies increase three-month compliance to prescribed medicines among patients in primary care compared to those control group patients using their usual strategies. Do implementation intentions increase adherence to medication prescribed for coronary heart disease? N.B. The pilot study revealed problems with recruiting non-adherent participants. Two alternative studies were, therefore, administered. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular diseases: Heart disease |
| Intervention | Both studies were randomly controlled trials: Study 1: 120 cardiac patients were recruited and randomised into three groups (control, Theory of Planned Behaviour (TPB) questionnaire only, TPB questionnaire + formed implementation intention). They were telephoned at 7, 28 and 90 days post-recruitment. Fruit and vegetable consumption was recorded at recruitment and at each of the follow-up time points. 97 participants completed the study. Study 2: 249 patients presenting with a prescription for antibiotics were recruited and randomised into four groups (control, TPB questionnaire only, TPB questionnaire + formed own implementation intention, TPB questionnaire + researcher provided implementation intention). They were telephoned on the day after their antibiotics were due to be completed to record their adherence to the medication. A fifth group of participants was recruited who only received the follow-up telephone call. 241participants completed the study. |
| Intervention type | Other |
| Primary outcome measure | Study 1: Daily fruit and vegetable consumption (self-report and 24-hour recall) Study 2: Adherence to antibiotics (self-report and pill count) |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/2001 |
| Completion date | 31/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 370 |
| Key inclusion criteria | Study 1: Patients attending a secondary prevention CHD clinic in primary care Study 2: Patients presenting to a pharmacy with a prescription for an antibiotic |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/2001 |
| Date of final enrolment | 31/10/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Leeds
Leeds
LS2 9TJ
United Kingdom
LS2 9TJ
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (UK)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Study 1: results | 01/05/2005 | Yes | No | |
| Results article | Study 2: results | 01/05/2006 | Yes | No |
