Contact information
Type
Scientific
Primary contact
Dr Rebecca Lawton
ORCID ID
Contact details
University of Leeds
School of Psychology
Leeds
LS2 9TJ
United Kingdom
+44 (0)113 343 5715
r.j.lawton@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RRCC218LG
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/10/2001
Overall trial end date
31/10/2003
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
370
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2001
Recruitment end date
31/10/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Leeds
Leeds
LS2 9TJ
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (UK)
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
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Study 1: 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15748685
Study 2: 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/15993559
Publication citations
-
Jackson C, Lawton R, Knapp P, Raynor DK, Conner M, Lowe C, Closs SJ, Beyond intention: do specific plans increase health behaviours in patients in primary care? A study of fruit and vegetable consumption., Soc Sci Med, 2005, 60, 10, 2383-2391, doi: 10.1016/j.socscimed.2004.10.014.
-
Jackson C, Lawton RJ, Raynor DK, Knapp P, Conner MT, Lowe CJ, Closs SJ, Promoting adherence to antibiotics: a test of implementation intentions., Patient Educ Couns, 2006, 61, 2, 212-218, doi: 10.1016/j.pec.2005.03.010.