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ISRCTN
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ISRCTN29760311
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ClinicalTrials.gov identifier
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Public title
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Bridging the intention-behaviour gap: promoting compliance with medication for coronary heart disease
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Scientific title
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Acronym
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N/A
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Serial number at source
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RRCC218LG
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Study hypothesis
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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.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular diseases: Heart disease
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/10/2001
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Anticipated end date
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31/10/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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370
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Interventions
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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.
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Primary outcome measure(s)
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Study 1: Daily fruit and vegetable consumption (self-report and 24-hour recall)
Study 2: Adherence to antibiotics (self-report and pill count)
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NHS Executive Northern and Yorkshire (UK)
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Trial website
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Publications
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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
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Contact name
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Dr
Rebecca
Lawton
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Address
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University of Leeds
School of Psychology
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City/town
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Leeds
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Zip/Postcode
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LS2 9TJ
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Country
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United Kingdom
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Tel
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+44 (0)113 343 5715
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Fax
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+44 (0)113 343 5749
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Email
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r.j.lawton@leeds.ac.uk
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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19/10/2011
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Date ISRCTN assigned
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23/01/2004
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