Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
19/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

  2. 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.

Additional files

Editorial Notes