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ISRCTN
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ISRCTN70666174
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ClinicalTrials.gov identifier
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Public title
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A Randomised Controlled Trial of goal setting and pacing for cardiac patients not suitable for group based cardiac rehabilitation
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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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RRCC860F WATHALL
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Study hypothesis
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A Randomised Control Trial of goal setting and pacing for cardiac patients not suitable for group based cardiac rehabilitation.
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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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Coronary care patients
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Participants - exclusion criteria
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Patients who would normally be offered rehabilitation classes
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Anticipated start date
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08/01/2000
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Anticipated end date
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03/01/2003
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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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Not provided at time of registration
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Interventions
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i. Goal-setting and pacing
ii. Standard care
iii. Attention control procedure
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Primary outcome measure(s)
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The primary outcome will be an increase in fitness measured in (METS) using a standardised exercise test. The patients will also keep an activity diary. Other variables to be measured will include anxiety and depression (Hospital Anxiety and Depression Scale), health beliefs (Illness Perception Questionnaire) this questionnaire has been shown to predict a number of aspects of recovery in post MI patients, medical co morbidity the number of acute events (inc, hospital admissions), the number of consultations for cardiac reasons, risk factor profile a cumulative secondary prevention score (using method of ASPIRE group), systolic and diastolic blood pressure at rest and following exercise and the EuroQU0L, a measure of health related quality of life. All of these measures have been validated for use in this patient group and will be piloted during Phase 1 for suitability when other measures may be added.
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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
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Trial website
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Publications
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Contact name
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Mr
P B
Wathall
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Address
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94 Huntington Road
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City/town
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York
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Zip/Postcode
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YO31 8RP
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Country
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United Kingdom
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Tel
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+44 01904 640246
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Fax
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+44
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Email
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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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21/11/2005
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Date ISRCTN assigned
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23/01/2004
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