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ISRCTN
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ISRCTN32042030
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of a patient based Diabetes REcall And Management system: the DREAM Trial
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Scientific title
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Acronym
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DREAM trial
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Serial number at source
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N/A
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Study hypothesis
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To evaluate the effectiveness and efficiency of an area wide computerised structured recall and management system for adults with diabetes.
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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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Diabetes
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Participants - inclusion criteria
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People with diabetes aged 18 and over (N.B.: A cluster randomised trial therefore unit of randomisation and analysis is the GP practice not the patient)
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Participants - exclusion criteria
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Does not comply with the above inclusion criteria.
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Anticipated start date
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01/01/2001
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Anticipated end date
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31/01/2003
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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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7500
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Interventions
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1. Locally adapted evidence based guidelines for the management and follow up of patients with diabetes
2. Automated prompts to patients and primary care clinicians that a review consultation is necessary
3. A structured management sheet (including patient specific management suggestions based on [1])
4. An enhanced monitoring system to follow up reasons for non-attendance from both patients and clinicians and to re-schedule appointments, based on non-return of a completed management sheet
5. Patient feedback for patients in primary care
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Primary outcome measure(s)
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The main study outcome measures will be rates of performance of process of care and the patient based measures of functional and psychosocial wellbeing. Process of care variables will be collected via the computerised database. The exact data to be collected will be determined by both the current content of the database and the guidelines but will include such data items as rates of attendance at clinics and annual reviews, conduct of eye and feet examinations, performance of investigations and prescribing. We will also collect data on clinical measures (e.g. HbA1c, and blood pressure levels).
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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1. Diabetes UK (UK) (ref: BDA:RD01/0002155NHS)
2. Executive Northern & Yorkshire Regional R&D Programme NYRO ACJ (UK) (March 2000)
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Trial website
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http://www.ncl.ac.uk/pahs/research/services/practice/dream.htm
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Publications
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Protocol in http://www.ncbi.nlm.nih.gov/pubmed/11914161
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Contact name
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Professor
Martin
Eccles
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Address
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Centre for Health Services Research
University of Newcastle upon Tyne
21 Claremont Place
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City/town
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Newcastle upon Tyne
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Zip/Postcode
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NE2 4AA
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Country
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United Kingdom
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Tel
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+44 (0)191 222 8674
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Fax
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+44 (0)191 222 6043
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Email
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martin.eccles@ncl.ac.uk
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Sponsor
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University of Newcastle upon Tyne (UK)
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Address
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Centre for Health Services Research
21 Claremont Place
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City/town
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Newcastle upon Tyne
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Zip/Postcode
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NE2 4AA
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Country
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United Kingdom
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Sponsor website:
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http://www.ncl.ac.uk/
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Date applied
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11/02/2002
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Last edited
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19/02/2008
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Date ISRCTN assigned
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11/02/2002
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