A randomised controlled trial of a patient based Diabetes REcall And Management system: the DREAM Trial

ISRCTN ISRCTN32042030
DOI https://doi.org/10.1186/ISRCTN32042030
Protocol serial number N/A
Sponsor University of Newcastle upon Tyne (UK)
Funders Diabetes UK (UK) (ref: BDA:RD01/0002155NHS), Executive Northern & Yorkshire Regional R&D Programme NYRO ACJ (UK) (March 2000)
Submission date
11/02/2002
Registration date
11/02/2002
Last edited
13/04/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Martin Eccles
Scientific

Centre for Health Services Research
University of Newcastle upon Tyne
21 Claremont Place
Newcastle upon Tyne
NE2 4AA
United Kingdom

Phone +44 (0)191 222 8674
Email martin.eccles@ncl.ac.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study acronymDREAM trial
Study objectivesTo evaluate the effectiveness and efficiency of an area wide computerised structured recall and management system for adults with diabetes.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedDiabetes
Intervention1. 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
Intervention typeOther
Primary outcome measure(s)

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).

Key secondary outcome measure(s)

No secondary outcome measures

Completion date31/01/2003

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration7500
Key inclusion criteriaPeople 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)
Key exclusion criteriaDoes not comply with the above inclusion criteria.
Date of first enrolment01/01/2001
Date of final enrolment31/01/2003

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Centre for Health Services Research
Newcastle upon Tyne
NE2 4AA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2010 Yes No
Protocol article protocol 21/03/2002 Yes No
Study website Study website 11/11/2025 11/11/2025 No Yes