Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/02/2002
Date assigned
11/02/2002
Last edited
13/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ncl.ac.uk/pahs/research/services/practice/dream.htm

Contact information

Type

Scientific

Primary contact

Professor Martin Eccles

ORCID ID

Contact details

Centre for Health Services Research
University of Newcastle upon Tyne
21 Claremont Place
Newcastle upon Tyne
NE2 4AA
United Kingdom
+44 (0)191 222 8674
martin.eccles@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

DREAM trial

Study hypothesis

To evaluate the effectiveness and efficiency of an area wide computerised structured recall and management system for adults with diabetes.

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

Quality of life

Patient information sheet

Condition

Diabetes

Intervention

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

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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).

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/01/2001

Overall trial end date

31/01/2003

Reason abandoned

Eligibility

Participant inclusion criteria

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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

7500

Participant exclusion criteria

Does not comply with the above inclusion criteria.

Recruitment start date

01/01/2001

Recruitment end date

31/01/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University of Newcastle upon Tyne (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.ncl.ac.uk/

Funders

Funder type

University/education

Funder name

Diabetes UK (UK) (ref: BDA:RD01/0002155NHS)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Executive Northern & Yorkshire Regional R&D Programme NYRO ACJ (UK) (March 2000)

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

1. 2002 protocol in http://www.ncbi.nlm.nih.gov/pubmed/11914161
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20009095

Publication citations

  1. Protocol

    Eccles M, Hawthorne G, Whitty P, Steen N, Vanoli A, Grimshaw J, Wood L, A randomised controlled trial of a patient based Diabetes Recall and Management System: the DREAM trial: a study protocol [ISRCTN32042030]., BMC Health Serv Res, 2002, 2, 1, 5.

  2. Results

    Hanley AJ, Zinman B, Sheridan P, Yusuf S, Gerstein HC, , Effect of Rosiglitazone and Ramipril on {beta}-cell function in people with impaired glucose tolerance or impaired fasting glucose: the DREAM trial., Diabetes Care, 2010, 33, 3, 608-613, doi: 10.2337/dc09-1579.

Additional files

Editorial Notes