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 |
| Secondary identifying numbers | N/A |
- 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
Professor Martin Eccles
Scientific
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 |
|---|---|
| martin.eccles@ncl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| Scientific title | |
| Study acronym | DREAM trial |
| Study objectives | To 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) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2001 |
| Completion date | 31/01/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 7500 |
| Key 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) |
| Key exclusion criteria | Does not comply with the above inclusion criteria. |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 31/01/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Centre for Health Services Research
Newcastle upon Tyne
NE2 4AA
United Kingdom
NE2 4AA
United Kingdom
Sponsor information
University of Newcastle upon Tyne (UK)
University/education
University/education
Centre for Health Services Research
21 Claremont Place
Newcastle upon Tyne
NE2 4AA
England
United Kingdom
| Website | http://www.ncl.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01kj2bm70 |
Funders
Funder type
University/education
Diabetes UK (UK) (ref: BDA:RD01/0002155NHS)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- DIABETES UK LIMITED, British Diabetic Association
- Location
- United Kingdom
Executive Northern & Yorkshire Regional R&D Programme NYRO ACJ (UK) (March 2000)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 21/03/2002 | Yes | No | |
| Results article | results | 01/03/2010 | Yes | No |
