Blood pressure control in diabetes in primary care
| ISRCTN | ISRCTN12187583 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12187583 |
| Protocol serial number | RBG 00XX77 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Trent (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 09/12/2008
- 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
Dr Nigel Sturrock
Scientific
Scientific
Consultant Physician
Nottingham City Hospital NHS Trust
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To assess the effectiveness of a simple treatment algorithm in primary care in attaining the recommended blood pressure in patients with type 2 diabetes compared to usual practice. To assess the cost-effectiveness of the algorithm for improving blood pressure control in these patients. Assuming 40% of diabetics have a blood pressure of <140/80 an intracluster correlation coefficient (ICC) of 0.02 and an average cluster size of 45 type 2 diabetics per practice. Based on 80% power and 5% two-sided significance level 388 participants would be required in each arm of the study. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nutritional, metabolic and endocrine diseases: Diabetes |
| Intervention | Not provided at time of registration |
| Intervention type | Other |
| Primary outcome measure(s) |
Proportion of participants who have achieved good blood pressure control defined as reaching the recommended level of <140/80. |
| Key secondary outcome measure(s) |
Change in blood pressure from baseline, attendance at hypertension review appointments and patient satisfaction with the care received. Both measures will be assessed at 12 months post recruitment to the trial. |
| Completion date | 28/02/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | The study population will comprise all patients with type 2 diabetes on the lists of participating general practitioners who give informed consent to participate in the study. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2001 |
| Date of final enrolment | 28/02/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Consultant Physician
Nottingham
NG5 1PB
United Kingdom
NG5 1PB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2007 | Yes | No |
