The Impact of Laboratory-based Prompts on the Management of Patients with Chronic Kidney Disease
| ISRCTN | ISRCTN26610787 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26610787 |
| Secondary identifying numbers | N/A |
- Submission date
- 10/02/2006
- Registration date
- 10/07/2006
- Last edited
- 14/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Bruce Culleton
Scientific
Scientific
1403-29th St NW
Calgary
Alberta
T2N 2T9
Canada
| Phone | +1403 944 8166 |
|---|---|
| bruce.culleton@calgaryhealthregion.ca |
Study information
| Study design | Cluster randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| Scientific title | |
| Study objectives | A laboratory prompt, which identifies a patient with chronic kidney disease (CKD) as being at high risk for cardiovascular disease and progression to kidney failure, improves the management of cardiovascular disease risk factors and kidney disease by physicians. |
| Ethics approval(s) | Approved by Bioethics Committess at the University of Calgary and the University of Alberta, 2005, reference number: 18050 |
| Health condition(s) or problem(s) studied | Chronic kidney disease |
| Intervention | The following prompt will be added to laboratory reports for patients who meet the inclusion criteria and are seen by a physician practice randomized to receive the prompt: This patient has reduced kidney function and is at risk for cardiovascular events and progression to kidney failure. The National Kidney Foundation recommends: 1. Measure random urine albumin to creatinine (Alb:Cr) ratio 2. Institute an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) in patients with diabetes, or those with an Alb:Cr >35 mg/mmol 3. Referral to a nephrologist if GFR <30 ml/min/1.73 m^2 4. Assess and treat modifiable risk factors for cardiovascular (CV) and renal disease: a. Target blood pressure (BP) less than 130/80 mmHg b. Target low-density lipoprotein cholesterol(LDL-C) <2.5 mmol/l c. If diabetic, target hemoglobin A1C (HbA1C) <7.0% The above recommendations are general in nature and may not apply to all patients. Further information is available at http://www.akdn.info The control group will receive usual care. |
| Intervention type | Other |
| Primary outcome measure | Use of ACEi or ARB in patients >65 years of age with CKD who have a clear indication for ACEi or ARB use as defined by the presence of diabetes or significant albuminuria. |
| Secondary outcome measures | 1. Use of an ACEi or ARB in patients >65 years of age with CKD 2. Subsequent measurement of lipids, hemoglobin A1C (in patients with diabetes, if not done in previous six months), urine protein or urine albumin, and subsequent frequency of measurement of serum creatinine 3. Referral to a specialist 4. Addition of cholesterol-lowering drugs in patients >65 years of age 5. Addition of new blood pressure medication(s) in patients >65 years of age 6. Health care costs |
| Overall study start date | 01/04/2006 |
| Completion date | 31/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 46 Family Practices per group (92 total) |
| Key inclusion criteria | All patients >18 years of age who are registered with one of the participating general practices and have a GFR measured at <60 ml/min during the one-year study period will be included. All participating general practices will be geographically separated (not located in the same office building), and staffed by >1 full time practitioners who do not see outpatients in another general practice unit (to reduce the risk of contamination). |
| Key exclusion criteria | Those patients not meeting the inclusion criteria. |
| Date of first enrolment | 01/04/2006 |
| Date of final enrolment | 31/03/2008 |
Locations
Countries of recruitment
- Canada
Study participating centre
1403-29th St NW
Alberta
T2N 2T9
Canada
T2N 2T9
Canada
Sponsor information
Alberta Heritage Foundation for Medical Research (Canada)
Research organisation
Research organisation
Suite 1500
10104-103 Avenue
Edmonton
T5J 4A7
Canada
| Phone | +1 780 423 5727 |
|---|---|
| ahfmrinfo@ahfmr.ab.ca | |
| Website | http://www.ahfmr.ab.ca |
"ROR" |
https://ror.org/006b2g567 |
Funders
Funder type
Research organisation
Alberta Heritage Foundation for Medical Research (Canada)
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- AHFMR
- Location
- Canada
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 |
