Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes

NCT00299169 | Terminated Phase 4

• 2 other identifiers: R-06-135IRF-061-05
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who are intolerant of statins in routine practice, but who lack objective evidence of significant harm, will be randomized to receive statins by either n of 1 trials or standard practice. Our hypothesis is that n of 1 trials will improve statin adherence, thereby improving low density lipoprotein cholesterol (LDL-C) levels.

Conditions

Diabetes; Cardiovascular Disease; Hyperlipidemia

Keywords

N of 1 trial; diabetes mellitus; HMG CoA Reductase Inhibitors; cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• mean LDL levels

  end of study

Secondary Outcomes (1)

• the proportions of participants taking statins at the end of the trial

  end of study

Study Arms (2)

1

EXPERIMENTAL

N of 1 trials of statin therapy

Behavioral: N of 1 Trials

2

OTHER

usual care

Behavioral: N of 1 Trials

Interventions

N of 1 Trials BEHAVIORAL

N of 1 Trials of statin therapy

Also known as: usual care

1; 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Established diagnosis of type 1 or 2 diabetes
• Age 18-80 years
• Indication for a statin by the 2003 Canadian Diabetes Association (CDA) Clinical Practice Guidelines
• Willingness to re-try a statin despite previous apparent intolerance
• Provision of signed informed consent

You may not qualify if:

• Contraindication to a statin: previous rhabdomyolysis, active liver disease or unexplained persistent elevations of serum transaminases (CK, AST, ALT \>three times upper limit of normal), pregnancy or lactation
• Impaired renal function: severe renal insufficiency (creatinine clearance \<30 ml/min)
• Presence of a condition such as malignancy for which the one-year prognosis is poor
• Inability of the patient to comply with the rigorous conditions of the trial
• Any other condition deemed to render the study harmful to the participant

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

St. Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases; Hyperlipidemias

Interventions

Single-Case Studies as Topic

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Charlotte G McDonald, MD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2006
• First Posted: March 6, 2006
• Study Start: September 1, 2006
• Study Completion: November 1, 2007
• Last Updated: January 8, 2008

Record last verified: 2006-09

Locations

CA (1)