- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01182701
Cognitive Behavioral Intervention in Diabetes Self-Management
August 13, 2010 updated by: University of Hawaii
The proposed study is a two arm randomized controlled trial with longitudinal follow-up that compares cognitive behavioral interventions (ENHANCE) to a control group with attention.
The experiment will consist of a repeated measure 2 X 3 design; Condition (Experiment vs. Control) by Time (Pre, Post, Follow Up).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
207
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96822
- University of Hawaii School of Nursing & Dental Hygiene
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 76 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Asian/Pacific Islander Men and Women with type 2 diabetes; asymptomatic for hyperglycemia
- Both men and women will be included in the study if they have a diagnosis of type 2 diabetes made by a physician and meet classification and diagnostic criteria established by the American Diabetes Association (American Diabetes Association, 1997)
- Between 18 and 76 years
- Participation in diabetes education program of University Specialty Clinics
Exclusion Criteria:
- Crippling arthritis
- Joint replacements that limit movement
- Neuromuscular disease with paralysis
- Severe eye disease or visually impaired
- Chronic renal failure and/or End Stage Renal Disease requiring hemodialysis or peritoneal dialysis
- Transplant recipient
- Foot Amputation
- Congestive Heart Failure
- New York Heart Class III/IV
- Previous Cerebral Vascular Accident (stroke) with residual paralysis
- Malignancy
- Chronic hepatitis C
- HIV disease
- Individuals who contemplate changing residence within the period of study and becoming inaccessible to the study should be discouraged from the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Behavioral intervention
|
The behavioral training group will be involved six group sessions focusing on cognitive behavioral training for stress and mood management, cognitive restructuring, empowerment, values clarification, problem solving and decision making via a manualized program
|
NO_INTERVENTION: Education support
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
Time Frame: Baseline
|
Baseline
|
Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
Time Frame: Post (6 weeks)
|
Post (6 weeks)
|
Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
Time Frame: 6 months
|
6 months
|
Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
Time Frame: Baseline
|
Baseline
|
Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
Time Frame: Post (6 weeks)
|
Post (6 weeks)
|
Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
Time Frame: 6 months
|
6 months
|
Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jillian Inouye, PhD, APRN, Universtiy of Hawaii
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2004
Primary Completion (ACTUAL)
February 1, 2010
Study Completion (ACTUAL)
February 1, 2010
Study Registration Dates
First Submitted
August 6, 2010
First Submitted That Met QC Criteria
August 13, 2010
First Posted (ESTIMATE)
August 17, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
August 17, 2010
Last Update Submitted That Met QC Criteria
August 13, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01NR007883 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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