Back to resultsCognitive Behavioral Intervention in Diabetes Self-Management
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral training
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Asian Pacific Islanders, Cognitive behavioral intervention
Eligibility Criteria
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
Sites / Locations
- University of Hawaii School of Nursing & Dental Hygiene
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Behavioral intervention
Education support
Arm Description
Outcomes
Primary Outcome Measures
Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
Secondary Outcome Measures
Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01182701
Brief Title
Cognitive Behavioral Intervention in Diabetes Self-Management
Official Title
Cognitive Behavioral Intervention in Diabetes Self-Management
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Hawaii
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 Diabetes, Asian Pacific Islanders, Cognitive behavioral intervention
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
207 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral intervention
Arm Type
Active Comparator
Arm Title
Education support
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral training
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Title
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)
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
Time Frame
Baseline
Title
Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
Time Frame
Post (6 weeks)
Title
Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
Time Frame
6 months
Title
Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jillian Inouye, PhD, APRN
Organizational Affiliation
Universtiy of Hawaii
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hawaii School of Nursing & Dental Hygiene
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96822
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cognitive Behavioral Intervention in Diabetes Self-Management
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