Cognitive Behavioral Intervention in Diabetes Self-Management
This study has been completed.
Sponsor:
University of Hawaii
Information provided by:
University of Hawaii
ClinicalTrials.gov Identifier:
NCT01182701
First received: August 6, 2010
Last updated: August 13, 2010
Last verified: August 2010
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes |
Behavioral: Cognitive behavioral training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Cognitive Behavioral Intervention in Diabetes Self-Management |
Resource links provided by NLM:
Further study details as provided by University of Hawaii:
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. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies. [ Time Frame: Post (6 weeks) ] [ Designated as safety issue: No ]
- Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 207 |
| Study Start Date: | August 2004 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Behavioral intervention |
Behavioral: Cognitive behavioral training
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 |
Eligibility| Ages Eligible for Study: | 18 Years to 76 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182701
Locations
| United States, Hawaii | |
| University of Hawaii School of Nursing & Dental Hygiene | |
| Honolulu, Hawaii, United States, 96822 | |
Sponsors and Collaborators
University of Hawaii
Investigators
| Principal Investigator: | Jillian Inouye, PhD, APRN | Universtiy of Hawaii |
More Information
No publications provided
| Responsible Party: | Jillian Inouye/Principal Investigator, University of Hawaii |
| ClinicalTrials.gov Identifier: | NCT01182701 History of Changes |
| Other Study ID Numbers: | 5R01NR007883 |
| Study First Received: | August 6, 2010 |
| Last Updated: | August 13, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Hawaii:
|
Type 2 Diabetes Asian Pacific Islanders Cognitive behavioral intervention |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on October 17, 2012
