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Cognitive Behavioral Intervention in Diabetes Self-Management

This study has been completed.
Sponsor:
Information provided by:
University of Hawaii
ClinicalTrials.gov Identifier:
NCT01182701
First received: August 6, 2010
Last updated: August 13, 2010
Last verified: August 2010
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 24, 2014