Clinical trial NCT01182701: Cognitive Behavioral Intervention in Diabetes Self-Management
Official title: Cognitive Behavioral Intervention in Diabetes Self-Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Asian Pacific Islanders
Cognitive behavioral intervention
Lead sponsor: University of Hawaii
Sponsor class: OTHER
First posted: 2010-08-17
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


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

Primary outcomes:
measure: Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
timeFrame: Baseline
measure: Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
timeFrame: Post (6 weeks)
measure: Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
timeFrame: 6 months
measure: Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
timeFrame: 1 year
Secondary outcomes:
measure: Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
timeFrame: Baseline
measure: Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
timeFrame: Post (6 weeks)
measure: Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
timeFrame: 6 months
measure: Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
timeFrame: 1 year
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: University of Hawaii School of Nursing & Dental Hygiene
state: Hawaii
Study officials:
affiliation: Universtiy of Hawaii
name: Jillian Inouye, PhD, APRN
role: PRINCIPAL_INVESTIGATOR
References: