Enhancing Adherence in Type 2 Diabetes: The ENHANCE Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00222846
First received: September 12, 2005
Last updated: May 14, 2010
Last verified: May 2010
  Purpose

This randomized study will test a behavioral intervention, based on social cognitive theory (SCT), to improve regimen adherence in three different groups of people with type 2 diabetes; (1) those with well controlled blood glucoses and no concurrent chronic renal insufficiency, (2) those with less well-controlled glucoses and no chronic renal insufficiency, and (3) those with chronic renal insufficiency regardless of glucose control. The primary aims of this study are to: (1)determine whether the intervention improves behavioral adherence to the diabetes self-management regimen including dietary adherence, physical activity, and capillary glucose self-monitoring; (2)determine whether the intervention improves clinical outcomes; (3) explore the extent to which self-efficacy is a mediator of adherence,(4) explore the extent to which the effectiveness of the intervention varies with respect to glycemic control and nephrovascular complications at baseline, and (5)explore the impact of a variety of covariates on the effectiveness of the intervention.

Hypothesis #1 is that intervention group participants will perform better than attention control group participants on various measures of adherence to the diabetes management regimen. Primary adherence variables will be dietary intake, and physical activity. Hypothesis #2 is that intervention group participants will have lower HbA1c levels than attention control group participants.


Condition Intervention
Diabetes Mellitus, Type 2
Diabetic Nephropathy
Behavioral: Attention control
Behavioral: Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Enhancing Adherence in Type 2 Diabetics

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Physical activity CHAMPS [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • Glycemic control - HbA1c [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • Dietary adherence [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adherence to capillary glucose checks - glucometer uploads [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • Weight loss [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 288
Study Start Date: May 2004
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Attention control
Behavioral: Attention control
Participants attend 3 educational seminars, receive a lay diabetes journal, pedometer, and glucose monitoring supplies.
Experimental: B
Intervention
Behavioral: Intervention
Behavioral intervention of diabetes self-management paired with PDA-based monitoring of dietary intake and physical activity. Participants also receive a pedometer and glucose self-monitoring supplies.

Detailed Description:

This randomized study, the ENHANCE Study (Enhancing Adherence to Diabetes Self-Management) will test a behavioral intervention, based on social cognitive theory (SCT), to improve regimen adherence in three different groups of people with type 2 diabetes; (1) HbA1c < 8% and no concurrent chronic renal insufficiency, (2) HbA1c>8% and no chronic renal insufficiency, and (3) those with evidence of chronic renal insufficiency regardless of glucose control.

The primary aims of this study are to:

  1. . Determine whether the intervention improves behavioral adherence to the diabetes self-management regimen including: 1.a. dietary adherence, as measured by self-report using dietary recalls and the Nutrient Data System, 1.b. physical activity as measured by the CHAMPS Physical Activity Questionnaire as well as pedometer readings, and 1.c. adherence to capillary glucose self-monitoring as assessed by the FreeStyle monitor.
  2. . Determine whether the intervention improves clinical outcome measures including: 2.a. glycosylated hemoglobin levels (HbA1c), 2.b. weight loss, 2.c. anthropometrics.
  3. . Explore the extent to which self-efficacy is a mediator of adherence.
  4. . Explore the extent to which the effectiveness of the intervention varies with respect to glycemic control and nephrovascular complications at baseline.
  5. . Explore the impact of a variety of covariates (medications, depression, social support, severity of disease, and general health and sociodemographic characteristics, clinic from which they were recruited, health literacy, and trust in research) on the effectiveness of the intervention.

Hypothesis #1 is that intervention group participants will perform better than attention control group participants on various measures of adherence to the diabetes management regimen. Primary behavioral adherence variables will be dietary intake, and physical activity. Hypothesis #2 is that intervention group participants will have lower HbA1c levels than attention control group participants.

The 6-month intervention includes group classes, held weekly during months 1&2, biweekly during months 3&4, and monthly during month 5&6. Classes focus on building a sense of mastery over the diabetes regimen and features the use of PDA-base dietary self-monitoring. Intervention group participants are compared to an attention care group, that receives monthly contacts. Measurements are made at baseline, 3, and 6 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Study subjects will include those with: type 2 diabetes mellitus defined according to the 1997 ADA criteria and age of 18 years or greater. We will sample from three different patient populations: (1) 96 individuals who have HbA1c < 8%, and no evidence of chronic renal insufficiency (a serum creatinine <1.3mg/dl for women and <1.5mg/dl for men). (2) 96 individuals with HbA1c > 8%, and no evidence of chronic renal insufficiency, and (3) 96 individuals with evidence of chronic renal insufficiency (a serum creatinine >1.3mg/dl for women and >1.5mg/dl for men, but who have not yet progressed to dialysis), regardless of HbA1c level.

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Exclusion Criteria: Exclusion criteria were selected to enhance safety and ability to complete the study protocol. They include: (1) history of hypoglycemic coma/seizure within the last 12 months, (2) hypoglycemia requiring 3rd party assistance within the last 3 months, (3) history consistent with type 1 diabetes, (4) unwillingness to do capillary blood testing using the FreeStyle monitor, (5) unwillingness or inability to participate in scheduled group classes or individual counseling sessions, (7) subjects currently on renal dialysis, (8) any factors likely to preclude adherence to the study protocol including dementia, alcohol or substance abuse, plan to move within the next 8 months, lack of support from the subject's primary health care provider (i.e. PCP is aware of significant risks such as extreme variation in blood glucoses and/or comorbidities that would make participation in the study unsafe), failure to obtain informed consent from the participant, current participation in another clinical trial, and (9) subjects who are not available by telephone during the hours of 8am to 6pm.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00222846

Locations
United States, Pennsylvania
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Mary A Sevick, ScD, RN University of PIttsburgh & Veterans Health Administration
  More Information

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mary Ann Sevick, ScD, RN, School of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00222846     History of Changes
Other Study ID Numbers: NIH-R01-NR008792
Study First Received: September 12, 2005
Last Updated: May 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Clinical trial
Behavioral research
Patient compliance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on April 17, 2014