Improving Diabetes Efforts Across Language and Literacy (IDEALL)

This study has been completed.
Sponsor:
Collaborators:
The Commonwealth Fund
California HealthCare Foundation
Information provided by (Responsible Party):
Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier:
NCT00214474
First received: September 19, 2005
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

The IDEALL Project (Improving Diabetes Efforts Across Language and Literacy) is a 3-arm randomized controlled trial to explore contextual factors at the patient, clinician, and organizational level of two patient self-management support strategies. A communication technology-based intervention (automated telephone diabetes management) and an interpersonally-oriented intervention (group medical visits)will be compared to usual care for their ability to improve diabetes outcomes among vulnerable populations in 4 safety-net health centers in the University of California, San Francisco (UCSF) Collaborative Research Network.


Condition Intervention
Diabetes
Behavioral: ATSM Intervention
Behavioral: GMV Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Improving Diabetes Efforts Across Language and Literacy (IDEALL)

Resource links provided by NLM:


Further study details as provided by Agency for Healthcare Research and Quality (AHRQ):

Primary Outcome Measures:
  • Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    The Summary of Diabetes Self-Care Activities (SDSCA) Measure is a brief self-report questionnaire on diabetes self-management behaviors. The questionnaire assesses the frequency with which a patient followed a diabetes routine over the prior 7 days in five domains: diet, exercise, blood-glucose testing, foot care, and medication adherence. Based on SDSCA measure's author's recommendations, two separate scores can be derived: a Diabetes Self-management Behaviors score and a Self-reported Medication Adherence score. The Diabetes Self-management Behaviors score is used in this study. For this score, all items pertaining to diet, exercise, blood glucose testing, and foot care are averaged. The result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior. Change is calculated as 1-year score minus baseline score.

  • Changes in Minutes of Moderate Physical Activity [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    A measure of patients' physical activity is ascertained by asking patients the following question: "In the last 7 days, how many total minutes or hours did you do physical activity? Like walking, house cleaning or gardening." Number of minutes may range from 0 to 10080, with greater number of minutes indicating more physical activity.

  • Changes in Minutes of Vigorous Exercise [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    A measure of patients' vigorous exercise is ascertained by asking patients the following question: "In the last 7 days, how many total minutes or hours did you do the kind of exercise that makes you breathe hard, such as swimming, walking fast, or biking?" Number of minutes may range from 0 to 10080, with greater number of minutes indicating more vigorous exercise.


Secondary Outcome Measures:
  • Changes in Patient Assessment of Chronic Illness Care (PACIC) [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    The Patient Assessment of Chronic Illness Care (PACIC) is a 20-item patient report instrument that measures patients' perspectives on the structure of their care and collects patient reports on the extent to which they have received specific clinical services and actions during the past year that are aligned with the Chronic Care Model. The scale is intended to assess the receipt of care that is patient-centered, proactive, planned and includes collaborative goal setting, problem-solving and follow-up support. Each instrument item is scored on a 5-point scale ranging from 1 to 5 with higher score indicating better care. Scores are transformed to a 100-point scale and averaged across all items to create a total scale score. Change is calculated as 1-year score minus baseline score.

  • Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    The Patient Self-Management Scale was derived from a questionnaire used in the Diabetes Quality Improvement Project. The scale is designed to reflect patients' assessment of their ability to manage aspects of diabetes self-care in 5 separate areas (medication, diet, exercise, blood glucose monitoring, and foot care). Respondents are asked how difficult over the past year has it been to follow exactly as their doctor who takes care of their diabetes suggested. Possible scores for each scale item range from 0 to 100 with higher score indicating more self-efficacy. Total scale score is calculated as the average across all items. Change is calculated as 1-year score minus baseline score.

  • Changes in Interpersonal Processes of Care (IPC) Scale [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    The Interpersonal Processes of Care (IPC) captures patient reports of providers' communication over the prior year. The scale is intended to measure patients' assessment of providers' communication within 3 broad domains: communication (e.g., lack of clarity), decision making (e.g., patient-centered decision making), and interpersonal style (e.g., friendliness). Each instrument item is scored on a 5-point scale ranging from 1 to 5. Scores are transformed to a 100-point scale and averaged across all items to create a total scale score. Higher total scores indicate better communication. Change is calculated as 1-year score minus baseline score.

  • Changes in the Physical Component Summary of the SF-12 Health Survey [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome. Change is calculated as 1-year score minus baseline score.

  • Changes in the Mental Component Summary of the SF-12 Health Survey [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome. Change is calculated as 1-year score minus baseline score.

  • Number of Days Spent in Bed Due to Health Problems [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    A measure of patients' functional status is ascertained by asking patients the following question: "In the last 30 days, how many days did your health keep you in bed all or most of the day?" Number of days may range from 0 to 30, with lower number of days indicating better functional status.

  • Proportion of Patients Reporting Diabetes Interference of Normal Daily Activities [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    A measure of diabetes interference on patients is ascertained by asking patients the following question: "In the last 12 months, how often has your diabetes kept you from doing your normal daily activities, such as going to work, grocery shopping, and taking care of yourself and others?" Responses consist of 6 possible options: "Always", "Almost Always", "Often", "Sometimes", "Almost Never", and "Never". These responses are grouped into 2 categories, with one category consisting of "Always", "Almost Always", and "Often" responses while the other category consists of the remaining responses. The proportion of patients reporting diabetes interference is the number of patients in the first category divided by the number of patients in the 2 categories combined.

  • Changes in Hemoglobin A1c Levels [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    Hemoglobin A1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of hemoglobin A1c increases in a predictable way. This serves as a marker for average blood glucose levels over the previous months prior to the measurement. Higher amounts of hemoglobin A1c indicate poorer control of blood glucose levels and have been associated with cardiovascular disease. Change is calculated as 1-year level minus baseline level.

  • Changes in Systolic Blood Pressure (SBP) [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    Systolic blood pressure is the pressure exerted on arteries and vessels by the heart when it contracts and pushes blood through the arteries to the rest of the body. Change is calculated as 1-year pressure minus baseline pressure.

  • Changes in Diastolic Blood Pressure (DBP) [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    Diastolic blood pressure is the pressure exerted on the walls of the arteries and vessels in between heart beats, when the heart is relaxed and dilated, filling with blood. Change is calculated as 1-year pressure minus baseline pressure.

  • Changes in Body Mass Index (BMI) [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    Body Mass Index (BMI) is a number calculated from a person's weight and height. BMI is defined as the individual's body mass divided by the square of their height. The formulae used produce a unit of measure of kg/m2. BMI provides an indicator of body fatness.


Enrollment: 339
Study Start Date: November 2002
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ATSM Intervention
ATSM Intervention: Automated Telephone Self-Management Support
Behavioral: ATSM Intervention
Participants randomized to ATSM Intervention received weekly, automated (pre-recorded) telephone calls over 39 weeks (9 months). Patient responses triggered either immediate, automated health education messages and/or subsequent nurse phone follow-up.
Other Name: ATSM: Automated Telephone Self-Management Support
Active Comparator: GMV Intervention
GMV Intervention: Group Medical Visits
Behavioral: GMV Intervention
GMV Intervention involved 90-minute monthly sessions over 9 months, involving 6-10 participants, co-facilitated by a primary care physician and health educator.
Other Name: GMV: Group Medical Visits
No Intervention: Usual Care
Usual Care: Standard care for diabetic patients

Detailed Description:

See above

  Eligibility

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

Inclusion Criteria:

  • have type 2 diabetes
  • have a HbA1c equal to or > 8.0%
  • must speak English, Spanish, or Cantonese.

Exclusion Criteria:

  • Dementia
  • Psychosis/Schizophrenia
  • End Stage Renal Disease
  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: NCT00214474

Locations
United States, California
Ucsf Dept of Medicine Box 1364
San Francisco, California, United States, 94143-1364
Sponsors and Collaborators
The Commonwealth Fund
California HealthCare Foundation
Investigators
Principal Investigator: Dean Schillinger, MD University of California, San Francisco
  More Information

No publications provided by Agency for Healthcare Research and Quality (AHRQ)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier: NCT00214474     History of Changes
Other Study ID Numbers: 1 R21 HS014864-01
Study First Received: September 19, 2005
Last Updated: February 12, 2013
Health Authority: United States: Federal Government

Keywords provided by Agency for Healthcare Research and Quality (AHRQ):
Disease Management
Health Literacy
Telephone Care
Group Medical Visits
Type 2 Diabetes
Access to Care
Technology
Language Barriers

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 26, 2014