- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00214474
Improving Diabetes Efforts Across Language and Literacy (IDEALL)
February 12, 2013 updated by: Agency for Healthcare Research and Quality (AHRQ)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
See above
Study Type
Interventional
Enrollment (Actual)
339
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94143-1364
- Ucsf Dept of Medicine Box 1364
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ATSM Intervention
ATSM Intervention: Automated Telephone Self-Management Support
|
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 Names:
|
Active Comparator: GMV Intervention
GMV Intervention: Group Medical Visits
|
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 Names:
|
No Intervention: Usual Care
Usual Care: Standard care for diabetic patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale
Time Frame: Baseline and 1 year
|
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.
|
Baseline and 1 year
|
Changes in Minutes of Moderate Physical Activity
Time Frame: Baseline and 1 year
|
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.
|
Baseline and 1 year
|
Changes in Minutes of Vigorous Exercise
Time Frame: Baseline and 1 year
|
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.
|
Baseline and 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Patient Assessment of Chronic Illness Care (PACIC)
Time Frame: Baseline and 1 year
|
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.
|
Baseline and 1 year
|
Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale
Time Frame: Baseline and 1 year
|
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.
|
Baseline and 1 year
|
Changes in Interpersonal Processes of Care (IPC) Scale
Time Frame: Baseline and 1 year
|
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.
|
Baseline and 1 year
|
Changes in the Physical Component Summary of the SF-12 Health Survey
Time Frame: Baseline and 1 year
|
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.
|
Baseline and 1 year
|
Changes in the Mental Component Summary of the SF-12 Health Survey
Time Frame: Baseline and 1 year
|
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.
|
Baseline and 1 year
|
Number of Days Spent in Bed Due to Health Problems
Time Frame: 1 year
|
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.
|
1 year
|
Proportion of Patients Reporting Diabetes Interference of Normal Daily Activities
Time Frame: 1 year
|
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.
|
1 year
|
Changes in Hemoglobin A1c Levels
Time Frame: Baseline and 1 year
|
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.
|
Baseline and 1 year
|
Changes in Systolic Blood Pressure (SBP)
Time Frame: Baseline and 1 year
|
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.
|
Baseline and 1 year
|
Changes in Diastolic Blood Pressure (DBP)
Time Frame: Baseline and 1 year
|
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.
|
Baseline and 1 year
|
Changes in Body Mass Index (BMI)
Time Frame: Baseline and 1 year
|
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.
|
Baseline and 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dean Schillinger, MD, University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2002
Primary Completion (Actual)
November 1, 2005
Study Completion (Actual)
November 1, 2005
Study Registration Dates
First Submitted
September 19, 2005
First Submitted That Met QC Criteria
September 19, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
February 13, 2013
Last Update Submitted That Met QC Criteria
February 12, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R21HS014864-01 (U.S. AHRQ Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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