- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01182480
Chronic Care Management/Patient Relationship Management Proof of Concept
This proof of concept study proposes to evaluate the feasibility of a communications-technology-based chronic care and patient relationship management program to improve diabetes self management among adult diabetic patients in an urban safety net population by providing between-visit reminders and chronic disease support through cell phone text messaging.
The investigators hypothesize that diabetic patients enrolled in the program will be less likely to miss scheduled appointments and will have greater perceived self-efficacy and improved patient satisfaction concerning chronic disease management. No-show rates among patients enrolled in the program are expected to be lower than among patients receiving standard care.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80204
- Denver Health and Hospital Authority
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients with diabetes
- receive care at a primary care clinic in the DH system
- between 18 and 76 years of age
- primary language of English or Spanish
- ownership of a qualifying cell phone (SMS text capable)
- ownership of a glucometer.
Exclusion Criteria:
- life expectancy less than six months,
- do not have or cannot use a phone or glucometer
- do not want to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Engagement
Time Frame: 3 months
|
Patient engagement was assessed by patient text message response rates and average response times.
Response rates were calculated as a percentage from the number of patient-initiated text messages sent in response to a system-generated request for information (the numerator) divided by the total number of system-generated requests for information (the denominator).
Average response times were calculated from system-recorded time stamps for outbound requests sent and inbound patient-initiated responses received.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Appointment Attendance
Time Frame: 3 months
|
As measured by no-show rates for appointments at all clinics during the study period, compared between intervention and control groups
|
3 months
|
|
Perceived Self-efficacy
Time Frame: 3 months
|
As measured by comparison of patient responses to validated assessment instrument administered at baseline and post-intervention
|
3 months
|
|
Glycemic Control
Time Frame: 3 months
|
Measured by patients' self-reported fasting blood glucose levels during the intervention period and compared to previous laboratory data in the medical record.
|
3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Andrew W Steele, MD, MPH, Denver Health and Hospital Authority
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- COMIRB 10-0257
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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