Back to resultsExpanding Comparative Effectiveness Research (CER) Capability Through Complex Patient Relationship Management
Primary Purpose
Diabetes, Hyperlipidemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Message prompts
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes focused on measuring Text, SMS, diabetes, self-monitoring, self-management, adherence
Eligibility Criteria
Inclusion Criteria:
- age 18-75 years
- diabetes
- own a cell phone
- 2 primary care visits in last year
- English or Spanish speaking
Exclusion Criteria:
- End-stage disease with estimate of less than 6 months to live
Sites / Locations
- Denver Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
text message recipients
Arm Description
Patients will be recruited to receive text messages
Outcomes
Primary Outcome Measures
response rate to home monitoring prompts
resonse rate to blood pressure, blood sugar, and step count prompts
Secondary Outcome Measures
response rate to prompt for lab text by text message
response rate to prompt for lab text by text message
response to barrier questions for non-adherence
We will analyze the responses to text message prompts in patients late for picking up medications.
Full Information
NCT ID
NCT01391585
First Posted
July 8, 2011
Last Updated
February 10, 2014
Sponsor
Denver Health and Hospital Authority
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT01391585
Brief Title
Expanding Comparative Effectiveness Research (CER) Capability Through Complex Patient Relationship Management
Official Title
Expanding Comparative Effectiveness Research (CER) Capability Through Complex Patient Relationship Management
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Denver Health and Hospital Authority
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators are testing whether patients with diabetes can communicate with our health care system through text messaging. The investigators will look at how often they respond to prompts for blood pressures, blood sugars, and step counts. The investigators will also see if they come in for lab tests when prompted by text message. Also, for patients overdue for medication refills, the investigators will ask them why they have not yet called for the refill.
Detailed Description
Patients will be sent text messages through a software interface, the Patient Relationship Manager (PRM). A registered nurse will also use PRM to receive incoming responses. Tasks will be created for her to outreach to patients who have out of range text responses or poor response rates. This intervention if a feasibility study to see if patients can communicate with the investigator's health care system and potentially utilize PRM to better manage their diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hyperlipidemia
Keywords
Text, SMS, diabetes, self-monitoring, self-management, adherence
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
text message recipients
Arm Type
Experimental
Arm Description
Patients will be recruited to receive text messages
Intervention Type
Other
Intervention Name(s)
Text Message prompts
Intervention Description
In this single armed intervention, patients will receive text message prompts
Primary Outcome Measure Information:
Title
response rate to home monitoring prompts
Description
resonse rate to blood pressure, blood sugar, and step count prompts
Time Frame
4 months
Secondary Outcome Measure Information:
Title
response rate to prompt for lab text by text message
Description
response rate to prompt for lab text by text message
Time Frame
4 months
Title
response to barrier questions for non-adherence
Description
We will analyze the responses to text message prompts in patients late for picking up medications.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18-75 years
diabetes
own a cell phone
2 primary care visits in last year
English or Spanish speaking
Exclusion Criteria:
End-stage disease with estimate of less than 6 months to live
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
henry h fischer, MD
Organizational Affiliation
Denver Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Expanding Comparative Effectiveness Research (CER) Capability Through Complex Patient Relationship Management
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