Expanding Comparative Effectiveness Research (CER) Capability Through Complex Patient Relationship Management

February 10, 2014 updated by: Henry Fischer, Denver Health and Hospital Authority
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

135

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

  • United States
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: text message recipients
Patients will be recruited to receive text messages
Other: Text Message prompts
In this single armed intervention, patients will receive text message prompts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response rate to home monitoring prompts
Time Frame: 4 months
resonse rate to blood pressure, blood sugar, and step count prompts
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response rate to prompt for lab text by text message
Time Frame: 4 months
response rate to prompt for lab text by text message
4 months
response to barrier questions for non-adherence
Time Frame: 4 months
We will analyze the responses to text message prompts in patients late for picking up medications.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Denver Health and Hospital Authority

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: henry h fischer, MD, Denver Health

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

June 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

July 8, 2011

First Submitted That Met QC Criteria

July 11, 2011

First Posted (Estimate)

July 12, 2011

Study Record Updates

Last Update Posted (Estimate)

February 11, 2014

Last Update Submitted That Met QC Criteria

February 10, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R24HS019453-01PRM
  • R24HS019453-01 (U.S. NIH 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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