Chronic Care Management/Patient Relationship Management Proof of Concept

October 29, 2014 updated by: Andrew W. Steele, MD, MPH, MSc, Denver Health and Hospital Authority

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

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

47

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

    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health and Hospital Authority

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 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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: 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

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

Investigators

  • Principal Investigator: Andrew W Steele, MD, MPH, Denver Health and Hospital Authority

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

May 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

August 11, 2010

First Submitted That Met QC Criteria

August 12, 2010

First Posted (Estimate)

August 16, 2010

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

October 29, 2014

Last Verified

October 1, 2014

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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