Chronic Care Management/Patient Relationship Management Proof of Concept

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Microsoft Corporation
EMC Consulting
Information provided by:
Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT01182480
First received: August 11, 2010
Last updated: August 12, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Behavioral: Patient Relationship Management (PRM) Program

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Chronic Care Management/Patient Relationship Management Proof of Concept

Resource links provided by NLM:


Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome Measures:
  • Technology engagement [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Assessment of program feasibility by patient engagement and satisfaction with the technology-based intervention. Measured by analysis of response rates and average response times to medical requests and appointment reminders, and by content analysis of patient survey and focus group data.


Secondary Outcome Measures:
  • Appointment attendance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    As measured by no-show rates for appointments at all clinics during the study period, compared between intervention and control groups

  • Perceived self-efficacy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    As measured by comparison of patient responses to validated assessment instrument administered at baseline and post-intervention

  • Glycemic control [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measured by patients' self-reported fasting blood glucose levels during the intervention period and compared to previous laboratory data in the medical record.


Estimated Enrollment: 100
Study Start Date: May 2010
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Patient Relationship Management (PRM) Program

    Patients will be contacted through SMS text messaging under the following circumstances:

    • 7 days, 2 days, and 1 day before scheduled appointments. Messages will contain the date, time, and location where the appointment is scheduled. Patients will be prompted to respond with 'YES' if they are able to keep their appointment, and 'NO' if they need to reschedule. An acknowledgement of receipt will be sent in response to all patient-initiated messages.
    • 3 days per week to request that patients respond with fasting blood sugar measurements. An acknowledgement of receipt will be sent in response to all patient-initiated messages.
  Eligibility

Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01182480

Locations
United States, Colorado
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
Microsoft Corporation
EMC Consulting
Investigators
Principal Investigator: Andrew W Steele, MD, MPH Denver Health and Hospital Authority
  More Information

No publications provided

Responsible Party: Andrew W. Steele, MD, MPH, MSc, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT01182480     History of Changes
Other Study ID Numbers: COMIRB 10-0257
Study First Received: August 11, 2010
Last Updated: August 12, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014