Chronic Care Management/Patient Relationship Management Proof of Concept

Diabetes Mellitus Clinical Trial

Official title:

Chronic Care Management/Patient Relationship Management Proof of Concept

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01182480
• Other study ID #: COMIRB 10-0257
• Status: Completed
• Phase: N/A
• First received: August 11, 2010
• Last updated: October 29, 2014
• Start date: May 2010
• Est. completion date: May 2011

Study information

• Verified date: October 2014
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 76 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	Denver Health and Hospital Authority	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority	EMC Consulting, Microsoft Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fischer HH, Moore SL, Ginosar D, Davidson AJ, Rice-Peterson CM, Durfee MJ, MacKenzie TD, Estacio RO, Steele AW. Care by cell phone: text messaging for chronic disease management. Am J Manag Care. 2012 Feb 1;18(2):e42-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Engagement	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	No
Secondary	Appointment Attendance	As measured by no-show rates for appointments at all clinics during the study period, compared between intervention and control groups	3 months	No
Secondary	Perceived Self-efficacy	As measured by comparison of patient responses to validated assessment instrument administered at baseline and post-intervention	3 months	No
Secondary	Glycemic Control	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	No