NCT01182480

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

November 5, 2014

Completed
Last Updated

November 5, 2014

Status Verified

October 1, 2014

Enrollment Period

10 months

First QC Date

August 11, 2010

Results QC Date

July 11, 2012

Last Update Submit

October 29, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Appointment Attendance

    3 months

  • Perceived Self-efficacy

    3 months

  • Glycemic Control

    3 months

Interventions

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 Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • life expectancy less than six months,
  • do not have or cannot use a phone or glucometer
  • do not want to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

Related 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.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

Insufficient power (# appointments) to detect changes in attendance rates; technical issues with self-efficacy data resulting in inability to compare pre- and post- intervention; intervention period insufficient to assess impact on glycemic control.

Results Point of Contact

Title
Andrew W. Steele, MD, MPH, MSc
Organization
Denver Health and Hospital Authority

Study Officials

  • Andrew W Steele, MD, MPH

    Denver Health and Hospital Authority

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Medical Informatics

Study Record Dates

First Submitted

August 11, 2010

First Posted

August 16, 2010

Study Start

May 1, 2010

Primary Completion

March 1, 2011

Study Completion

May 1, 2011

Last Updated

November 5, 2014

Results First Posted

November 5, 2014

Record last verified: 2014-10

Locations