CClinicalTrials.gg
CompletedNCT01182480Updated Nov 5, 2014Results posted

Chronic Care Management/Patient Relationship Management Proof of Concept

An interventional study of Patient Relationship Management (PRM) Program in Diabetes Mellitus, sponsored by Denver Health and Hospital Authority. Completed at 1 site in United States. Open to participants aged 18 Years to 76 Years. Per ClinicalTrials.gov, last updated 2014-11-05.

Sponsored by Denver Health and Hospital Authority · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Not applicable
Ages
18 Years to 76 Years
Sex
All
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Study 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.

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Conditions studied

  • Diabetes Mellitus

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03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 47 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Denver Health and Hospital Authority is the lead sponsor of 84 studies on the registry; 4 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 76 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
47 participants (actual)

Interventions

  • BehavioralPatient 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.

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What researchers measure

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.

    Time frame: 3 months

Secondary outcomes

  1. Appointment Attendance

    As measured by no-show rates for appointments at all clinics during the study period, compared between intervention and control groups

    Time frame: 3 months

  2. Perceived Self-efficacy

    As measured by comparison of patient responses to validated assessment instrument administered at baseline and post-intervention

    Time frame: 3 months

  3. 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.

    Time frame: 3 months

07

Results

Posted Nov 5, 2014
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.

Participant flow

English and Spanish-speaking adult patients (18-76 years old) with diabetes in possession of cell phones who receive primary care at Sam Sandos Westside Family Health Center (Westside), a federally qualified community health center in the Denver Health integrated healthcare system in Denver, CO.

Participant flow — Overall Study
MilestoneText Intervention
Started47
Completed47
Not completed0

Outcome measures

PrimaryPatient 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.

Time frame:
3 months
Reported as:
Number · text message response rate (percent)
Patient Engagement
text message response rate (percent)Text Intervention
Patient Engagement68.14
SecondaryAppointment Attendance

As measured by no-show rates for appointments at all clinics during the study period, compared between intervention and control groups

Time frame:
3 months

Results for this outcome have not been posted.

SecondaryPerceived Self-efficacy

As measured by comparison of patient responses to validated assessment instrument administered at baseline and post-intervention

Time frame:
3 months

Results for this outcome have not been posted.

SecondaryGlycemic Control

Measured by patients' self-reported fasting blood glucose levels during the intervention period and compared to previous laboratory data in the medical record.

Time frame:
3 months

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Text Intervention—0/47 (0%)0/47 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Text Intervention
<=18 years0
Between 18 and 65 years44
>=65 years3
Age, Continuous
Age, Continuous(years)Text Intervention
Mean50.29 ± 11.24
Sex: Female, Male
Sex: Female, Male(Participants)Text Intervention
Female30
Male17
Region of Enrollment
Region of Enrollment(participants)Text Intervention
United States47
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Study locations

1 site
  • Denver Health and Hospital Authority
    Denver, Colorado 80204, United States
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References and documents

Publications

  • 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. PubMed 22435883 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01182480
Lead sponsor
Denver Health and Hospital Authority
Collaborators
Microsoft Corporation, EMC Consulting
Responsible party
Andrew W. Steele, MD, MPH, MSc (Director, Medical Informatics, Denver Health and Hospital Authority) — Principal investigator
First posted
Aug 16, 2010
Start date
May 2010
Primary completion
Mar 2011
Completion
May 2011
Results posted
Nov 5, 2014
Last update
Nov 5, 2014

Study contacts

Andrew W Steele, MD, MPH
principal investigator · Denver Health and Hospital Authority

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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