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Chronic Care Management/Patient Relationship Management Proof of Concept

Chronic Care Management/Patient Relationship Management Proof of Concept

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01182480
Enrollment
47
Registered
2010-08-16
Start date
2010-05-31
Completion date
2011-05-31
Last updated
2014-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

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.

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.

Sponsors

Microsoft Corporation
CollaboratorINDUSTRY
EMC Consulting
CollaboratorUNKNOWN
Denver Health and Hospital Authority
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 76 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
Patient Engagement3 monthsPatient 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.

Secondary

MeasureTime frameDescription
Appointment Attendance3 monthsAs measured by no-show rates for appointments at all clinics during the study period, compared between intervention and control groups
Perceived Self-efficacy3 monthsAs measured by comparison of patient responses to validated assessment instrument administered at baseline and post-intervention
Glycemic Control3 monthsMeasured by patients' self-reported fasting blood glucose levels during the intervention period and compared to previous laboratory data in the medical record.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

Exclusion criteria included a life expectancy less than six months, age \< 18 or \> 76, and either lacking possession of or inability to use a cell phone or glucometer.

Participants by arm

ArmCount
Text Intervention
Group of study participants who received the text message intervention over a 3-month period.
47
Total47

Baseline characteristics

CharacteristicText Intervention
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
3 Participants
Age, Categorical
Between 18 and 65 years
44 Participants
Age, Continuous50.29 years
STANDARD_DEVIATION 11.24
Region of Enrollment
United States
47 participants
Sex: Female, Male
Female
30 Participants
Sex: Female, Male
Male
17 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 47
serious
Total, serious adverse events
0 / 47

Outcome results

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.

Time frame: 3 months

Population: Group of study participants who received the text message intervention over a 3-month period.

ArmMeasureValue (NUMBER)
Text InterventionPatient Engagement68.14 text message response rate (percent)
Secondary

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

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.

Time frame: 3 months

Secondary

Perceived Self-efficacy

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

Time frame: 3 months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026