Diabetes MellitusNCT01182480
Chronic Care Management/Patient Relationship Management Proof of Concept
A study testing Patient Relationship Management (PRM) Program in people with Diabetes Mellitus, run by Denver Health and Hospital Authority at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Patient Relationship Management (PRM) Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- life expectancy less than six months,
- do not have or cannot use a phone or glucometer
- do not want to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health and Hospital Authority
Denver, Colorado, 80204
About this study
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Patient Relationship Management (PRM) Program
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Relationship Management (PRM) ProgramBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
Appointment Attendance
As measured by no-show rates for appointments at all clinics during the study period, compared between intervention and control groups
Measured: 3 months
Perceived Self-efficacy
As measured by comparison of patient responses to validated assessment instrument administered at baseline and post-intervention
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionMar 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Microsoft Corporation, EMC Consulting
- Responsible party
- Principal investigator, Andrew W. Steele, MD, MPH, MSc, Denver Health and Hospital Authority
- Investigators
- Andrew W Steele, MD, MPH, Principal investigator, Denver Health and Hospital Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182480
- Sponsor's protocol ID
- COMIRB 10-0257
- Status last verified
- Oct 2014
- First submitted
- 11 Aug 2010
- Last updated
- 5 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Care Management/Patient Relationship Management Proof of Concept
- ClinicalTrials.gov ID
- NCT01182480
- Acronym / sponsor ID
- COMIRB 10-0257
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- Microsoft Corporation, EMC Consulting
- Study start
- May 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 16 Aug 2010 (estimated)
- Results
- Posted 5 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- life expectancy less than six months,
- do not have or cannot use a phone or glucometer
- do not want to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Relationship Management (PRM) ProgramPatients 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. | Behavioural | – |
Primary outcome
Patient Engagement
Time frame: 3 months
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 secondary outcomes
Appointment Attendance
Time frame: 3 months
Perceived Self-efficacy
Time frame: 3 months
Glycemic Control
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22435883Fischer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew W Steele, MD, MPH principal investigator
Denver Health and Hospital Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Relationship Management (PRM) Program in people with Diabetes Mellitus, run by Denver Health and Hospital Authority at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Engagement (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01182480, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2014.