DiabetesNCT01391585
Expanding Comparative Effectiveness Research (CER) Capability Through Complex Patient Relationship Management
A study testing Text Message prompts in people with Diabetes and Hyperlipidemia, run by Denver Health and Hospital Authority at 1 site in United States.
Trial summary
The investigators are testing whether patients with diabetes can communicate with our health care system through text messaging. The investigators will look at how often they respond to prompts for blood pressures, blood sugars, and step counts. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes, Hyperlipidemia
- What is being tested?
- Text Message prompts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-75 years
- diabetes
- own a cell phone
- 2 primary care visits in last year
- English or Spanish speaking
Who cannot join
- End-stage disease with estimate of less than 6 months to live
Trial locations and contacts
1 site in 1 country.
About this study
The investigators are testing whether patients with diabetes can communicate with our health care system through text messaging. The investigators will look at how often they respond to prompts for blood pressures, blood sugars, and step counts. The investigators will also see if they come in for lab tests when prompted by text message. Also, for patients overdue for medication refills, the investigators will ask them why they have not yet called for the refill.
Read the detailed description
Patients will be sent text messages through a software interface, the Patient Relationship Manager (PRM). A registered nurse will also use PRM to receive incoming responses. Tasks will be created for her to outreach to patients who have out of range text responses or poor response rates. This intervention if a feasibility study to see if patients can communicate with the investigator's health care system and potentially utilize PRM to better manage their diabetes.
- Conditions
- Diabetes, Hyperlipidemia
- Being tested
- Text Message prompts
- Keywords
- Text, SMS, diabetes, self-monitoring, self-management, adherence
- Medical subject headings
- Diabetes Mellitus, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Message promptsOther
In this single armed intervention, patients will receive text message prompts
| Study group | Role | What they receive |
|---|---|---|
| text message recipients | Experimental | Patients will be recruited to receive text messages Receives: Other: Text Message prompts |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate to home monitoring prompts
resonse rate to blood pressure, blood sugar, and step count prompts
Measured: 4 months
Secondary outcomes (2)
response rate to prompt for lab text by text message
response rate to prompt for lab text by text message
Measured: 4 months
response to barrier questions for non-adherence
We will analyze the responses to text message prompts in patients late for picking up medications.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Henry Fischer, Denver Health and Hospital Authority
- Investigators
- henry h fischer, MD, Principal investigator, Denver Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391585
- Sponsor's protocol ID
- R24HS019453-01PRM
- Other IDs
- R24HS019453-01
- Status last verified
- Feb 2014
- First submitted
- 8 Jul 2011
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Comparative Effectiveness Research (CER) Capability Through Complex Patient Relationship Management
- ClinicalTrials.gov ID
- NCT01391585
- Acronym / sponsor ID
- R24HS019453-01PRM
- Conditions
- Diabetes, Hyperlipidemia
- Keywords
- Text, SMS, diabetes, self-monitoring, self-management, adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jun 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are testing whether patients with diabetes can communicate with our health care system through text messaging. The investigators will look at how often they respond to prompts for blood pressures, blood sugars, and step counts. The investigators will also see if they come in for lab tests when prompted by text message. Also, for patients overdue for medication refills, the investigators will ask them why they have not yet called for the refill.
Detailed description
Patients will be sent text messages through a software interface, the Patient Relationship Manager (PRM). A registered nurse will also use PRM to receive incoming responses. Tasks will be created for her to outreach to patients who have out of range text responses or poor response rates. This intervention if a feasibility study to see if patients can communicate with the investigator's health care system and potentially utilize PRM to better manage their diabetes.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| text message recipients | Experimental | Other: Text Message promptsPatients will be recruited to receive text messages |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18-75 years
- diabetes
- own a cell phone
- 2 primary care visits in last year
- English or Spanish speaking
Key exclusion criteria (1 listed)
- End-stage disease with estimate of less than 6 months to live
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 |
|---|---|---|
| Text Message promptsIn this single armed intervention, patients will receive text message prompts | Other | text message recipients |
Primary outcome
response rate to home monitoring prompts
Time frame: 4 months
resonse rate to blood pressure, blood sugar, and step count prompts
2 secondary outcomes
response rate to prompt for lab text by text message
Time frame: 4 months
response to barrier questions for non-adherence
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
Related trials for Diabetes
Active, not recruitingPhase 3
Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes
Diabetes Mellitus, Type 1
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Active, not recruiting
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
Nutrition, Type 2 Diabetes
RecruitingObservational study
Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy
Painful Diabetic Peripheral Neuropathy, Diabetes Complication
Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
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.
henry h fischer, MD principal investigator
Denver Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Message prompts in people with Diabetes and Hyperlipidemia, 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 5 inclusion and 1 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 11 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
response rate to home monitoring prompts (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2014.