Diabetes MellitusTARGET-HFDMNCT02918175
Mobile Health Behavioral Intervention in Patients With Heart Failure and Diabetes Mellitus
A study testing mHealth in people with Diabetes Mellitus and Heart Failure, run by Duke University at 6 sites in United States.
Trial summary
The overall objective of this study is to test a personalized mHealth intervention designed to increase physical activity and improve medication adherence in subjects with heart failure and diabetes mellitus. The study will leverage consumer technology as both an intervention and as a tool for data collection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Heart Failure
- What is being tested?
- mHealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 6 sitesUnited States
- Study dates
- 2 Aug 2017to 9 Sep 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Chronic heart failure, New York Heart Association (NYHA) class II-IV, with ongoing treatment with medications for heart failure for at least 1 month prior to enrollment
- Prior diabetes mellitus diagnosis, with ongoing treatment with anti-diabetes medications for at least 1 month prior to enrollment
- Adequate clinical stability in the judgment of the investigator to allow participation in study assessments and the intervention
- Independent with basic activities of daily living (ADLs), including the ability to ambulate independently
- No plan for revascularization (cardiac or peripheral), outpatient continuous intravenous inotrope administration, cardiac transplant or ventricular assist device implantation, or other cardiac surgery within 6 months of randomization
- Access to a compatible smart phone (iOS or Android)
- Signed informed consent
Who cannot join
- Acute myocardial infarction within prior 4 weeks
- Already actively participating in formal, facility-based cardiac rehabilitation
- Severe stenotic valvular disease (e.g., severe aortic stenosis)
- Implanted left ventricular assist device (LVAD)
- Recipient of a heart transplant
- Terminal illness other than heart failure with life expectancy < 6 months
- Impairment from stroke, injury or other medical disorder that precludes participation in the intervention
- Inability or unwillingness to comply with the study requirements
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27705
Inova Health System
Fairfax, Virginia, 22042-3300
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Technology to Improve Drug Adherence and Reinforce Guideline Based Exercise Targets in Patients With Heart Failure and Diabetes Mellitus (TARGET-HFDM)
The overall objective of this study is to test a personalized mHealth intervention designed to increase physical activity and improve medication adherence in subjects with heart failure and diabetes mellitus. The study will leverage consumer technology as both an intervention and as a tool for data collection.
Read the detailed description
This is a multi-center randomized controlled study in eligible subjects with heart failure and diabetes mellitus. Step counts, self-reported quality of life, medication adherence, blood samples and relevant clinical measures will be collected from all study subjects. The mobile health (mHealth) intervention will combine personalized text messages to encourage physical activity and a medication adherence teaching tool. A total of approximately 200 eligible subjects will be randomized in in a 1:1 ratio to either mHealth intervention + usual care/data collection or the control group (usual care/data collection only). The study duration is 6 months for all subjects; those in the intervention group will receive the mHealth intervention during the initial 3 months followed by 3 months of data collection only. The underlying hypotheses is that the proposed mHealth intervention can favorably impact specific health behaviors (physical activity and medication adherence) and physiologic measures of disease status for both heart failure and diabetes. Additional hypotheses to be tested will assess the persistence of behavioral changes (daily physical activity and medication adherence) and physiologic measures (NT-proBNP, HbA1c) beyond the 3-month time point of the active mHealth intervention (i.e. through 6 months).
- Conditions
- Diabetes Mellitus, Heart Failure
- Being tested
- mHealth
- Keywords
- mHealth
- Medical subject headings
- Diabetes Mellitus, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealthBehavioural
Also called Feedback on step counts, Duke PillBox medication adherence teaching tool
Personalized step count feedback and medication teaching tool.
| Study group | Role | What they receive |
|---|---|---|
| mHealth Intervention | Other | Subjects in this study arm will have data on activity levels, quality of life, medication adherence, and blood samples collected. In addition, they will receive personalized feedback on activity goals based on prior week step counts and participate in coaching sessions using the Pillbox medication tool. Receives: Behavioral: mHealth |
| No intervention | No intervention | Subjects in this study arm will have data on activity levels, quality of life, medication adherence, and blood samples collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean weekly step count
Increased activity
Measured: from baseline to 3 months
Secondary outcomes (6)
Change in medication adherence score
Improved medication adherence
Measured: from baseline to 3 and 6 months
Change in fill and refill performance rate
Change in fill and refill performance rate
Measured: from baseline to 3 and 6 months
Change in mean weekly step count
Increased activity
Measured: from 3 to 6 months
Change in NT-proBNP levels
biomarkers
Measured: from baseline to 3 to 6 months
Change in HbA1C levels
biomarkers
Measured: from baseline to 3 to 6 months
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
QOL
Measured: from baseline to 3 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study start2 Aug 2017
- Primary completion9 Sep 2020
- Study completion9 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Clinical Research Institute, American Heart Association
- Responsible party
- Sponsor
- Investigators
- Gary M Felker, MD, Principal investigator, Duke University Medical Center/Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918175
- Sponsor's protocol ID
- Pro00075572
- Other IDs
- 16SFRN30740010
- Acronym
- TARGET-HFDM
- Status last verified
- Nov 2019
- First submitted
- 27 Sep 2016
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology to Improve Drug Adherence and Reinforce Guideline Based Exercise Targets in Patients With Heart Failure and Diabetes Mellitus (TARGET-HFDM)
- ClinicalTrials.gov ID
- NCT02918175
- Acronym / sponsor ID
- TARGET-HFDM / Pro00075572
- Conditions
- Diabetes Mellitus, Heart Failure
- Keywords
- mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Duke Clinical Research Institute, American Heart Association
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 28 Sep 2016 (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 overall objective of this study is to test a personalized mHealth intervention designed to increase physical activity and improve medication adherence in subjects with heart failure and diabetes mellitus. The study will leverage consumer technology as both an intervention and as a tool for data collection.
Detailed description
This is a multi-center randomized controlled study in eligible subjects with heart failure and diabetes mellitus. Step counts, self-reported quality of life, medication adherence, blood samples and relevant clinical measures will be collected from all study subjects. The mobile health (mHealth) intervention will combine personalized text messages to encourage physical activity and a medication adherence teaching tool. A total of approximately 200 eligible subjects will be randomized in in a 1:1 ratio to either mHealth intervention + usual care/data collection or the control group (usual care/data collection only). The study duration is 6 months for all subjects; those in the intervention group will receive the mHealth intervention during the initial 3 months followed by 3 months of data collection only. The underlying hypotheses is that the proposed mHealth intervention can favorably impact specific health behaviors (physical activity and medication adherence) and physiologic measures of disease status for both heart failure and diabetes. Additional hypotheses to be tested will assess the persistence of behavioral changes (daily physical activity and medication adherence) and physiologic measures (NT-proBNP, HbA1c) beyond the 3-month time point of the active mHealth intervention (i.e. through 6 months).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth Intervention | Other | Behavioral: mHealthSubjects in this study arm will have data on activity levels, quality of life, medication adherence, and blood samples collected. In addition, they will receive personalized feedback on activity goals based on prior week step counts and participate in coaching sessions using the Pillbox medication tool. |
| No intervention | No intervention | –Subjects in this study arm will have data on activity levels, quality of life, medication adherence, and blood samples collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 18 years of age
- Chronic heart failure, New York Heart Association (NYHA) class II-IV, with ongoing treatment with medications for heart failure for at least 1 month prior to enrollment
- Prior diabetes mellitus diagnosis, with ongoing treatment with anti-diabetes medications for at least 1 month prior to enrollment
- Adequate clinical stability in the judgment of the investigator to allow participation in study assessments and the intervention
- Independent with basic activities of daily living (ADLs), including the ability to ambulate independently
Key exclusion criteria (8 listed)
- Acute myocardial infarction within prior 4 weeks
- Already actively participating in formal, facility-based cardiac rehabilitation
- Severe stenotic valvular disease (e.g., severe aortic stenosis)
- Implanted left ventricular assist device (LVAD)
- Recipient of a heart transplant
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 |
|---|---|---|
| mHealthAlso: Feedback on step counts, Duke PillBox medication adherence teaching toolPersonalized step count feedback and medication teaching tool. | Behavioural | mHealth Intervention |
Primary outcome
Change in mean weekly step count
Time frame: from baseline to 3 months
Increased activity
6 secondary outcomes
Change in medication adherence score
Time frame: from baseline to 3 and 6 months
Change in fill and refill performance rate
Time frame: from baseline to 3 and 6 months
Change in mean weekly step count
Time frame: from 3 to 6 months
Change in NT-proBNP levels
Time frame: from baseline to 3 to 6 months
Change in HbA1C levels
Time frame: from baseline to 3 to 6 months
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Time frame: from baseline to 3 to 6 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 3 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Gary M Felker, MD principal investigator
Duke University Medical Center/Duke Clinical Research Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth in people with Diabetes Mellitus and Heart Failure, run by Duke University at 6 sites 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 8 inclusion and 8 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 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Change in mean weekly step count (time frame: from baseline to 3 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 3 Nov 2020.