Heart FailureNCT03149510
The Effects of Self-monitoring With a Mobile Application in Heart Failure
A study testing Mobile Application in people with Heart Failure, run by University of Michigan at 2 sites in United States.
Trial summary
In the United States, about 40 percent of heart failure (HF) patients are readmitted within 1-year following their first admission for HF and hospitalization accounts for approximately 70 percent of the costs of HF management. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Mobile Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Mar 2017to 30 Apr 2019
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45 years old or older
- Left ventricular ejection fraction </= 40% or an LVEF > 40% (with left atrial size >40mm or BNP > 200 pg/ml or NT-proBNP > 800 pg/ml)
- Admitted for acutely decompensated heart failure or recently discharged in the past 4 weeks.
- Smartphone (iOS or Android) with home wifi
Who cannot join
- Unstable coronary syndrome within 8 weeks (unstable angina, NSTEMI, STEMI)
- Primary valvular heart disease
- Known pericardial disease (Sarcoidosis, amyloidosis, rheumatoid arthritis, lupus)
- Uncorrected thyroid disease
- Advanced renal disease (dialysis or creatinine >4.0 mg/dL)
- End-stage HF (hospice candidate, home milrinone or dobutamine)
Show all 9Show fewer
- Active cancer
- Pulmonary fibrosis
- Discharge to a setting other than home
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109-2054
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
Official title: A Patient-centered Mobile Intervention to Promote Self-management and Improve Patient Outcomes in Chronic Heart Failure
In the United States, about 40 percent of heart failure (HF) patients are readmitted within 1-year following their first admission for HF and hospitalization accounts for approximately 70 percent of the costs of HF management. As a result, the management of HF patients is evolving from the traditional model of face-to-face follow-up visits toward a proactive real-time technological model of assisting patients with monitoring and self-management while in the community. The investigators plan to test the impact of a mobile application on clinical outcomes in HF.
Read the detailed description
HF patients with a reduced ejection fraction will be randomized to the mobile application versus placebo for 12 weeks. The mobile application will provide the participants with a reminder to perform self-monitoring, a health status indicator and heart failure education for self-management.
All participants will complete the Minnesota Living with Heart Failure Questionnaire and Self-Care Heart Failure Index. Hospital admissions and mortality will also be collected.
- Conditions
- Heart Failure
- Being tested
- Mobile Application
- Keywords
- mobile application, mHealth
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile ApplicationBehavioural
Participants will use the mobile application daily to assess heart failure symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Application | Experimental | Participants will be using a mobile application, activity monitor and scale. Receives: Behavioral: Mobile Application |
| Control Group | No intervention | Participants will receive standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
MLHFQ is a quality of life questionnaire for heart failure.
Measured: Change from Baseline MLHFQ at Week 12
Secondary outcomes (3)
Self-Care Heart Failure Index (SCHFI)
SCHFI is a survey of heart failure patient self-management.
Measured: Change from Baseline SCHFI at Week 12
Hospitalizations
Admission to the hospital while enrolled in the trial.
Measured: Over 12 weeks
Mortality
Death while enrolled in the trial.
Measured: Over 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start6 Mar 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd M Koelling, MD, University of Michigan
- Investigators
- Todd M Koelling, MD, Principal investigator, University of Michigan Heart Failure Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149510
- Sponsor's protocol ID
- HUM00123222
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2017
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dorsch MP, Farris KB, Bleske BE, Koelling TM. A web application for self-monitoring improves symptoms in chronic systolic heart failure. Telemed J E Health. 2015 Apr;21(4):267-70. doi: 10.1089/tmj.2014.0095. Epub 2015 Feb 5.
PubMed 25654615Bleske BE, Dillman NO, Cornelius D, Ward JK, Burson SC, Diez HL, Pickworth KK, Bennett MS, Nicklas JM, Dorsch MP. Heart failure assessment at the community pharmacy level: a feasibility pilot study. J Am Pharm Assoc (2003). 2014 Nov-Dec;54(6):634-41. doi: 10.1331/JAPhA.2014.14039.
PubMed 25379983Dorsch MP, Farris KB, Rowell BE, Hummel SL, Koelling TM. The Effects of the ManageHF4Life Mobile App on Patients With Chronic Heart Failure: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Dec 7;9(12):e26185. doi: 10.2196/26185.
PubMed 34878990
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient-centered Mobile Intervention to Promote Self-management and Improve Patient Outcomes in Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT03149510
- Acronym / sponsor ID
- HUM00123222
- Conditions
- Heart Failure
- Keywords
- mobile application, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 11 May 2017 (actual)
- 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.
In the United States, about 40 percent of heart failure (HF) patients are readmitted within 1-year following their first admission for HF and hospitalization accounts for approximately 70 percent of the costs of HF management. As a result, the management of HF patients is evolving from the traditional model of face-to-face follow-up visits toward a proactive real-time technological model of assisting patients with monitoring and self-management while in the community. The investigators plan to test the impact of a mobile application on clinical outcomes in HF.
Detailed description
HF patients with a reduced ejection fraction will be randomized to the mobile application versus placebo for 12 weeks. The mobile application will provide the participants with a reminder to perform self-monitoring, a health status indicator and heart failure education for self-management.
All participants will complete the Minnesota Living with Heart Failure Questionnaire and Self-Care Heart Failure Index. Hospital admissions and mortality will also be collected.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Application | Experimental | Behavioral: Mobile ApplicationParticipants will be using a mobile application, activity monitor and scale. |
| Control Group | No intervention | –Participants will receive standard of care. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 45 years old or older
- Left ventricular ejection fraction </= 40% or an LVEF > 40% (with left atrial size >40mm or BNP > 200 pg/ml or NT-proBNP > 800 pg/ml)
- Admitted for acutely decompensated heart failure or recently discharged in the past 4 weeks.
- Smartphone (iOS or Android) with home wifi
Key exclusion criteria (9 listed)
- Unstable coronary syndrome within 8 weeks (unstable angina, NSTEMI, STEMI)
- Primary valvular heart disease
- Known pericardial disease (Sarcoidosis, amyloidosis, rheumatoid arthritis, lupus)
- Uncorrected thyroid disease
- Advanced renal disease (dialysis or creatinine >4.0 mg/dL)
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 |
|---|---|---|
| Mobile ApplicationParticipants will use the mobile application daily to assess heart failure symptoms. | Behavioural | Mobile Application |
Primary outcome
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Time frame: Change from Baseline MLHFQ at Week 12
MLHFQ is a quality of life questionnaire for heart failure.
3 secondary outcomes
Self-Care Heart Failure Index (SCHFI)
Time frame: Change from Baseline SCHFI at Week 12
Hospitalizations
Time frame: Over 12 weeks
Mortality
Time frame: Over 12 weeks
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 2 Apr 2020.
- Background: PubMed 25654615Dorsch MP, Farris KB, Bleske BE, Koelling TM. A web application for self-monitoring improves symptoms in chronic systolic heart failure. Telemed J E Health. 2015 Apr;21(4):267-70. doi: 10.1089/tmj.2014.0095. Epub 2015 Feb 5.
- Background: PubMed 25379983Bleske BE, Dillman NO, Cornelius D, Ward JK, Burson SC, Diez HL, Pickworth KK, Bennett MS, Nicklas JM, Dorsch MP. Heart failure assessment at the community pharmacy level: a feasibility pilot study. J Am Pharm Assoc (2003). 2014 Nov-Dec;54(6):634-41. doi: 10.1331/JAPhA.2014.14039.
- Derived from this study: PubMed 34878990Dorsch MP, Farris KB, Rowell BE, Hummel SL, Koelling TM. The Effects of the ManageHF4Life Mobile App on Patients With Chronic Heart Failure: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Dec 7;9(12):e26185. doi: 10.2196/26185.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Todd M Koelling, MD principal investigator
University of Michigan Heart Failure Program
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application in people with Heart Failure, run by University of Michigan at 2 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 4 inclusion and 9 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 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Minnesota Living with Heart Failure Questionnaire (MLHFQ) (time frame: Change from Baseline MLHFQ at Week 12). 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 NCT03149510, which also lists 3 linked publications.
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 2 Apr 2020.