Heart FailureI-COACHNCT04304833
Innovative Care of Older Adults With Chronic Heart Failure: A Comparative Effectiveness Clinical Trial (I-COACH)
A study testing Provider-Based Care Model Arm and mHealth Model Arm in people with Heart Failure, run by University of Arkansas at 1 site in United States.
Trial summary
An estimated 6.5 million adults in the U.S. have Heart Failure (HF) and the prevalence is increasing. HF is characterized by poor quality of life but this is amenable to self-management. However, the amount of support available from providers to help manage complications is far beyond what is feasible. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Provider-Based Care Model Arm and mHealth Model Arm
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2020to 25 Oct 2021
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged > 55 years with HF (documented in medical record).
- Has capacity to understand informed consent.
- Able to stand (briefly) without assistance.
- Has a designated caregiver.
- Agrees to be followed (treated) by UAMS physician/provider for 6 months after discharge.
Who cannot join
- Speaks a language other than English or Spanish.
- Active psychosis or other severe cognitive disorder that interferes with capacity to understand and comply with study procedures.
- A history of drug or alcohol abuse in the past 90 days (documented in medical record).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Innovative Care of Older Adults With Chronic Heart Failure (I-COACH): A Comparative Effectiveness Clinical Trial
An estimated 6.5 million adults in the U.S. have Heart Failure (HF) and the prevalence is increasing. HF is characterized by poor quality of life but this is amenable to self-management. However, the amount of support available from providers to help manage complications is far beyond what is feasible. The complex needs of these patients require a new vision for delivery of health care services, such as an mHealth management model. mHealth technologies such as blue-tooth enabled BP, heart rate, weight, and pulse oximetry remote monitoring permit sharing of immediate biometric data and video messages with providers and instantaneous feedback to patients before symptom crises, that is, when and where patients need it.
Read the detailed description
An estimated 6.5 million adults in the U.S. have Heart Failure (HF) and the prevalence is increasing. HF is characterized by poor quality of life but this is amenable to self-management. However, the amount of support available from providers to help manage complications is far beyond what is feasible. The complex needs of these patients require a new vision for delivery of health care services, such as an mHealth management model. mHealth technologies such as blue-tooth enabled BP, heart rate, weight, and pulse oximetry remote monitoring permit sharing of immediate biometric data and video messages with providers and instantaneous feedback to patients before symptom crises, that is, when and where patients need it.
This is a single-blinded comparative effectiveness randomized controlled trial conducted in a real-world setting. A sample of 400 dyads, that is older patients with HF (>55 years) and their caregivers, will be recruited from a large medical center and randomly assigned to one of two arms: 200 dyads to a provider-directed model or 200 dyads to the mHealth management model. The provider-directed management model is the current care standard for patients with HF; care delivery consists of office and emergency visits, with telephone or in person communications. The standard of care will be augmented by providing home equipment kits with weight scale, blood pressure, pulse oximetry devices and a Log to record data. The mHealth care management model consists of real time bio-monitoring kits and telemedicine visits using a secure wireless gateway with a cloud-based clinician portal connected to a Bluetooth-paired Android Tablet. Daily readings are transmitted to a 24-hour RN call center and triaged per protocols. Outcomes informed a prior by community stakeholders to be most important at the patient, caregiver, and health systems-levels will be collected and compared at baseline, 3- and 6- months: 1) For the patient: self-care of HF; confidence and self-efficacy to manage care, symptoms, medications and treatments; HF knowledge; mental and physical health, health distress, informational support, equipment usability, and quality of life. 2) For the caregiver: caregiver burden and health. 3) For the Health System: patient satisfaction, hospital, emergency \& provider visits, and mortality. Differential benefits for subsets of participants will be evaluated according to patient characteristics (socio-demographical, rurality, etc.). Evaluation of mediation variables will enhance our understanding of underlying processes. This research has the potential to revolutionize care for high-cost and high-need patients such as those with HF.
- Conditions
- Heart Failure
- Being tested
- Provider-Based Care Model Arm, mHealth Model Arm
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider-Based Care Model ArmOther
The PI will be supplementing standard care by providing and training each patient in the use of an analog (not internet connected) vital sign kit for 6 months: weight scale, blood pressure cuff, pulse oximeter. A Log for recording their vital sign measures.
mHealth Model ArmBehavioural
The PI will provide each patient with weight scale, blood pressure cuff, \& pulse oximeter kit connected to a Bluetooth-paired Android Health Tablet for 6 months. Daily vital sign readings will be sent to the secure cloud-based software. If the readings are out-of-range, the Registered Nurse Call Center will be automatically alerted and triaged.
| Study group | Role | What they receive |
|---|---|---|
| Provider-Based Care Model Arm | Active comparator | Non-connected home vital sign equipment will be given to patients in this group. The patients in the group will be instructed to record their daily readings on a paper log provided by the research team. These monitoring devices will not transmit readings to a centralized location and no one will be alerted to out-of-range readings or compliance with taking daily vital sign measures. At the front page of the log, normal ranges will be described with brief instructions about what participants/caregivers should do if their readings are out-of-range. Logs will be collected at baseline, 3-months and 6-months. Receives: Other: Provider-Based Care Model Arm |
| mHealth Model Arm | Experimental | Connected home vital sign equipment (mHealth) will be given to patients in this group. The patients will be instructed to take their daily readings, which will automatically be sent to the secure cloud-based software. If the readings are out-of-range, the Registered Nurse (RN) Call Center will be automatically alerted and the event will be triaged. Daily measures and medical follow-up from the measures will be counted and collected at baseline, 3-months, and 6-months. Receives: Behavioral: mHealth Model Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Care of Heart Failure Maintenance Scale (SCHFI)
self care scores on a scale range from 70 to 100, mean (SD). The SCHFI uses a Likert-type scale, with responses ranging from 1 (never) to 5 (always). The SCHFI also includes scales for self-care management and self-care confidence. Higher scores on the SCHFI indicate better self-care. A score of less than 70 on any of the subscales is considered inadequate self-care.
Measured: Change from Baseline, 3 months, and 6 months
Secondary outcomes (10)
Promis 43v2.1 Health Profile Anxiety 6a
subscale of questionnaire that measures anxiety. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/max range is 39.1-82.7
Measured: Change from Baseline, 3 months, and 6 months
Promis 43v2.1 Health Profile Depression 6a
subscale of questionnaire that measures depression. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 38.4-80.3
Measured: Change from Baseline, 3 months, and 6 months
Promis 43v2.1 Health Profile Fatigue 6a
subscale of questionnaire that measures fatigue. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 33.4-76.8
Measured: Change from Baseline, 3 months, and 6 months
Promis 43v2.1 Health Profile Pain Interference 6a
subscale of questionnaire that measures pain. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 41.1-76.3
Measured: Change from Baseline, 3 months, and 6 months
Promis 43v2.1 Health Profile Physical Function 6b
subscale of questionnaire that measures physical function. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 21.6-58.7
Measured: Change from Baseline, 3 months, and 6 months
Promis 43v2.1 Health Profile Sleep Disturbance 6a
subscale of questionnaire that measures sleep disturbance. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population Min/Max Range 31.7-76.1
Measured: Change from Baseline, 3 months, and 6 months
Promis 43v2.1 Health Profile Ability to Participate in Social Roles and Activities 6a
subscale of questionnaire that measures the ability to participate in social roles and activities . Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max Range 26.7-65
Measured: Change from Baseline, 3 months, and 6 months
Promis 43v2.1 Health Profile PROMIS Pain Intensity Item (Global07)
subscale of questionnaire that measures pain intensite. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 0-10
Measured: Change from Baseline, 3 months, and 6 months
Medical Outcomes Study MOS Health Distress Scale
questionnaire assesses psychological impact/health distress
Measured: Change from Baseline, 3 months, and 6 months
Minnesota Living With Heart Failure Questionnaire (MLHFQ)
questionnaire to assess quality of life. Scoring for the MLHFQ ranges from 0 to 105, the higher the score the more affected, over the past 4 months, the individual is by their heart failure.
Measured: Change from Baseline 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 posted11 Mar 2020
- Study start17 Nov 2020
- Primary completion25 Oct 2021
- Study completion25 Oct 2021
Why it stopped: Change in PI
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 Heart FailureStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The provider-directed management model is the current care standard for patients with HF; care delivery consists of office and emergency visits, with telephone or in person communications. The mHealth care management model consists of real time bio-monitoring kits and telemedicine visits using a secure wireless gateway with a cloud-based clinician portal connected to a Bluetooth-paired Android Tablet. Daily readings are transmitted to a 24-hour RN call center and triaged per protocols.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Judith L Weber, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304833
- Sponsor's protocol ID
- 260092
- Acronym
- I-COACH
- Status last verified
- Apr 2024
- First submitted
- 3 Mar 2020
- Last updated
- 10 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rhoads SJ, McSweeney J, Sadaka H, Jin J, Pirtle C, Sanford J. Experiences of Older Adults with Heart Failure Using Telemedicine During the COVID-19 Pandemic: A Qualitative Study. Telemed J E Health. 2025 Feb;31(2):191-199. doi: 10.1089/tmj.2024.0005. Epub 2024 Sep 30.
PubMed 39348299
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Care of Older Adults With Chronic Heart Failure (I-COACH): A Comparative Effectiveness Clinical Trial
- ClinicalTrials.gov ID
- NCT04304833
- Acronym / sponsor ID
- I-COACH / 260092
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in PI
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 11 Mar 2020 (actual)
- Results
- Posted 10 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An estimated 6.5 million adults in the U.S. have Heart Failure (HF) and the prevalence is increasing. HF is characterized by poor quality of life but this is amenable to self-management. However, the amount of support available from providers to help manage complications is far beyond what is feasible. The complex needs of these patients require a new vision for delivery of health care services, such as an mHealth management model. mHealth technologies such as blue-tooth enabled BP, heart rate, weight, and pulse oximetry remote monitoring permit sharing of immediate biometric data and video messages with providers and instantaneous feedback to patients before symptom crises, that is, when and where patients need it.
Detailed description
An estimated 6.5 million adults in the U.S. have Heart Failure (HF) and the prevalence is increasing. HF is characterized by poor quality of life but this is amenable to self-management. However, the amount of support available from providers to help manage complications is far beyond what is feasible. The complex needs of these patients require a new vision for delivery of health care services, such as an mHealth management model. mHealth technologies such as blue-tooth enabled BP, heart rate, weight, and pulse oximetry remote monitoring permit sharing of immediate biometric data and video messages with providers and instantaneous feedback to patients before symptom crises, that is, when and where patients need it.
This is a single-blinded comparative effectiveness randomized controlled trial conducted in a real-world setting. A sample of 400 dyads, that is older patients with HF (>55 years) and their caregivers, will be recruited from a large medical center and randomly assigned to one of two arms: 200 dyads to a provider-directed model or 200 dyads to the mHealth management model. The provider-directed management model is the current care standard for patients with HF; care delivery consists of office and emergency visits, with telephone or in person communications. The standard of care will be augmented by providing home equipment kits with weight scale, blood pressure, pulse oximetry devices and a Log to record data. The mHealth care management model consists of real time bio-monitoring kits and telemedicine visits using a secure wireless gateway with a cloud-based clinician portal connected to a Bluetooth-paired Android Tablet. Daily readings are transmitted to a 24-hour RN call center and triaged per protocols. Outcomes informed a prior by community stakeholders to be most important at the patient, caregiver, and health systems-levels will be collected and compared at baseline, 3- and 6- months: 1) For the patient: self-care of HF; confidence and self-efficacy to manage care, symptoms, medications and treatments; HF knowledge; mental and physical health, health distress, informational support, equipment usability, and quality of life. 2) For the caregiver: caregiver burden and health. 3) For the Health System: patient satisfaction, hospital, emergency \& provider visits, and mortality. Differential benefits for subsets of participants will be evaluated according to patient characteristics (socio-demographical, rurality, etc.). Evaluation of mediation variables will enhance our understanding of underlying processes. This research has the potential to revolutionize care for high-cost and high-need patients such as those with HF.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The provider-directed management model is the current care standard for patients with HF; care delivery consists of office and emergency visits, with telephone or in person communications. The mHealth care management model consists of real time bio-monitoring kits and telemedicine visits using a secure wireless gateway with a cloud-based clinician portal connected to a Bluetooth-paired Android Tablet. Daily readings are transmitted to a 24-hour RN call center and triaged per protocols.
| Arm | Type | Receives |
|---|---|---|
| Provider-Based Care Model Arm | Active comparator | Other: Provider-Based Care Model ArmNon-connected home vital sign equipment will be given to patients in this group. The patients in the group will be instructed to record their daily readings on a paper log provided by the research team. These monitoring devices will not transmit readings to a centralized location and no one will be alerted to out-of-range readings or compliance with taking daily vital sign measures. At the front page of the log, normal ranges will be described with brief instructions about what participants/caregivers should do if their readings are out-of-range. Logs will be collected at baseline, 3-months and 6-months. |
| mHealth Model Arm | Experimental | Behavioral: mHealth Model ArmConnected home vital sign equipment (mHealth) will be given to patients in this group. The patients will be instructed to take their daily readings, which will automatically be sent to the secure cloud-based software. If the readings are out-of-range, the Registered Nurse (RN) Call Center will be automatically alerted and the event will be triaged. Daily measures and medical follow-up from the measures will be counted and collected at baseline, 3-months, and 6-months. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged > 55 years with HF (documented in medical record).
- Has capacity to understand informed consent.
- Able to stand (briefly) without assistance.
- Has a designated caregiver.
- Agrees to be followed (treated) by UAMS physician/provider for 6 months after discharge.
Key exclusion criteria (3 listed)
- Speaks a language other than English or Spanish.
- Active psychosis or other severe cognitive disorder that interferes with capacity to understand and comply with study procedures.
- A history of drug or alcohol abuse in the past 90 days (documented in medical record).
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 |
|---|---|---|
| Provider-Based Care Model ArmThe PI will be supplementing standard care by providing and training each patient in the use of an analog (not internet connected) vital sign kit for 6 months: weight scale, blood pressure cuff, pulse oximeter. A Log for recording their vital sign measures. | Other | Provider-Based Care Model Arm |
| mHealth Model ArmThe PI will provide each patient with weight scale, blood pressure cuff, \& pulse oximeter kit connected to a Bluetooth-paired Android Health Tablet for 6 months. Daily vital sign readings will be sent to the secure cloud-based software. If the readings are out-of-range, the Registered Nurse Call Center will be automatically alerted and triaged. | Behavioural | mHealth Model Arm |
Primary outcome
Self-Care of Heart Failure Maintenance Scale (SCHFI)
Time frame: Change from Baseline, 3 months, and 6 months
self care scores on a scale range from 70 to 100, mean (SD). The SCHFI uses a Likert-type scale, with responses ranging from 1 (never) to 5 (always). The SCHFI also includes scales for self-care management and self-care confidence. Higher scores on the SCHFI indicate better self-care. A score of less than 70 on any of the subscales is considered inadequate self-care.
10 secondary outcomes
Promis 43v2.1 Health Profile Anxiety 6a
Time frame: Change from Baseline, 3 months, and 6 months
Promis 43v2.1 Health Profile Depression 6a
Time frame: Change from Baseline, 3 months, and 6 months
Promis 43v2.1 Health Profile Fatigue 6a
Time frame: Change from Baseline, 3 months, and 6 months
Promis 43v2.1 Health Profile Pain Interference 6a
Time frame: Change from Baseline, 3 months, and 6 months
Promis 43v2.1 Health Profile Physical Function 6b
Time frame: Change from Baseline, 3 months, and 6 months
Promis 43v2.1 Health Profile Sleep Disturbance 6a
Time frame: Change from Baseline, 3 months, and 6 months
Promis 43v2.1 Health Profile Ability to Participate in Social Roles and Activities 6a
Time frame: Change from Baseline, 3 months, and 6 months
Promis 43v2.1 Health Profile PROMIS Pain Intensity Item (Global07)
Time frame: Change from Baseline, 3 months, and 6 months
Medical Outcomes Study MOS Health Distress Scale
Time frame: Change from Baseline, 3 months, and 6 months
Minnesota Living With Heart Failure Questionnaire (MLHFQ)
Time frame: Change from Baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39348299Rhoads SJ, McSweeney J, Sadaka H, Jin J, Pirtle C, Sanford J. Experiences of Older Adults with Heart Failure Using Telemedicine During the COVID-19 Pandemic: A Qualitative Study. Telemed J E Health. 2025 Feb;31(2):191-199. doi: 10.1089/tmj.2024.0005. Epub 2024 Sep 30.
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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.
Judith L Weber, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider-Based Care Model Arm and mHealth Model Arm in people with Heart Failure, run by University of Arkansas 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 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: stopped early, as of the sponsor's last update on 10 Oct 2024. 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 10 Oct 2024). 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?
Self-Care of Heart Failure Maintenance Scale (SCHFI) (time frame: Change from Baseline, 3 months, and 6 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 NCT04304833, 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 10 Oct 2024.