Heart FailurePhase 2NCT03988621
Improving Self-care of Heart Failure Caregivers
A Phase 2 study testing ViCCY in people with Heart Failure, run by University of Pennsylvania at 1 site in United States.
Trial summary
Informal caregiving is demanding and stressful. Caregivers of adults with heart failure (HF) report significant stress and poor self-care. Health coaching, a support intervention, may relieve stress and promote self-care in HF caregivers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- ViCCY
- 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
- 343 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2019to 19 Oct 2023
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Informal caregiver of adults with heart failure providing care at least 8 hours/week, reporting poor self-care on screening (Health Self-Care Neglect scale score >=2 based on our pilot data), able to complete the protocol, e.g., adequate vision and hearing, and English speaking were required for enrollment.
Exclusion Criteria: Cognitive impairment (Telephone Interview for Cognitive Status [TICS] <25), Participation in another clinical trial of a support intervention, Untreated major psychiatric illness (Use of anti-anxiety/antidepressant medicines was acceptable and will be adjusted in analysis if group imbalance is identified).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Hospital Heart and Vascular Clinic
Philadelphia, Pennsylvania, 19104
About this study
Official title: Improving Self-Care of Informal Caregivers of Adults With Heart Failure
Informal caregiving is demanding and stressful. Caregivers of adults with heart failure (HF) report significant stress and poor self-care. Health coaching, a support intervention, may relieve stress and promote self-care in HF caregivers. Few studies have tested the cost-effectiveness of support interventions for caregivers. Even less is known about the effect of caregiver support interventions on HF outcomes. We developed and tested a virtual support intervention (ViCCY ("Vicky")-Virtual Caregiver Coach for you), in HF caregivers. Using randomized controlled trial (RCT) design, we enrolled informal HF caregivers with poor self-care (Health Self-Care Neglect scale score>=2), randomizing them 1:1 to an intervention or control group. Both groups received Health Information (HI) delivered through the Internet, but the ViCCY caregiver group also received 10 health coaching support sessions tailored to individual issues. The control group had access to the same HI resources over the same interval, using the same Internet program, but without coaching support. At baseline and 3, 6, 9, and 12 months, we collected self-reported data on self-care, stress, coping, and health status. At 6 months, we compared ViCCY to HI alone to assess intervention efficacy using intent-to-treat analysis. A sample of 250 caregivers (125/arm) was enrolled to provide >90% power to detect significant differences between the groups on the primary outcome of self-care (Aim 1). We collected quality adjusted life years (QALYs) and health care resource use in caregivers over 12 months to assess cost-effectiveness of ViCCY (Aim 2). To explore the effect of caregiver outcomes on HF patients' outcomes (hospitalization rates, hospital days, mortality rates, QALYs) over a 12-month period (Aim 3) and knowing that not all HF patients would enroll, we consented a subgroup of 93 HF patients cared for by these caregivers to explore the effect of caregiver self-care on patient outcomes. If shown to be efficacious and cost-effective, our virtual health coaching intervention can easily scaled to support millions of caregivers worldwide. This application addresses the NINR strategic plan and is directly responsive to PA-18-150.
Read the detailed description
We used a randomized controlled trial (RCT) design, randomizing informal heart failure (HF) caregivers meeting our inclusion and exclusion criteria 1:1 to an intervention or control group. After collecting baseline data, we block randomized the caregivers to achieve equal distribution of key variables in each condition. We will block randomize on caregiver sex (male/female), relationship to patient (e.g., spouse), and race. Sex and relationship are factors known to influence perceived caregiving burden and receptivity to intervention. Race was included to assure group balance. The randomization sequence was generated a priori by a statistician independent of the study investigators using a randomly permuted blocks algorithm to ensure equal distribution of these variables in each study arm. The Project Manager notified study staff and participants of their group assignment (intervention or control) by telephone, email or message, as preferred by the individual. Investigators and all staff involved in collecting assessment data were blinded to group assignment until after the data were locked. The health coach providing the intervention and the caregiver participants were not be blinded. All baseline data were collected prior to randomizing. Timing of follow-up assessments were based on day of randomization.
The study intervention was provided to individual caregivers. All caregivers (both groups) were provided with access to an Internet site with excellent health information (HI). The virtual support intervention (ViCCY ["Vicky"] - Virtual Caregiver Coach for You) was provided through tablet devices provided to caregivers in the intervention group. We provided tablets to all the caregivers, assuring that they had wireless network access so they can access the Internet site providing HI content. Caregivers in the control group received only HI but caregivers in the intervention group received 10 sessions of ViCCY over 6 months.
- Conditions
- Heart Failure
- Being tested
- ViCCY
- Keywords
- Self-care, Self-efficacy, Heart Failure, Stress, Support Systems
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViCCYBehavioural
Virtual Caregiver Coach for You
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Caregivers randomized to the intervention ViCCY received 10 sessions of virtual health coaching by trained health coaches over 6 months with content based on the theoretical framework (the Transactional Model of Stress and Coping) and prior research. In addition, they received the same health information as that provided to the caregivers in the control arm. Sessions were provided through tablets. We helped caregivers gain the knowledge and skills needed to achieve self-identified health goals through self-care using motivational interviewing. We focused on identifying personal values, solving problems, and transforming goals into action. ViCCY was standardized in a treatment manual. Because stress does not affect all people equally, the intervention was tailored to individual appraisals and the factors most likely to influence demand and perceived burden. Receives: Behavioral: ViCCY |
| Control | No intervention | The control group received Health Information (HI) delivered through the internet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Health Self-Care Neglect (HSCN) Scale
The Health Self-Care Neglect (HSCN) scale measures an individual's neglect of self-care behaviors. It consists of 9 yes or no questions. Scores range from 0-9. Higher scores indicating more self-care neglect.
Measured: The primary outcome was analyzed at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.
Change in the Self-Care Inventory, Maintenance Scale
The Self-Care Inventory is a 20 item inventory with 3 embedded scales (self-care maintenance, monitoring, and management). The outcome used in this study was the 8-item Self-Care Maintenance Scale. Responses are added and standardized to range from 0-100. A higher score indicates better self-care.
Measured: The primary outcome was analyzed at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.
Secondary outcomes (5)
Change in the Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS), a 14-item instrument that provides a global rating of an individual's belief in the severity and frequency of stressful experiences during the last month. The Perceived Stress Scale includes 14 items designed to assess symptoms of stress and global measures of the degree of stress experienced in the past month. Each item is scored from 0 (never) to 4 (very often), with total sum scores ranging from 0 to 56; higher scores indicate higher perceived stress. In prior test, Cronbach's alpha of the scale ranged from 0.84 to 0.86, and was 0.91 for older African American and European American females.
Measured: Main analysis was Baseline to 6 months. Data will be analyzed at 12 months to determine sustainability of intervention effect.
Change in the Ways of Coping Questionnaire
We used a 30-item modification of the original 42-item questionnaire developed by Lazarus in 1985. We measured these coping styles: active, avoidance, and minimization. The instrument uses a 4-point Likert-scale response format (0 = not used to 3 = used a great deal). Scores range from 0-45, 0-30, and 0-30 for the active, avoidance and minimization subscales, respectively. Higher scores indicate greater use of particular coping styles.
Measured: The primary analysis was at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.
Change in Health Status as Measured by the Short Form-36 (Physical and Mental Health Status)
Medical Outcomes Study Short Form (SF-36): measure of physical and mental health.The SF-36 has 36 items formatted in scales of varied format (3-, 5- and 6-pt scales and dichotomous [yes/no] scales). Each component score is standardized a 0-100 point scale. Higher values represent better health status. Reliability is varied samples is typically 0.80. Convergent and divergent validity have been demonstrated in various populations, including caregivers. A benefit of using the SF-36 is that it is one of the common data elements.
Measured: Main analysis Baseline to 6 months. Sustainability assessed at 12 months.
Change in the Caregivers' SF-6D (Short Form Six-dimension) Scores
The SF-6D uses preference weights derived from the SF-36. The Short-Form Six-Dimension (SF-6D) provides a way to use the SF-36 in economic evaluation by estimating a preference-based single index measure for health from these data using general population values. The SF-6D score represents caregiver quality of life at a given timepoint. Higher SF-6D Scores are better.
Measured: Measured at baseline, 3, 6, 9, and 12 months; primary analysis baseline to 12 months
Difference in Caregivers' Hospital and Provider Events
Healthcare resource use was self-reported by caregivers when they were telephoned at each follow-up period, asking about utilization since the last interview date. The self-reported healthcare use comprised 5 major categories: hospitalizations, emergency department (ED) visits, diagnostic and therapeutic procedures, ambulance services, and home care services. A bottom-up cost account approach was used, wherein the sum of resources times their unit price yielded the total costs associated with healthcare resource use. Unit prices were measured using the 2021 Medical Expenditure Panel Survey (MEPS) (https://meps.ahrq.gov/mepsweb), an annual survey on the financing and use of medical care in the United States collected by the Agency for Healthcare Research and Quality (AHRQ).
Measured: Data were collected at Baseline, 3, 6, 9, and 12 months. The primary analysis was done using the baseline to 12 month period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start23 Aug 2019
- Primary completion19 Apr 2023
- Study completion19 Oct 2023
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 (4)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 PennsylvaniaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was based on the Transactional Model of Stress and Coping. Stressful experiences such as caregiving demand - circumstances that give rise to real or perceived stress - are construed as person-environment transactions. Primary appraisal of demand involves assessment of its significance, which results in perceived burden. Secondary appraisal involves assessment of the resources available to cope with it. These appraisals lead to the coping effort. Without successful coping, self-care is poor, which decreases health status in caregivers. The virtual support intervention \[ViCCY ("Vicky") - Virtual Caregiver Coach for You\] addressed both appraisal and coping.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Riegel, PHD, RN, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988621
- Sponsor's protocol ID
- 1R01NR018196
- Status last verified
- Feb 2025
- First submitted
- 22 May 2019
- Last updated
- 20 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to share the data internally with doctoral students and post-doctoral trainees instead of sharing the data widely with external sources. Internal sharing will allow our trainees to complete meaningful studies using secondary analysis techniques and to finish their programs in a timely fashion. When all our analyses have been completed we will share the data through a public source.
Publications
Riegel B, Quinn R, Hirschman KB, Thomas G, Ashare R, Stawnychy MA, Bowles KH, Aryal S, Wald JW. Health Coaching Improves Outcomes of Informal Caregivers of Adults With Chronic Heart Failure: A Randomized Controlled Trial. Circ Heart Fail. 2024 Jul;17(7):e011475. doi: 10.1161/CIRCHEARTFAILURE.123.011475. Epub 2024 Jun 21.
PubMed 38904103Sun C, Hirschman KB, Matus A, Stawnychy MA, Goba M, Quinn R, Thomas G, Ashare R, Gordon D, Bowles KH, Riegel B, Coe NB. Cost-Effectiveness of Virtual Health Coaching for Caregivers of Patients With Heart Failure: Results From a Randomized Controlled Trial. J Am Heart Assoc. 2026 Aug 4;15(15):e040056. doi: 10.1161/JAHA.124.040056. Epub 2026 Jul 25.
PubMed 42500889Bidwell JT, Quinn R, Hirschman KB, Bowles KH, Thomas GL, Stawnychy MA, Matus A, Wald JW, Fauer AJ, Riegel B. Supporting Family Caregiver Health in Heart Failure: Longitudinal Associations Between Heart Failure Caregiver Self-Care and Patient Hospitalizations. J Card Fail. 2026 Mar 25:S1071-9164(26)00180-6. doi: 10.1016/j.cardfail.2026.03.023. Online ahead of print.
PubMed 41895678Riegel B, Quinn R, Hirschman KB. A longitudinal comparative analysis of sustained benefit of a self-care intervention for caregivers of adults with heart failure. BMC Nurs. 2025 Nov 22;24(1):1501. doi: 10.1186/s12912-025-04123-4.
PubMed 41272616
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Self-Care of Informal Caregivers of Adults With Heart Failure
- ClinicalTrials.gov ID
- NCT03988621
- Acronym / sponsor ID
- 1R01NR018196
- Conditions
- Heart Failure
- Keywords
- Self-care, Self-efficacy, Heart Failure, Stress, Support Systems
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 19 Oct 2023 (actual)
- First posted
- 17 Jun 2019 (actual)
- Results
- Posted 26 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Informal caregiving is demanding and stressful. Caregivers of adults with heart failure (HF) report significant stress and poor self-care. Health coaching, a support intervention, may relieve stress and promote self-care in HF caregivers. Few studies have tested the cost-effectiveness of support interventions for caregivers. Even less is known about the effect of caregiver support interventions on HF outcomes. We developed and tested a virtual support intervention (ViCCY ("Vicky")-Virtual Caregiver Coach for you), in HF caregivers. Using randomized controlled trial (RCT) design, we enrolled informal HF caregivers with poor self-care (Health Self-Care Neglect scale score>=2), randomizing them 1:1 to an intervention or control group. Both groups received Health Information (HI) delivered through the Internet, but the ViCCY caregiver group also received 10 health coaching support sessions tailored to individual issues. The control group had access to the same HI resources over the same interval, using the same Internet program, but without coaching support. At baseline and 3, 6, 9, and 12 months, we collected self-reported data on self-care, stress, coping, and health status. At 6 months, we compared ViCCY to HI alone to assess intervention efficacy using intent-to-treat analysis. A sample of 250 caregivers (125/arm) was enrolled to provide >90% power to detect significant differences between the groups on the primary outcome of self-care (Aim 1). We collected quality adjusted life years (QALYs) and health care resource use in caregivers over 12 months to assess cost-effectiveness of ViCCY (Aim 2). To explore the effect of caregiver outcomes on HF patients' outcomes (hospitalization rates, hospital days, mortality rates, QALYs) over a 12-month period (Aim 3) and knowing that not all HF patients would enroll, we consented a subgroup of 93 HF patients cared for by these caregivers to explore the effect of caregiver self-care on patient outcomes. If shown to be efficacious and cost-effective, our virtual health coaching intervention can easily scaled to support millions of caregivers worldwide. This application addresses the NINR strategic plan and is directly responsive to PA-18-150.
Detailed description
We used a randomized controlled trial (RCT) design, randomizing informal heart failure (HF) caregivers meeting our inclusion and exclusion criteria 1:1 to an intervention or control group. After collecting baseline data, we block randomized the caregivers to achieve equal distribution of key variables in each condition. We will block randomize on caregiver sex (male/female), relationship to patient (e.g., spouse), and race. Sex and relationship are factors known to influence perceived caregiving burden and receptivity to intervention. Race was included to assure group balance. The randomization sequence was generated a priori by a statistician independent of the study investigators using a randomly permuted blocks algorithm to ensure equal distribution of these variables in each study arm. The Project Manager notified study staff and participants of their group assignment (intervention or control) by telephone, email or message, as preferred by the individual. Investigators and all staff involved in collecting assessment data were blinded to group assignment until after the data were locked. The health coach providing the intervention and the caregiver participants were not be blinded. All baseline data were collected prior to randomizing. Timing of follow-up assessments were based on day of randomization.
The study intervention was provided to individual caregivers. All caregivers (both groups) were provided with access to an Internet site with excellent health information (HI). The virtual support intervention (ViCCY ["Vicky"] - Virtual Caregiver Coach for You) was provided through tablet devices provided to caregivers in the intervention group. We provided tablets to all the caregivers, assuring that they had wireless network access so they can access the Internet site providing HI content. Caregivers in the control group received only HI but caregivers in the intervention group received 10 sessions of ViCCY over 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study was based on the Transactional Model of Stress and Coping. Stressful experiences such as caregiving demand - circumstances that give rise to real or perceived stress - are construed as person-environment transactions. Primary appraisal of demand involves assessment of its significance, which results in perceived burden. Secondary appraisal involves assessment of the resources available to cope with it. These appraisals lead to the coping effort. Without successful coping, self-care is poor, which decreases health status in caregivers. The virtual support intervention [ViCCY ("Vicky") - Virtual Caregiver Coach for You] addressed both appraisal and coping.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: ViCCYCaregivers randomized to the intervention ViCCY received 10 sessions of virtual health coaching by trained health coaches over 6 months with content based on the theoretical framework (the Transactional Model of Stress and Coping) and prior research. In addition, they received the same health information as that provided to the caregivers in the control arm. Sessions were provided through tablets. We helped caregivers gain the knowledge and skills needed to achieve self-identified health goals through self-care using motivational interviewing. We focused on identifying personal values, solving problems, and transforming goals into action. ViCCY was standardized in a treatment manual. Because stress does not affect all people equally, the intervention was tailored to individual appraisals and the factors most likely to influence demand and perceived burden. |
| Control | No intervention | –The control group received Health Information (HI) delivered through the internet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| ViCCYVirtual Caregiver Coach for You | Behavioural | Intervention |
Primary outcome
Change in the Health Self-Care Neglect (HSCN) Scale
Time frame: The primary outcome was analyzed at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.
The Health Self-Care Neglect (HSCN) scale measures an individual's neglect of self-care behaviors. It consists of 9 yes or no questions. Scores range from 0-9. Higher scores indicating more self-care neglect.
Change in the Self-Care Inventory, Maintenance Scale
Time frame: The primary outcome was analyzed at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.
The Self-Care Inventory is a 20 item inventory with 3 embedded scales (self-care maintenance, monitoring, and management). The outcome used in this study was the 8-item Self-Care Maintenance Scale. Responses are added and standardized to range from 0-100. A higher score indicates better self-care.
5 secondary outcomes
Change in the Perceived Stress Scale (PSS)
Time frame: Main analysis was Baseline to 6 months. Data will be analyzed at 12 months to determine sustainability of intervention effect.
Change in the Ways of Coping Questionnaire
Time frame: The primary analysis was at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.
Change in Health Status as Measured by the Short Form-36 (Physical and Mental Health Status)
Time frame: Main analysis Baseline to 6 months. Sustainability assessed at 12 months.
Change in the Caregivers' SF-6D (Short Form Six-dimension) Scores
Time frame: Measured at baseline, 3, 6, 9, and 12 months; primary analysis baseline to 12 months
Difference in Caregivers' Hospital and Provider Events
Time frame: Data were collected at Baseline, 3, 6, 9, and 12 months. The primary analysis was done using the baseline to 12 month period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38904103Riegel B, Quinn R, Hirschman KB, Thomas G, Ashare R, Stawnychy MA, Bowles KH, Aryal S, Wald JW. Health Coaching Improves Outcomes of Informal Caregivers of Adults With Chronic Heart Failure: A Randomized Controlled Trial. Circ Heart Fail. 2024 Jul;17(7):e011475. doi: 10.1161/CIRCHEARTFAILURE.123.011475. Epub 2024 Jun 21.
- Derived from this study: PubMed 42500889Sun C, Hirschman KB, Matus A, Stawnychy MA, Goba M, Quinn R, Thomas G, Ashare R, Gordon D, Bowles KH, Riegel B, Coe NB. Cost-Effectiveness of Virtual Health Coaching for Caregivers of Patients With Heart Failure: Results From a Randomized Controlled Trial. J Am Heart Assoc. 2026 Aug 4;15(15):e040056. doi: 10.1161/JAHA.124.040056. Epub 2026 Jul 25.
- Derived from this study: PubMed 41895678Bidwell JT, Quinn R, Hirschman KB, Bowles KH, Thomas GL, Stawnychy MA, Matus A, Wald JW, Fauer AJ, Riegel B. Supporting Family Caregiver Health in Heart Failure: Longitudinal Associations Between Heart Failure Caregiver Self-Care and Patient Hospitalizations. J Card Fail. 2026 Mar 25:S1071-9164(26)00180-6. doi: 10.1016/j.cardfail.2026.03.023. Online ahead of print.
- Derived from this study: PubMed 41272616Riegel B, Quinn R, Hirschman KB. A longitudinal comparative analysis of sustained benefit of a self-care intervention for caregivers of adults with heart failure. BMC Nurs. 2025 Nov 22;24(1):1501. doi: 10.1186/s12912-025-04123-4.
- Individual participant dataSharing planned: Yes. Plan to share the data internally with doctoral students and post-doctoral trainees instead of sharing the data widely with external sources. Internal sharing will allow our trainees to complete meaningful studies using secondary analysis techniques and to finish their programs in a timely fashion. When all our analyses have been completed we will share the data through a public source.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ViCCY in people with Heart Failure, run by University of Pennsylvania 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?
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 20 Feb 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 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?
Change in the Health Self-Care Neglect (HSCN) Scale (time frame: The primary outcome was analyzed at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.). The study lists 2 primary outcomes in all. 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 NCT03988621, which also lists 4 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 20 Feb 2025.