Caregiver StressPhase 3iCare4Me TNCT06167746
iCare4Me Transitions
A Phase 3 study testing Digital Health Information (DHI) and Virtual Health Coach for You in people with Caregiver Stress, run by University of Pennsylvania at 3 sites in United States.
Trial summary
The goal of this randomized controlled trial is to examine the effect of a virtual face-to-face health coach intervention to improve self-care among caregivers of hospitalized older adults during care transitions compared to web-based resource information alone to determine the effectiveness of each intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Stress
- What is being tested?
- Digital Health Information (DHI) and Virtual Health Coach for You
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Mar 2024to 31 May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Informal caregiver providing care at least 8 hours/week to the hospitalized older adult (age 65 or older)
- Reporting poor self-care on screening (Health Self-Care Neglect scale score greater than or equal to 2)
- Willing to use technology (e.g., computer, smartphone, iPad/tablet)
- Able to complete the protocol, e.g., adequate vision and hearing
- English speaking
Who cannot join
- Cognitive deficits in orientation and/or recall (Six Item Screener score less than 3)
- Participation in another similar support or care transition trial
- Untreated major psychiatric illness (Use of anti-anxiety or anti-depressant medicines is acceptable)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104-4212
Karen Hirschman, PhD MSW FGSA, 215-573-3755, hirschk@nursing.upenn.edu
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Karen Hirschman, PhD, 215-573-3755, hirschk@nursing.upenn.edu
- Recruiting
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Karen Hirschman, PhD, MSW, 215-573-3755, hirschk@nursing.upenn.edu
About this study
Official title: Improving Care Transitions and Self-care Among Informal Caregivers of Hospitalized Older Adults Through Digital Tools
The goal of this randomized controlled trial is to examine the effect of a virtual face-to-face health coach intervention to improve self-care among caregivers of hospitalized older adults during care transitions compared to web-based resource information alone to determine the effectiveness of each intervention. The main questions it aims to answer are:
- compare the efficacy of the virtual health coaching intervention vs. web-based information alone in improving self-care in caregivers of hospitalized community-dwelling older adults with multiple chronic conditions (MCCs) who transition from hospital to home,
- compare outcomes among Black/African American and White caregivers who receive the intervention vs. digital health information alone, and
- explore the estimated the cost of the interventions and acute care resource use among patients of caregivers who received virtual intervention vs. digital health information alone.
Read more
Participants who enroll will agree to enroll will:
- be randomly assigned to either the health information group or the health coaching intervention plus health information group for six months, and
- be asked to complete a baseline interview, a check-in call at one month post-hospital discharge, and two follow-up interviews at 3- and 6-months after enrollment.
Researchers will compare the two groups of caregivers on the following outcomes: self-care, caregiver self-efficacy (aka confidence), coping, stress, and health status.
- Conditions
- Caregiver Stress
- Being tested
- Digital Health Information (DHI), Virtual Health Coach for You
- Keywords
- Care Transitions, Older Adult, Health Coaching, Virtual, Self-Care, Coping
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Health Information (DHI)Other
Digital health information websites.
Virtual Health Coach for YouBehavioural
Also called ViCCY
Study participants in the intervention group will receive 10-session virtual health coaching intervention session delivered over 6 months with the goal of improving caregiver self-care and coping, decreasing stress, and improving the hospital-to-home experience The 10 sessions are on average 60 minutes and cover the following topics: care transitions, caregiving demand, self-care, and coping.
| Study group | Role | What they receive |
|---|---|---|
| Digital Health Information (DHI) | Active comparator | Digital health information is delivered through a website tailored with care transitions and self-care information for all participants over the 6-month study. Receives: Other: Digital Health Information (DHI) |
| Virtual Health Coaching + DHI | Experimental | Study participants in the intervention group will receive 10-session virtual health coaching intervention sessions delivered over 6 months. Receives: Other: Digital Health Information (DHI); Behavioral: Virtual Health Coach for You |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Care Inventory
The Self-Care Inventory (SCI) measures self-care maintenance, monitoring, management, and self-efficacy. Each subscale is standardized on a 0-100 point scale. Higher scores indicate better self-care.
Measured: Collected at: enrollment, 3- and 6-months after enrollment
Health Self-Care Neglect
This a binary that scale captures the level of self-care neglect, with higher scores indicating greater neglect.
Measured: Collected at: enrollment, 3- and 6-months after enrollment
Secondary outcomes (6)
Perceived Stress Scale
The perceived stress scale has 10 items rated on a 5-point scale rating perceptions of stress.
Measured: Collected at: enrollment, 3- and 6-months after enrollment
Brief COPE
This tool is designed to assess the varying coping strategies used by individuals in response to stress.
Measured: Collected at: enrollment, 3- and 6-months after enrollment
Caregiver Self-Care Self-Efficacy Scale
This scale measures caregiving self-efficacy in multiple areas. Each item is measured on a scale of 1-5 with 5 indicating they are the most confident in that area.
Measured: Collected at: enrollment, 3- and 6-months after enrollment
Preparedness for Caregiving Scale
This scale measures how prepared caregivers feel to provide support for their loved ones in multiple areas. Each item is measured on a scale of 0-4 with 4 indicating they are the most prepared in that area.
Measured: Collected at: enrollment, 3- and 6-months after enrollment
Quality of the relationship
This scale measures giving and receiving support in multiple areas. Each item is measured on a scale of 0-4 with 4 indicating they are the most positive in that area.
Measured: Collected at: enrollment, 3- and 6-months after enrollment
RAND Medical Outcomes Study Short Form (SF-36)
This scale that uses multiple measures to determine overall mental and physical health. Higher scores indicate better mental and physical health.
Measured: Collected at: enrollment, 3- and 6-months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Mar 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver StressStudies 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This randomized single-group interventional study caregivers of recently hospitalized older adults will receive either digital health information (DHI) alone or a virtual health coaching intervention (Virtual Caregiver Coach for You, ViCCY) with DHI. Health resource data on the patients of the enrolled caregivers will be collected.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Karen Hirschman, Ph.D., Principal investigator, University of Pennsylvia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167746
- Sponsor's protocol ID
- R01AG082892
- Other IDs
- 1R01AG082892-01
- Acronym
- iCare4Me T
- Status last verified
- Mar 2026
- First submitted
- 4 Dec 2023
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant self-report data collected during the trial that underlie the results of the primary outcome will be shared after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care Transitions and Self-care Among Informal Caregivers of Hospitalized Older Adults Through Digital Tools
- ClinicalTrials.gov ID
- NCT06167746
- Acronym / sponsor ID
- iCare4Me T / R01AG082892
- Conditions
- Caregiver Stress
- Keywords
- Care Transitions, Older Adult, Health Coaching, Virtual, Self-Care, Coping
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 12 Dec 2023 (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.
The goal of this randomized controlled trial is to examine the effect of a virtual face-to-face health coach intervention to improve self-care among caregivers of hospitalized older adults during care transitions compared to web-based resource information alone to determine the effectiveness of each intervention. The main questions it aims to answer are:
- compare the efficacy of the virtual health coaching intervention vs. web-based information alone in improving self-care in caregivers of hospitalized community-dwelling older adults with multiple chronic conditions (MCCs) who transition from hospital to home,
- compare outcomes among Black/African American and White caregivers who receive the intervention vs. digital health information alone, and
- explore the estimated the cost of the interventions and acute care resource use among patients of caregivers who received virtual intervention vs. digital health information alone.
Participants who enroll will agree to enroll will:
- be randomly assigned to either the health information group or the health coaching intervention plus health information group for six months, and
- be asked to complete a baseline interview, a check-in call at one month post-hospital discharge, and two follow-up interviews at 3- and 6-months after enrollment.
Researchers will compare the two groups of caregivers on the following outcomes: self-care, caregiver self-efficacy (aka confidence), coping, stress, and health status.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This randomized single-group interventional study caregivers of recently hospitalized older adults will receive either digital health information (DHI) alone or a virtual health coaching intervention (Virtual Caregiver Coach for You, ViCCY) with DHI. Health resource data on the patients of the enrolled caregivers will be collected.
| Arm | Type | Receives |
|---|---|---|
| Digital Health Information (DHI) | Active comparator | Other: Digital Health Information (DHI)Digital health information is delivered through a website tailored with care transitions and self-care information for all participants over the 6-month study. |
| Virtual Health Coaching + DHI | Experimental | Other: Digital Health Information (DHI), Behavioral: Virtual Health Coach for YouStudy participants in the intervention group will receive 10-session virtual health coaching intervention sessions delivered over 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informal caregiver providing care at least 8 hours/week to the hospitalized older adult (age 65 or older)
- Reporting poor self-care on screening (Health Self-Care Neglect scale score greater than or equal to 2)
- Willing to use technology (e.g., computer, smartphone, iPad/tablet)
- Able to complete the protocol, e.g., adequate vision and hearing
- English speaking
Key exclusion criteria (3 listed)
- Cognitive deficits in orientation and/or recall (Six Item Screener score less than 3)
- Participation in another similar support or care transition trial
- Untreated major psychiatric illness (Use of anti-anxiety or anti-depressant medicines is acceptable)
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 |
|---|---|---|
| Digital Health Information (DHI)Digital health information websites. | Other | Digital Health Information (DHI), Virtual Health Coaching + DHI |
| Virtual Health Coach for YouAlso: ViCCYStudy participants in the intervention group will receive 10-session virtual health coaching intervention session delivered over 6 months with the goal of improving caregiver self-care and coping, decreasing stress, and improving the hospital-to-home experience The 10 sessions are on average 60 minutes and cover the following topics: care transitions, caregiving demand, self-care, and coping. | Behavioural | Virtual Health Coaching + DHI |
Primary outcome
Self-Care Inventory
Time frame: Collected at: enrollment, 3- and 6-months after enrollment
The Self-Care Inventory (SCI) measures self-care maintenance, monitoring, management, and self-efficacy. Each subscale is standardized on a 0-100 point scale. Higher scores indicate better self-care.
Health Self-Care Neglect
Time frame: Collected at: enrollment, 3- and 6-months after enrollment
This a binary that scale captures the level of self-care neglect, with higher scores indicating greater neglect.
6 secondary outcomes
Perceived Stress Scale
Time frame: Collected at: enrollment, 3- and 6-months after enrollment
Brief COPE
Time frame: Collected at: enrollment, 3- and 6-months after enrollment
Caregiver Self-Care Self-Efficacy Scale
Time frame: Collected at: enrollment, 3- and 6-months after enrollment
Preparedness for Caregiving Scale
Time frame: Collected at: enrollment, 3- and 6-months after enrollment
Quality of the relationship
Time frame: Collected at: enrollment, 3- and 6-months after enrollment
RAND Medical Outcomes Study Short Form (SF-36)
Time frame: Collected at: enrollment, 3- and 6-months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: Yes. Individual participant self-report data collected during the trial that underlie the results of the primary outcome will be shared after de-identification.
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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.
Karen Hirschman, Ph.D. principal investigator
University of Pennsylvia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Digital Health Information (DHI) and Virtual Health Coach for You in people with Caregiver Stress, run by University of Pennsylvania at 3 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 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: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Hirschman, Ph.D. (215-573-3755, hirschk@nursing.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Care Inventory (time frame: Collected at: enrollment, 3- and 6-months after enrollment). 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?
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 12 Mar 2026.