Caregiver BurdenNCT06488157
Adapting and Implementing the I-HoME Intervention in Caregivers of Patients With ADRD
A study testing I-HoME in people with Caregiver Burden, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to pilot test the adapted Improving Home hospice Management of End-of-life issues through technology (I-HoME) intervention with family caregivers of patients with advanced Alzheimer's Disease and related dementia. Data will be collected regarding intervention feasibility and acceptability. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- I-HoME
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2024to 23 May 2025
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old and < 100 years
- English speaking
- Providing care to an ADRD patient who is age ≥ 65 years old and < 105 years who is a stage 7a-f on the Functional Assessment Staging Tool (FAST) scale
Who cannot join
- Non-English speaking
- <18 years old or >100 years old
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to pilot test the adapted Improving Home hospice Management of End-of-life issues through technology (I-HoME) intervention with family caregivers of patients with advanced Alzheimer's Disease and related dementia. Data will be collected regarding intervention feasibility and acceptability.
- Conditions
- Caregiver Burden
- Being tested
- I-HoME
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-HoMEOther
Video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs
| Study group | Role | What they receive |
|---|---|---|
| Intervention (I-HoME) | Experimental | Participants receive video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs. Receives: Other: I-HoME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, as Measured by the Percentage of Caregivers Who Enroll in the Study
Feasibility was measured by the percentage of caregivers who enrolled in the study out of all eligible participants.
Measured: Recruitment (7 months)
Feasibility, as Measured by the Percentage of Tele-visits Conducted
Feasibility was measured by dividing the number of tele-visits conducted by the number of tele-visits that could have been conducted, then multiplying by 100. This measure shows the adherence of the intervention arm to the tele-visits. The percentage is calculated for the group rather than the individual patient.
Measured: At the end of the intervention or at 12 weeks, whichever is earlier
Secondary outcomes (5)
Change in Behavioral and Psychosocial Symptoms of Dementia (BPSD) in the Patient, as Measured by the Neuropsychiatric Inventory Questionnaire
Change in behavioral and psychosocial symptoms of dementia (BPSD) in the patient, as measured by the Neuropsychiatric Inventory Questionnaire. Scale is from 0 to 36, with higher scores indicating more severe BPSD.
Measured: Baseline, 2, 4, 6, 8, 10, 12 weeks
Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8
Mean caregiver depression score, as measured by Patient Health Questionnaire-8. Scale is from 0 to 24, with higher scores indicating more severe depression.
Measured: Baseline, 2, 4, 6, 8, 10, 12 week
Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7
Mean caregiver anxiety score, as measured by General Anxiety Disorder-7. Scale is from 0 to 21, with higher scores indicating more severe anxiety.
Measured: Baseline, 2, 4, 6, 8, 10, 12 weeks
Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version
Mean caregiver burden score, as measured by the Zarit Burden Interview - short version. Scale is from 0 to 48, with higher scores indicating higher caregiver burden.
Measured: Baseline, 2, 4, 6, 8, 10, 12 weeks
Mean Caregiver Perception of Patient's Pain Score, as Measured by the Doloplus 2 Scale Behavioral Assessment
Mean caregiver perception of patient's pain score, as measured by the Doloplus 2 Scale behavioral assessment. Scale is from 0 to 30, with higher scores indicating greater pain.
Measured: Baseline, 2, 4, 6, 8, 10, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start10 Jul 2024
- Primary completion23 May 2025
- Study completion23 May 2025
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 Caregiver BurdenStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Veerawat Phongtankuel, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488157
- Sponsor's protocol ID
- 23-01025643
- Other IDs
- K76AG059997-04S1
- Status last verified
- Aug 2025
- First submitted
- 28 Jun 2024
- Last updated
- 27 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Phongtankuel V, Ballin M, Moxley J, Park T, Toliver MD, Chuquitarco G, Czaja SJ, Adelman RD, Liao V, Reid MC. A Dual-Component Nurse Practitioner Intervention to Improve Symptom Management for Caregivers of Persons Living With Dementia: A Pilot Study. J Hosp Palliat Nurs. 2026 Dec 1;28(6):E285-E290. doi: 10.1097/NJH.0000000000001232. Epub 2026 Aug 22.
PubMed 42631925
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting and Implementing the I-HoME Intervention in Caregivers of Patients With ADRD
- ClinicalTrials.gov ID
- NCT06488157
- Acronym / sponsor ID
- 23-01025643
- Conditions
- Caregiver Burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 5 Jul 2024 (actual)
- Results
- Posted 27 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to pilot test the adapted Improving Home hospice Management of End-of-life issues through technology (I-HoME) intervention with family caregivers of patients with advanced Alzheimer's Disease and related dementia. Data will be collected regarding intervention feasibility and acceptability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention (I-HoME) | Experimental | Other: I-HoMEParticipants receive video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old and < 100 years
- English speaking
- Providing care to an ADRD patient who is age ≥ 65 years old and < 105 years who is a stage 7a-f on the Functional Assessment Staging Tool (FAST) scale
Key exclusion criteria (2 listed)
- Non-English speaking
- <18 years old or >100 years old
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 |
|---|---|---|
| I-HoMEVideo visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs | Other | Intervention (I-HoME) |
Primary outcome
Feasibility, as Measured by the Percentage of Caregivers Who Enroll in the Study
Time frame: Recruitment (7 months)
Feasibility was measured by the percentage of caregivers who enrolled in the study out of all eligible participants.
Feasibility, as Measured by the Percentage of Tele-visits Conducted
Time frame: At the end of the intervention or at 12 weeks, whichever is earlier
Feasibility was measured by dividing the number of tele-visits conducted by the number of tele-visits that could have been conducted, then multiplying by 100. This measure shows the adherence of the intervention arm to the tele-visits. The percentage is calculated for the group rather than the individual patient.
5 secondary outcomes
Change in Behavioral and Psychosocial Symptoms of Dementia (BPSD) in the Patient, as Measured by the Neuropsychiatric Inventory Questionnaire
Time frame: Baseline, 2, 4, 6, 8, 10, 12 weeks
Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8
Time frame: Baseline, 2, 4, 6, 8, 10, 12 week
Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7
Time frame: Baseline, 2, 4, 6, 8, 10, 12 weeks
Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version
Time frame: Baseline, 2, 4, 6, 8, 10, 12 weeks
Mean Caregiver Perception of Patient's Pain Score, as Measured by the Doloplus 2 Scale Behavioral Assessment
Time frame: Baseline, 2, 4, 6, 8, 10, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42631925Phongtankuel V, Ballin M, Moxley J, Park T, Toliver MD, Chuquitarco G, Czaja SJ, Adelman RD, Liao V, Reid MC. A Dual-Component Nurse Practitioner Intervention to Improve Symptom Management for Caregivers of Persons Living With Dementia: A Pilot Study. J Hosp Palliat Nurs. 2026 Dec 1;28(6):E285-E290. doi: 10.1097/NJH.0000000000001232. Epub 2026 Aug 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veerawat Phongtankuel, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-HoME in people with Caregiver Burden, run by Weill Medical College of Cornell University 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 3 inclusion and 2 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 27 Aug 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2025). 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?
Feasibility, as Measured by the Percentage of Caregivers Who Enroll in the Study (time frame: Recruitment (7 months)). 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 NCT06488157, 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 27 Aug 2025.