Adapting and Implementing the I-HoME Intervention in Caregivers of Patients With ADRD

NCT06488157 | Completed Results

• 2 other identifiers: 23-01025643K76AG059997-04S1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Caregiver Burden

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  Baseline, 2, 4, 6, 8, 10, 12 weeks

• Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8

  Baseline, 2, 4, 6, 8, 10, 12 week

• Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7

  Baseline, 2, 4, 6, 8, 10, 12 weeks

• Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version

  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

  Baseline, 2, 4, 6, 8, 10, 12 weeks

Study Arms (1)

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.

Other: I-HoME

Interventions

I-HoME OTHER

Video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs

Intervention (I-HoME)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-English speaking
• \<18 years old or \>100 years old

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Veerawat Phongtankuel
• Organization: Weill Cornell Medicine

vep9012@med.cornell.edu

212-746-7000

Study Officials

• Veerawat Phongtankuel, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: July 10, 2024
• Primary Completion: May 23, 2025
• Study Completion: May 23, 2025
• Last Updated: August 27, 2025
• Results First Posted: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)