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

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 Overview

• Status: Completed
• Conditions: Caregiver Burden
• Intervention / Treatment: Other: I-HoME

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention (I-HoME); 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; Video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Baseline, 2, 4, 6, 8, 10, 12 weeks

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Veerawat Phongtankuel, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Actual): May 23, 2025
• Study Completion (Actual): May 23, 2025

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Behavior; Caregiver Burden
• Other Study ID Numbers: 23-01025643; K76AG059997-04S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No