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

Not Applicable

Recruiting

• Conditions: Caregiver Burden
• Interventions: Other: I-HoME

• Registration Number: NCT06488157
• Lead Sponsor: Weill Medical College of Cornell University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-06-28
• Study First Posted: 2024-07-05
• Study Start: 2024-07-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention (I-HoME)	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.

Primary Outcome Measures

Name	Time	Method
Feasibility, as measured by the percentage of participants who complete their telehealth visits	At the end of the intervention or at 12 weeks, whichever is earlier
Feasibility, as measured by the percentage of caregivers who enroll in the study	Day 1

Secondary Outcome Measures

Name	Time	Method
Change in caregiver burden, as measured by the Zarit Burden Interview - short version	Baseline, 2, 4, 6, 8, 10, 12 weeks	Change in caregiver burden, as measured by the Zarit Burden Interview - short version. Scale is from 0 to 48, with higher scores indicating higher caregiver burden.
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	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.
Change in caregiver depression, as measured by Patient Health Questionnaire-8	Baseline, 2, 4, 6, 8, 10, 12 weeks	Change in caregiver depression, as measured by Patient Health Questionnaire-8. Scale is from 0 to 24, with higher scores indicating more severe depression.
Change in caregiver anxiety, as measured by General Anxiety Disorder-7	Baseline, 2, 4, 6, 8, 10, 12 weeks	Change in caregiver anxiety, as measured by General Anxiety Disorder-7. Scale is from 0 to 21, with higher scores indicating more severe anxiety.
Change in caregiver perception of patient's pain, as measured by the Doloplus 2 Scale behavioral assessment	Baseline, 2, 4, 6, 8, 10, 12 weeks	Change in caregiver perception of patient's pain, as measured by the Doloplus 2 Scale behavioral assessment. Scale is from 0 to 30, with higher scores indicating greater pain.

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States