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

Not Applicable

Completed

• Conditions: Caregiver Burden

• 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
• Primary Completion: 2025-05-23
• Study Completion: 2025-05-23
• Results First Submitted: 2025-07-29
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-25
• Last Update Submitted: 2025-08-25
• Results First Posted: 2025-08-27
• Last Update Posted: 2025-08-27

Recruitment & Eligibility

• Status: COMPLETED
• 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

Primary Outcome Measures

Name	Time	Method
Feasibility, as Measured by the Percentage of Caregivers Who Enroll in the Study	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	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.

Secondary Outcome Measures

Name	Time	Method
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.
Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8	Baseline, 2, 4, 6, 8, 10, 12 week	Mean caregiver depression score, as measured by Patient Health Questionnaire-8. Scale is from 0 to 24, with higher scores indicating more severe depression.
Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7	Baseline, 2, 4, 6, 8, 10, 12 weeks	Mean caregiver anxiety score, as measured by General Anxiety Disorder-7. Scale is from 0 to 21, with higher scores indicating more severe anxiety.
Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version	Baseline, 2, 4, 6, 8, 10, 12 weeks	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.
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	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.

Trial Locations

Locations (1)

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