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Completed

NCT Number: NCT06488157

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.

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Key information

Conditions

Caregiver Burden Behavior Behavioral Symptoms Stress, Psychological

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

I-HoME

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

    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.

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

    Time frame: 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.

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

    Time frame: 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.

  4. 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 burden score, as measured by the Zarit Burden Interview - short version. Scale is from 0 to 48, with higher scores indicating higher caregiver burden.

  5. 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

    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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 5, 2024
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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