Caregiver Burden
Conditions
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.
Interventions
OTHERI-HoME
Video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs
Sponsors
National Institute on Aging (NIA)
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
I-HoME: Video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Intervention (I-HoME) |
|---|---|
| Age, Continuous | 68.1 years STANDARD_DEVIATION 12.93 |
| Annual Household Income Range $25,000 or less | 0 Participants |
| Annual Household Income Range $25,001 to $50,000 | 1 Participants |
| Annual Household Income Range $50,001 to $75,000 | 2 Participants |
| Annual Household Income Range $75,001 or greater | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Highest Education Completed College degree | 1 Participants |
| Highest Education Completed Graduate Degree | 12 Participants |
| Highest Education Completed High School or GED | 0 Participants |
| Highest Education Completed Post-graduate but no degree | 0 Participants |
| Highest Education Completed Some College | 2 Participants |
| Highest Education Completed Some high school | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 15 Participants |
| Relationship to Patient Child | 10 Participants |
| Relationship to Patient Friend | 0 Participants |
| Relationship to Patient Paid Caregiver | 0 Participants |
| Relationship to Patient Relative | 1 Participants |
| Relationship to Patient Spouse/partner | 4 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
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.
Time frame: Recruitment (7 months)
Population: All participants who we reached out to and were eligible for our study, including those who refused to participate or were unreachable over multiple attempts, were included in the number of participants analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Feasibility, as Measured by the Percentage of Caregivers Who Enroll in the Study | 37 percentage of all eligible participants |
Primary
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.
Time frame: At the end of the intervention or at 12 weeks, whichever is earlier
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Feasibility, as Measured by the Percentage of Tele-visits Conducted | 95.5 percentage of tele-visits conducted |
Secondary
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.
Time frame: Baseline, 2, 4, 6, 8, 10, 12 weeks
Population: This measure was not collected because, after completing the first phase of the study, we found it was not relevant to the participants in the clinical trial.
Secondary
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.
Time frame: Baseline, 2, 4, 6, 8, 10, 12 weeks
Population: The number of participants analyzed at each time point varied because:~A caregiver was ineligible to participate due to their care recipient passing away.~A caregiver missed the tele-visit session on that particular week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7 | Baseline | 5.9 score on a scale | Standard Deviation 3.25 |
| All Participants | Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7 | Week 2 | 5.0 score on a scale | Standard Deviation 4.17 |
| All Participants | Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7 | Week 4 | 4.3 score on a scale | Standard Deviation 3.77 |
| All Participants | Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7 | Week 6 | 3.9 score on a scale | Standard Deviation 3.96 |
| All Participants | Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7 | Week 8 | 4.7 score on a scale | Standard Deviation 4.94 |
| All Participants | Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7 | Week 10 | 5.0 score on a scale | Standard Deviation 4.49 |
| All Participants | Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7 | Week 12 | 3.4 score on a scale | Standard Deviation 3.33 |
Secondary
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.
Time frame: Baseline, 2, 4, 6, 8, 10, 12 weeks
Population: The number of participants analyzed at each time point varied because:~A caregiver was ineligible to participate due to their care recipient passing away.~A caregiver missed the tele-visit session on that particular week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version | Baseline | 16.6 score on a scale | Standard Deviation 6.54 |
| All Participants | Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version | Week 2 | 12.1 score on a scale | Standard Deviation 7.43 |
| All Participants | Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version | Week 4 | 10.1 score on a scale | Standard Deviation 5.9 |
| All Participants | Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version | Week 6 | 9.7 score on a scale | Standard Deviation 6.17 |
| All Participants | Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version | Week 8 | 9.6 score on a scale | Standard Deviation 7.02 |
| All Participants | Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version | Week 10 | 10.6 score on a scale | Standard Deviation 6.33 |
| All Participants | Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version | Week 12 | 10.6 score on a scale | Standard Deviation 7 |
Secondary
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.
Time frame: Baseline, 2, 4, 6, 8, 10, 12 week
Population: The number of participants analyzed at each time point varied because:~A caregiver was ineligible to participate due to their care recipient passing away.~A caregiver missed the tele-visit session on that particular week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8 | Baseline | 4.8 score on a scale | Standard Deviation 3.03 |
| All Participants | Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8 | Week 2 | 4.5 score on a scale | Standard Deviation 2.77 |
| All Participants | Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8 | Week 4 | 3.3 score on a scale | Standard Deviation 2.7 |
| All Participants | Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8 | Week 6 | 3.4 score on a scale | Standard Deviation 3.38 |
| All Participants | Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8 | Week 8 | 3.6 score on a scale | Standard Deviation 3.15 |
| All Participants | Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8 | Week 10 | 4.5 score on a scale | Standard Deviation 3.74 |
| All Participants | Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8 | Week 12 | 3.5 score on a scale | Standard Deviation 2.1 |
Secondary
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.
Time frame: Baseline, 2, 4, 6, 8, 10, 12 weeks
Population: The number of participants analyzed at each time point varied because:~A caregiver was ineligible to participate due to their care recipient passing away.~A caregiver missed the tele-visit session on that particular week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Caregiver Perception of Patient's Pain Score, as Measured by the Doloplus 2 Scale Behavioral Assessment | Baseline | 5.1 score on a scale | Standard Deviation 3.99 |
| All Participants | Mean Caregiver Perception of Patient's Pain Score, as Measured by the Doloplus 2 Scale Behavioral Assessment | Week 2 | 3.9 score on a scale | Standard Deviation 2.83 |
| All Participants | Mean Caregiver Perception of Patient's Pain Score, as Measured by the Doloplus 2 Scale Behavioral Assessment | Week 4 | 3.7 score on a scale | Standard Deviation 2.49 |
| All Participants | Mean Caregiver Perception of Patient's Pain Score, as Measured by the Doloplus 2 Scale Behavioral Assessment | Week 6 | 3.5 score on a scale | Standard Deviation 4.02 |
| All Participants | Mean Caregiver Perception of Patient's Pain Score, as Measured by the Doloplus 2 Scale Behavioral Assessment | Week 8 | 3.4 score on a scale | Standard Deviation 3.92 |
| All Participants | Mean Caregiver Perception of Patient's Pain Score, as Measured by the Doloplus 2 Scale Behavioral Assessment | Week 10 | 4.4 score on a scale | Standard Deviation 4.62 |
| All Participants | Mean Caregiver Perception of Patient's Pain Score, as Measured by the Doloplus 2 Scale Behavioral Assessment | Week 12 | 4.1 score on a scale | Standard Deviation 4.08 |