Trial Outcomes & Findings for Harmony at Home: A Pilot Telehealth Program for Rural ADRD Caregivers (NCT NCT05202223)
NCT ID: NCT05202223
Last Updated: 2023-12-29
Results Overview
Pearlin Mastery Scale: A 4-item scale measuring the extent to which a participant sees life as being under his/her personal control vs. something that is fatalistically ruled. Scores range from 4 to 16, with higher scores indicating greater levels of mastery.
COMPLETED
NA
80 participants
baseline, visit 2 (week 6), visit 3 (week 10)
2023-12-29
Participant Flow
Participant milestones
| Measure |
Harmony at HOME
H@H is a 6-week telehealth intervention delivered by an occupational therapist during weekly visits.
Harmony at HOME (H@H): H@H is a 6-week telehealth intervention delivered by an occupational therapist during weekly visits.
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|---|---|
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Overall Study
STARTED
|
80
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Overall Study
COMPLETED
|
52
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Overall Study
NOT COMPLETED
|
28
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only 78 participants completed baseline data collection
Baseline characteristics by cohort
| Measure |
Harmony at HOME
n=78 Participants
H@H is a 6-week telehealth intervention delivered by an occupational therapist during weekly visits.
Harmony at HOME (H@H): H@H is a 6-week telehealth intervention delivered by an occupational therapist during weekly visits.
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|---|---|
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Age, Continuous
Caregiver
|
60.69 years
STANDARD_DEVIATION 1.99 • n=39 Participants • Only 78 participants completed baseline data collection
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Age, Continuous
Participant with Dementia
|
78.74 years
STANDARD_DEVIATION 1.09 • n=39 Participants • Only 78 participants completed baseline data collection
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Sex: Female, Male
Caregiver · Female
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6 Participants
n=39 Participants • There was no response to this question for 8 participants
|
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Sex: Female, Male
Caregiver · Male
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33 Participants
n=39 Participants • There was no response to this question for 8 participants
|
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Sex: Female, Male
Participant with Dementia · Female
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11 Participants
n=31 Participants • There was no response to this question for 8 participants
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Sex: Female, Male
Participant with Dementia · Male
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20 Participants
n=31 Participants • There was no response to this question for 8 participants
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Ethnicity (NIH/OMB)
Caregiver · Hispanic or Latino
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0 Participants
n=39 Participants • 78 completed baseline data collection
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Ethnicity (NIH/OMB)
Caregiver · Not Hispanic or Latino
|
37 Participants
n=39 Participants • 78 completed baseline data collection
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|
Ethnicity (NIH/OMB)
Caregiver · Unknown or Not Reported
|
2 Participants
n=39 Participants • 78 completed baseline data collection
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Ethnicity (NIH/OMB)
Participant with Dementia · Hispanic or Latino
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0 Participants
n=39 Participants • 78 completed baseline data collection
|
|
Ethnicity (NIH/OMB)
Participant with Dementia · Not Hispanic or Latino
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29 Participants
n=39 Participants • 78 completed baseline data collection
|
|
Ethnicity (NIH/OMB)
Participant with Dementia · Unknown or Not Reported
|
10 Participants
n=39 Participants • 78 completed baseline data collection
|
|
Race (NIH/OMB)
Caregiver · American Indian or Alaska Native
|
0 Participants
n=39 Participants • 78 participants completed baseline data collection.
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|
Race (NIH/OMB)
Caregiver · Asian
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0 Participants
n=39 Participants • 78 participants completed baseline data collection.
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|
Race (NIH/OMB)
Caregiver · Native Hawaiian or Other Pacific Islander
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0 Participants
n=39 Participants • 78 participants completed baseline data collection.
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|
Race (NIH/OMB)
Caregiver · Black or African American
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1 Participants
n=39 Participants • 78 participants completed baseline data collection.
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|
Race (NIH/OMB)
Caregiver · White
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35 Participants
n=39 Participants • 78 participants completed baseline data collection.
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|
Race (NIH/OMB)
Caregiver · More than one race
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0 Participants
n=39 Participants • 78 participants completed baseline data collection.
|
|
Race (NIH/OMB)
Caregiver · Unknown or Not Reported
|
3 Participants
n=39 Participants • 78 participants completed baseline data collection.
|
|
Race (NIH/OMB)
Participant with Dementia · American Indian or Alaska Native
|
0 Participants
n=39 Participants • 78 participants completed baseline data collection.
|
|
Race (NIH/OMB)
Participant with Dementia · Asian
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0 Participants
n=39 Participants • 78 participants completed baseline data collection.
|
|
Race (NIH/OMB)
Participant with Dementia · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants • 78 participants completed baseline data collection.
|
|
Race (NIH/OMB)
Participant with Dementia · Black or African American
|
1 Participants
n=39 Participants • 78 participants completed baseline data collection.
|
|
Race (NIH/OMB)
Participant with Dementia · White
|
30 Participants
n=39 Participants • 78 participants completed baseline data collection.
|
|
Race (NIH/OMB)
Participant with Dementia · More than one race
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0 Participants
n=39 Participants • 78 participants completed baseline data collection.
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|
Race (NIH/OMB)
Participant with Dementia · Unknown or Not Reported
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8 Participants
n=39 Participants • 78 participants completed baseline data collection.
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Region of Enrollment
United States
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80 participants
n=78 Participants
|
PRIMARY outcome
Timeframe: baseline, visit 2 (week 6), visit 3 (week 10)Population: Only caregiver data are reported for this outcome. 1 participant was unable to be contacted for visit 3 data collection
Pearlin Mastery Scale: A 4-item scale measuring the extent to which a participant sees life as being under his/her personal control vs. something that is fatalistically ruled. Scores range from 4 to 16, with higher scores indicating greater levels of mastery.
Outcome measures
| Measure |
Harmony at HOME
n=26 Participants
H@H is a 6-week telehealth intervention delivered by an occupational therapist during weekly visits.
Harmony at HOME (H@H): H@H is a 6-week telehealth intervention delivered by an occupational therapist during weekly visits.
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|---|---|
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Change in Caregiver Mastery
Baseline
|
12.6 units on a scale
Standard Deviation 2.1
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Change in Caregiver Mastery
Visit 2
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13 units on a scale
Standard Deviation 1.6
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Change in Caregiver Mastery
Visit 3
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13 units on a scale
Standard Deviation 1.7
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OTHER_PRE_SPECIFIED outcome
Timeframe: Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up)]Zarit Burden Interview: It is a questionnaire consisting of 22 items. A minimum score of 0 and a maximum score of 88 can be obtained. The higher the scale score, the higher the difficulty experienced.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up)]Perceived Stress Scale: Caregiver report of perceived stress. The minimum total score possible is 0 and the maximum total score possible is 40. Higher values represent a worse outcome.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up)Revised Caregiving Appraisal Scale, Sub-scale on caregiver satisfaction: Care partner satisfaction consisting of 6-items, 5-point Likert scale. Higher score indicates greater satisfaction.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up)Revised Memory and Behavior Problems Checklist: 24-item caregiver report measure, 5-point Likert scale, higher scores mean greater behavioral problems.
Outcome measures
Outcome data not reported
Adverse Events
Harmony at HOME
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Harmony at HOME
n=40 participants at risk
This is a single-arm study. Dyads (caregiver and person with dementia) were enrolled in the H@H telehealth intervention delivered by an occupational therapist during weekly visits.
Participants were either 1) caregiver or 2) person with dementia (person at risk). Adverse Events are reported for persons with dementia.
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|---|---|
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General disorders
Fall
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30.0%
12/40 • 10 weeks
All-Cause Mortality, Serious Adverse Events and Other Adverse Events were reported for participants with dementia. All-Cause Mortality, Serious Adverse Events and Other Adverse Events were not monitored/assessed in caregiver participants.
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General disorders
Hospitalization
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5.0%
2/40 • 10 weeks
All-Cause Mortality, Serious Adverse Events and Other Adverse Events were reported for participants with dementia. All-Cause Mortality, Serious Adverse Events and Other Adverse Events were not monitored/assessed in caregiver participants.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place