Harmony at Home: A Pilot Telehealth Program for Rural ADRD Caregivers (NCT05202223) | Clinical Trial Compass
CompletedNot Applicable
Harmony at Home: A Pilot Telehealth Program for Rural ADRD Caregivers
United States80 participantsStarted 2022-01-15
Plain-language summary
There is a need for caregiver-initiated and -implemented non-pharmacological interventions directly to and for the person with dementia, including environmental assessment and modification, as first-line treatments for behavioral and psychological symptoms of dementia (BPSD) in persons living with dementia (PLWD). Delivered via telehealth, Harmony at HOME (H@H) aims to train caregivers of persons with moderate to severe ADRD in the skills of assessing and modifying the home environment to promote "person-environment fit," a concept that posits that the ability to access features within a built environment (e.g. bathroom, stairs,) or that factors within the environment itself (lighting, noise level, temperature), especially when linked with individualized social support, contribute to or even shape behavior.
In addition to the intervention, the first 10 caregiver participants to enroll will also be invited to participate in two focus groups that will be facilitated during and after the intervention. The first focus group focuses on experiences as a dementia caregiver in rural areas. The second focus group focuses on providing feedback regarding caregivers' perceptions, acceptability, and usefulness of the H@H intervention. These focus groups will be conducted as structured interviews with open-ended questions that encourage participants to share their experiences.
Who can participate
Age range
21 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Men or women aged 21-99, inclusive.
. Willingness and ability to participate in trial and implement recommended intervention strategies throughout the duration of the study.
. Access to and ability to use video technology (Zoom) for telehealth visits.
. English speaking, able to read and write.
. Ability to retrieve and return mail.
. Men or women aged 65-99, inclusive.
. Living at home in the community with one primary caregiver.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 3\. Diagnosis of Alzheimer's disease as primary dementia type of moderate to severe stages (confirmed by Clinical Dementia Rating Scale score of 1.0+)
Exclusion criteria
. Diagnosis of mild cognitive impairment or dementia.
. Severe psychological stress or active state of psychiatric conditions (severe depression, mania, hallucinations/delusions).
. Unstable medical conditions within one month prior to screening visit such as poorly controlled blood pressure, diabetes, current cancer diagnosis, or breathing problems, etc.
. Wheelchair or bed bound.
. Residence in skilled nursing facility or facility-based care.
. Skin lesions or skin abnormalities throughout upper extremities.
. Allergies related to lotion or fragrance.
. Caregiver report of physically violent behaviors.