Using Technology to Support Care Partners for Persons With Alzheimer's Disease: Tele-STELLA (NCT04627662) | Clinical Trial Compass
CompletedNot Applicable
Using Technology to Support Care Partners for Persons With Alzheimer's Disease: Tele-STELLA
United States375 participantsStarted 2021-05-14
Plain-language summary
The purpose of this study is to test a revised psychoeducational intervention to help Care Partners for family members with dementia understand and reduce the distressing behaviors that come with progressive dementia. Tele-STELLA (Support via TEchnology: Living and Learning with Advancing Alzheimer's disease and related dementias) is a multicomponent videoconference-based intervention designed to facilitate effective management of behavioral and psychological symptoms common to the later stages of dementia. In the Tele-STELLA intervention, professionals ("Guides") meet with family members ("Care Partners") who care for persons with dementia. Working together, the Care Partners and Guides identify strategies to address upsetting behaviors. The goal of this intervention is to reduce upsetting behaviors and, thus, Care Partner burden.
Who can participate
Age range
18 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.
Care Recipient Inclusion Criteria:
* Diagnosis of ADRD, moderate to late stages as defined by family member (Box 1)
* Exhibits 2 or more behaviors listed on RMBPC that are bothersome to the Care Partner and occur 3 or more times/week at study enrollment
* Family member of Care Partner (this can be a relative, spouse or close kin that is considered family)
Care Recipient Exclusion Criteria:
* Dementia not related to ADRD
* Unable to leave Care Partner during Tele-STELLA sessions
* Early stage dementia, as defined by family member
Care Partner Inclusion Criteria:
* Adult caring for family member with ADRD
* Provides care for at least 4 hours/week
* Age of 18 years or older
* Speaks and understands English to be able to participate in intervention
* Owns a telephone (smartphone, cell phone or landline)
* Has mailing address to receive computer and study materials
* Provides informed consent to participate in the Research
Care Partner Exclusion Criteria:
* Unable to find activity for care recipient during Tele-STELLA sessions to allow Care Partner to work privately with Guide and other Care Partners.
* Completed similar telehealth intervention within the last year
* Hearing and/or vision problems severe enough to prevent participation
* Unwilling or unable to adequately follow study instructions and participate in study procedures
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.
What they're measuring
1
Revised Memory and Behavior Problems Checklist, Reactivity Subscale
Timeframe: Baseline (1 week pre-Nova); post-Nova (8 weeks); 1-month follow-up (12 weeks). For Constellation: baseline (1 week pre-start); post (8 weeks); 2-month follow-up (16 weeks). Constellation could begin up to 12 months after Nova.
2
Revised Memory and Behavior Problems Checklist, Frequency Subscale
Timeframe: Baseline (1 week pre-Nova); post-Nova (8 weeks); 1-month follow-up (12 weeks). For Constellation: baseline (1 week pre-start); post (8 weeks); 2-month follow-up (16 weeks). Constellation could begin up to 12 months after Nova.