Active — Not RecruitingNot Applicable

Supportive Care for Cognitively Impaired Patients and Families

United States200 participantsStarted 2019-12-18

Plain-language summary

Currently almost 5 million Americans suffer from the distressing symptoms related to dementia and this number that will triple by 2050. The overall goals of the proposed project are to evaluate, in community dwelling Alzheimer's Disease Research Center participants the benefits of a 12-month nurse-led early palliative intervention on symptoms, quality of life, health care resource use. The relevance of this research to public health is that there is an urgent need to improve the palliative care of persons with dementia living in the community. This study will contribute substantially to that effort.

Who can participate

Age range

65 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.

Exclusion criteria

. Institutionalized (not a community dweller) at the time of entry into the study;
. Have severe dementia and are incapable of responding to the outcome measures at baseline. 3. Participants who live alone and don't have a proxy will be excluded only if they are deemed as lacking the capacity to provide informed consent at the time of entry into the study.

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

To identify the number of participants who express supportive care needs in both arms.

Timeframe: Day 0, 4 months, one year

Change in Zarit Caregiver Burden scores over time:

Timeframe: Day 0, 4 months, one year, 18 months

Completion of goals of care discussion and documentation of advance directives (AD) and the Physicians Orders for Life Sustaining Treatment (POLST) in the electronic health records.

Timeframe: Day 0, 4 months, one year, 18 months

Trial details

NCT IDNCT03881579

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-30

View on ClinicalTrials.gov More Dementia trials

Plain-language summary

Who can participate

Age range

65 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.

Exclusion criteria

. Institutionalized (not a community dweller) at the time of entry into the study;
. Have severe dementia and are incapable of responding to the outcome measures at baseline. 3. Participants who live alone and don't have a proxy will be excluded only if they are deemed as lacking the capacity to provide informed consent at the time of entry into the study.

What they're measuring

To identify the number of participants who express supportive care needs in both arms.

Timeframe: Day 0, 4 months, one year

Change in Zarit Caregiver Burden scores over time:

Timeframe: Day 0, 4 months, one year, 18 months

Completion of goals of care discussion and documentation of advance directives (AD) and the Physicians Orders for Life Sustaining Treatment (POLST) in the electronic health records.

Timeframe: Day 0, 4 months, one year, 18 months