Pilot Feasibility Trial of HEALthy Beginnings for Middle-Aged, and Older Homeless Women (NCT06743685) | Clinical Trial Compass
CompletedNot Applicable
Pilot Feasibility Trial of HEALthy Beginnings for Middle-Aged, and Older Homeless Women
United States23 participantsStarted 2025-03-03
Plain-language summary
This is a mixed methods pilot feasibility trial of HEALthy Beginnings, an innovative, nurse-driven intervention. Middle-aged and older, homeless women (MAO-HW) will participate in the HEALthy Beginnings intervention and select MAO-HW will be invited to participate in post-intervention qualitative focus groups to evaluate the program.
Who can participate
Age range
40 Years
Sex
FEMALE
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:
* Self-reported age 40 years or older
* Sex assigned Female at birth
* Homeless, or living in a shelter designed to provide transitional housing
* Self-reported multimorbidity (at least 2 physical/mental health conditions)
* Able to communicate in English
Exclusion Criteria:
* Experiencing hallucinations
* Exhibiting signs of acute intoxication (e.g., slurred speech, pin-point pupils, difficulty walking)
* Non-English speaking
* Unable to understand study procedures (e.g., screening questions)
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
Recruitment as a measure of feasibility of the HEALthy Beginnings intervention
Timeframe: Day 1
2
Completion as a measure of feasibility of the HEALthy Beginnings intervention
Timeframe: Upon completion of all group and individual sessions, approximately 12 Weeks