Feasibility and Efficacy of PRO-MAMAS (NCT06895629) | Clinical Trial Compass
CompletedNot Applicable
Feasibility and Efficacy of PRO-MAMAS
Israel14 participantsStarted 2025-03-30
Plain-language summary
This experimental design will assess the feasibility \& initial effectiveness of PRO-MAMAS (promoting participation, health and wellbeing through meaningful maternal-role activities after stroke and other chronic conditions) - a novel occupational therapy intervention program to promote participation, health and wellbeing of older mothers with chronic stroke.
Assessments will be conducted at three time points: baseline, pre, post the Pro-MAMA intervention
Who can participate
Age range
70 Years – 100 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:
* Women
* Aged 70 and older
* Mothers (have at least one live and healthy child)
* With chronic stroke (at lease six months from stroke onset) or other age-related chronic conditions
* That live at home
* That they can walk independently (with or without a walking aid)
* Without significant cognitive decline (MoCA ≥19)
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
Satisfaction with PRO-MAMAS intervention
Timeframe: Post intervention (week 8)
2
Change in scores of the Canadian Occupational Performance Measure (COPM)
Timeframe: Change from pre (week 3) to post intervention (week 8)
3
Change in scores of the Short Form Health Survey (SF-12)
Timeframe: Change from pre (week 3) to post intervention (week 8)
4
Change in scores of the Satisfaction with Life Scale (SWLS)
Timeframe: Change from pre (week 3) to post intervention (week 8)