mHealth Mindfulness With Patients With Serious Illness and Their Caregivers (NCT05040711) | Clinical Trial Compass
RecruitingNot Applicable
mHealth Mindfulness With Patients With Serious Illness and Their Caregivers
United States162 participantsStarted 2022-04-26
Plain-language summary
Older adults with serious illness and their caregivers have high rates of anxiety and limited access to effective, non-pharmacological treatments. A recent National Academy of Medicine report recommended increased emphasis on disseminating and implementing evidence-based psychotherapies in order to have maximal public health impact. Through this work, I will identify a sustainable and potentially scalable dyadic intervention and delivery model to manage symptoms of anxiety in older adults with serious illness and their caregivers in primary care.
Who can participate
Age range
21 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:
* adults 60+
* Diagnosis of or caregiver for individual with serious illnesses (e.g., ESRD, Cancer, CHF, COPD, Liver Disease)
* Hads-A \> 8 for patient or caregiver
* Blessed\<6
* fluent in English
* vision and hearing does not interfere with mobile device use
* caregivers who must be 21+
* caregiver must identify as primary source of informal care for patient
* Caregiver blessed \<6
* caregiver is fluent in English
* Caregiver's vision and hearing does not interfere with mobile device use.
Exclusion Criteria:
* experience with mindfulness therapy in last 2 years
* not fluent in English
* vision or hearing that impairs use of mobile device
* cognitive impairment more than 6 on Blessed.
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
Hospital Anxiety and Depression Scale - Anxiety Sub Scale
Timeframe: 6 months
2
Hospital Anxiety and Depression Scale - Anxiety Sub Scale
Timeframe: 8 weeks
Trial details
NCT IDNCT05040711
SponsorRutgers, The State University of New Jersey