A Problem Solving Intervention for Post-ICU Cognitive Impairment in Older Adults (NCT03972384) | Clinical Trial Compass
CompletedNot Applicable
A Problem Solving Intervention for Post-ICU Cognitive Impairment in Older Adults
United States19 participantsStarted 2022-01-21
Plain-language summary
This study will apply an evidence based program to assist ICU survivors to overcome cognitive problems as a result of their critical illness. This study will determine feasibility of recruitment, retention and engagement with the program as well as acceptability of the program to the participants.
Who can participate
Age range
55 Years – 89 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:
* \>55 years old
* discharged home following an ICU stay,
* reside at home and were functionally independent prior to admission to the ICU based on family report,
* speak and read English,
* mechanically ventilated for at least 48 hours,
* have more than one positive clinical measurement of delirium during the ICU stay,
* Montreal Cognitive Assessment score (MoCA) between 25-17.
Exclusion Criteria:
* Pre-illness diagnosis of dementia or pre-morbid cognitive impairment (IQCODE score \>3.51);
* profound uncorrected visual or hearing impairment that precludes use of the telephone;
* psychiatric condition that precludes full participation in the intervention;
* substance abuse as measured by cut-off score of 2 on CAGE-Substance Abuse Screening Tool;
* discharge to hospice care.
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
Change of Cognitive function as measured by Self-Administered Gerocognitive Examination
Timeframe: Week 1 and week 12
2
Change in development of Chronic Illness self management practices(as measured by Self-Efficacy Scale)
Timeframe: Week 2 and Week 12
3
Change in medication adherence practices (as measured by Medication Management Instrument for Deficiencies in the Elderly (MedMaIDE))
Timeframe: Week 2 and Week 12
4
Change in participant's rate of depression as measured by Patient Health Questionnaire - 2)
Timeframe: Week 1 and Week 12
5
Change in anxiety levels as measured by Geriatric Anxiety Scale (GAS)
Timeframe: Week 1 and Week 12
6
Change in depression levels as measured by Geriatric Depression Scale (GDS)
Timeframe: Week 1 and Week 12
7
Change in Health related Quality of Life by a Short Form Health Survey - 36
Assess the effect of the Post-Intensive Care Problem Solving program through intervention completion rates
Timeframe: 15 months
9
Access change in participant use of the health system
Timeframe: Week 12
10
Assess change in functional independence when performing activities of daily living as measured by the Katz Activities of Daily Living Scale.
Timeframe: Week 1 and Week 12
11
Assess change in functional independence when performing instrumental activities of daily living using the Lawton Instrumental Activities of Daily Living.