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Behavioural Intervention
Virtual Reality + Cognitive Training for Mild Cognitive Impairment
N/A
Recruiting
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥ 55 years
Chronic HF Stage C validated from echocardiography or comparable measure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Awards & highlights
Study Summary
This trial aims to improve the health, quality of life, and survival of older adults with heart failure and cognitive impairment by testing a dual-component intervention.
Who is the study for?
This trial is for adults over 55 with heart failure (Stage C) and mild cognitive issues, like memory or concentration problems. They must speak English and have someone to report on their daily activities. It's not for those with advanced heart failure, significant vision/hearing issues, major neurological/psychiatric conditions, life-threatening illnesses besides heart failure, or recent cognitive training.Check my eligibility
What is being tested?
The study tests a two-part treatment combining virtual reality-based cognitive restoration and computerized brain exercises to improve thinking skills and overall health in older adults with both heart failure and mild cognitive impairment.See study design
What are the potential side effects?
Since the interventions involve virtual reality experiences and computerized tasks designed to stimulate the brain, side effects might include discomfort from wearing VR headsets such as eye strain or dizziness but are generally expected to be minimal.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 55 years old or older.
Select...
My heart failure is at Stage C, confirmed by an echo test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Body Weight Changes
Cognition
Secondary outcome measures
Changes in health-related quality of life
Heart failure
Changes in instrumental activities of daily living
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Vita+Com (Both Vita and Com intervention)Experimental Treatment1 Intervention
Participants randomized to Vita+Com will receive both Vita and Com simultaneously. They will spend 10 minutes on Vita and then 1 hour on Com per day, 2-3 days/week for 8 weeks (a total of 23.3 hours). Participants will receive weekly check-in calls from the intervention RA during the 8 weeks of intervention phase.
Group II: Vita (virtual reality-based cognitive restoration intervention)Experimental Treatment1 Intervention
Participants randomized to Vita will receive a virtual reality head-mount device (e.g., Oculus Quest) to view nature pictures for 10 minutes (1 set of 10 pictures)/day, 2-3 days/week for 8 weeks (a total of 20 sets for 200 minutes, approximately 3.3 hours) based on the provided activity schedule. Participants will receive weekly check-in calls from the intervention RA during the 8 weeks of intervention phase.
Group III: Com (computerized cognitive training intervention )Experimental Treatment1 Intervention
Participants randomized to Com will receive a tablet computer (e.g., iPad) to complete BrainHQ training for 1 hour (6 exercises)/day, 2-3 days/week for 8 weeks (total of 20 hours) based on the provided activity schedule. Participants will receive weekly check-in calls from the intervention RA during the 8 weeks of intervention phase.
Group IV: Usual careActive Control1 Intervention
Participants randomized to this control condition will continue to receive their usual care, but no interventions from the study team. We will monitor changes in their activities that may affect changes in cognitive function (e.g., starting book clubs) by weekly check-in calls during the 8 weeks of intervention phase.
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
981,590 Total Patients Enrolled
17 Trials studying Heart Failure
3,627 Patients Enrolled for Heart Failure
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,713 Total Patients Enrolled
42 Trials studying Heart Failure
213,143 Patients Enrolled for Heart Failure
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not used computerized brain training or been in brain training studies this past year.I am 55 years old or older.I do not have a major neurological disorder like dementia or Parkinson's.You have a serious mental illness like schizophrenia or bipolar disorder.I do not have a life-threatening illness other than heart failure.I have someone who can provide details about my daily activities.I can make my own medical decisions or have someone who can.My heart failure is either at an early stage or very advanced.You have vision or hearing problems that could make it difficult for you to complete cognitive tests.My heart failure is at Stage C, confirmed by an echo test.
Research Study Groups:
This trial has the following groups:- Group 1: Vita (virtual reality-based cognitive restoration intervention)
- Group 2: Com (computerized cognitive training intervention )
- Group 3: Vita+Com (Both Vita and Com intervention)
- Group 4: Usual care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there current vacancies for participating in this trial?
"Affirmative. According to information hosted on clinicaltrials.gov, this medical trial is still actively recruiting patients since its original post date of April 3rd 2023 and last edit on April 6th 2023. 172 volunteers are currently being sought from one site."
Answered by AI
How many individuals have enrolled in the trial to date?
"Yes, this is accurate. According to clinicaltrials.gov's records, the study was initially published on April 3rd 2023 and has most recently been updated on April 6th 2023. It requires 172 patients at a single centre for full enrollment."
Answered by AI
What aims are being sought out by this research?
"This medical trial will assess changes in memory, instrumental activities of daily living, dementia-free survival rates, and heart failure self-care over four time frames: baseline (start), 8 weeks later, 16 weeks after that, and 1 year post the initial measurement. The outcomes are quantified using the Everyday Problems Test for patients alone, patient survival statuses from electronic health records at Year one mark, and a Self-Care of Heart Failure Index."
Answered by AI
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