Heart FailureNCT05601817
Virtual Reality and Computerized Cognitive Intervention for Mild Cognitive Impairment in Heart Failure
A study testing Vita, Com and Vita+Com in people with Heart Failure and Mild Cognitive Impairment, run by Indiana University at 1 site in United States.
Trial summary
This research project is relevant to public health because both heart failure (HF) and mild cognitive impairment (e.g., trouble remembering and concentrating beyond normal aging) are highly prevalent among older adults in the United States. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Heart Failure, Mild Cognitive Impairment
- What is being tested?
- Vita, Com and Vita+Com
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2023to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 55 years;
- chronic HF Stage C validated from echocardiography or comparable measure or B-type natriuretic peptide (BNP) level > 400 pg/ml [or equivalent NT-proBNP] in past 3 years;
- ability to communicate in English;
- capacity to consent according to the Indiana University Institutional Review Board policies, or lacks capacity to consent but has the ability to provide assent from someone who can serve as LAR; and
- Subjectively reported cognitive concern assessed by the question, "Do you have any trouble with your memory or thinking?".
Who cannot join
- pre-HF (Stages A and B) or advanced HF (Stage D);
- vision or hearing problems that can interfere with cognitive testing;
- major neurological disorder (e.g., previously diagnosed dementia, Parkinson's disease, epilepsy, multiple sclerosis);
- major psychiatric disease (e.g., schizophrenia, bipolar disorder);
- life-threatening unstable illness other than HF (e.g., end-stage cancer); and
- users of regular computerized cognitive training or participants in cognitive training trials in the past year.
- Second, we will enroll patients only if they have MCI or normal cognition by not meeting criteria for dementia.
Trial locations and contacts
1 site in 1 country.
About this study
This research project is relevant to public health because both heart failure (HF) and mild cognitive impairment (e.g., trouble remembering and concentrating beyond normal aging) are highly prevalent among older adults in the United States. Despite advances in health care, there are no effective interventions for treating cognitive impairment in HF, which if left untreated, leads to suboptimal health, quality of life, and shorter survival. Therefore, the investigators propose to test the effect of a dual-component intervention comprised of a virtual reality-based cognitive restoration intervention and computerized cognitive training on cognitive function and overall health among 172 older adults with HF who experience mild cognitive impairment.
Read the detailed description
Heart failure (HF) and mild cognitive impairment (MCI) are prevalent among older adults in the U.S. Patients with HF are twice as likely to have MCI than people without HF. Cognitive impairment in HF is associated with significant decline in one's ability to take care of one's self and higher 12-month mortality. A small number of cognitive interventions have demonstrated preliminary efficacy in improving cognitive function in HF. However, this work suffers from some major limitations: 1) lack of focus on patients who already have cognitive impairments and at higher risk of dementia; 2) focus on single-component interventions; 3) lack of evaluation of responsiveness variables including genetic biomarkers; and 4) lack of long-term follow-up. Dr. Miyeon Jung, PhD, RN proposes to address this gap by conducting a randomized controlled pilot trial to estimate the preliminary efficacy of a virtual reality-based cognitive restoration (Vita) combined with a computerized cognitive training intervention (Com) relative to each intervention alone and standard of care among 172 older HF patients with MCI. The Specific aims of the project are to estimate the effects of the Vita and Com interventions individually and in combination to improve: 1) attention and memory (Aim 1); 2) HF self-care, instrumental activities of daily living, and health-related quality of life (Aim 2); and 3) dementia free survival (Aim 3) over 1 year. An exploratory aim is to examine moderating factors that may influence intervention efficacy (i.e., baseline cognitive function, depressive symptoms, HF severity, and presence of apolipoprotein E ε4 and BDNF Met allele).
- Conditions
- Heart Failure, Mild Cognitive Impairment
- Being tested
- Vita, Com, Vita+Com
- Keywords
- heart failure, mild cognitive impairment, older adults, cognitive intervention, cognitive training, attention restoration, virtual reality
- Medical subject headings
- Heart Failure, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitaBehavioural
Vita is developed by this study team based on Attention Restoration Theory. The Vita intervention involves viewing 360 degree nature pictures on a virtual reality headset.
ComBehavioural
Com intervention uses BrainHQ from PositScience that was developed based on the brain neuroplasticity. The com intervention involves doing game-like training on a iPad.
Vita+ComBehavioural
Vita+Com intervention is a combination of both Vita and Com interventions. Participants will be asked to complete Vita first and then Com intervention.
| Study group | Role | What they receive |
|---|---|---|
| Vita (virtual reality-based cognitive restoration intervention) | Experimental | 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. Receives: Behavioral: Vita |
| Com (computerized cognitive training intervention ) | Experimental | 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. Receives: Behavioral: Com |
| Vita+Com (Both Vita and Com intervention) | Experimental | 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. Receives: Behavioral: Vita+Com |
| Usual care | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cognitive function: attention
Trail Making and Number Span Test from National Alzheimer's Coordinating Center Neuropsychological battery (Uniform Data Set V3.0)
Measured: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Changes in cognitive function: memory
Craft Story 21 and Benson Figure Copy for memory from National Alzheimer's Coordinating Center Neuropsychological battery (Uniform Data Set V3.0)
Measured: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Secondary outcomes (5)
Changes in heart failure self-care
Self-Care of Heart Failure Index
Measured: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Changes in instrumental activities of daily living
Functional Activities Questionnaire (for both patients and informants)
Measured: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Changes in instrumental activities of daily living
Everyday Problems Test (performance-based, for patient only)
Measured: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Changes in health-related quality of life
Minnesota Living with Heart Failure Questionnaire
Measured: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Dementia-free survival
Survival status (alive or deceased) at year collected from electronic health records
Measured: 1 year after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start3 Apr 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- A 2 by 2 factorial design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Miyeon Jung, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601817
- Sponsor's protocol ID
- 15739
- Other IDs
- 1K76AG074940-01A1
- Status last verified
- Mar 2026
- First submitted
- 24 Oct 2022
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality and Computerized Cognitive Intervention for Mild Cognitive Impairment in Heart Failure
- ClinicalTrials.gov ID
- NCT05601817
- Acronym / sponsor ID
- 15739
- Conditions
- Heart Failure, Mild Cognitive Impairment
- Keywords
- heart failure, mild cognitive impairment, older adults, cognitive intervention, cognitive training, attention restoration, virtual reality
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research project is relevant to public health because both heart failure (HF) and mild cognitive impairment (e.g., trouble remembering and concentrating beyond normal aging) are highly prevalent among older adults in the United States. Despite advances in health care, there are no effective interventions for treating cognitive impairment in HF, which if left untreated, leads to suboptimal health, quality of life, and shorter survival. Therefore, the investigators propose to test the effect of a dual-component intervention comprised of a virtual reality-based cognitive restoration intervention and computerized cognitive training on cognitive function and overall health among 172 older adults with HF who experience mild cognitive impairment.
Detailed description
Heart failure (HF) and mild cognitive impairment (MCI) are prevalent among older adults in the U.S. Patients with HF are twice as likely to have MCI than people without HF. Cognitive impairment in HF is associated with significant decline in one's ability to take care of one's self and higher 12-month mortality. A small number of cognitive interventions have demonstrated preliminary efficacy in improving cognitive function in HF. However, this work suffers from some major limitations: 1) lack of focus on patients who already have cognitive impairments and at higher risk of dementia; 2) focus on single-component interventions; 3) lack of evaluation of responsiveness variables including genetic biomarkers; and 4) lack of long-term follow-up. Dr. Miyeon Jung, PhD, RN proposes to address this gap by conducting a randomized controlled pilot trial to estimate the preliminary efficacy of a virtual reality-based cognitive restoration (Vita) combined with a computerized cognitive training intervention (Com) relative to each intervention alone and standard of care among 172 older HF patients with MCI. The Specific aims of the project are to estimate the effects of the Vita and Com interventions individually and in combination to improve: 1) attention and memory (Aim 1); 2) HF self-care, instrumental activities of daily living, and health-related quality of life (Aim 2); and 3) dementia free survival (Aim 3) over 1 year. An exploratory aim is to examine moderating factors that may influence intervention efficacy (i.e., baseline cognitive function, depressive symptoms, HF severity, and presence of apolipoprotein E ε4 and BDNF Met allele).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A 2 by 2 factorial design
| Arm | Type | Receives |
|---|---|---|
| Vita (virtual reality-based cognitive restoration intervention) | Experimental | Behavioral: VitaParticipants 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. |
| Com (computerized cognitive training intervention ) | Experimental | Behavioral: ComParticipants 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. |
| Vita+Com (Both Vita and Com intervention) | Experimental | Behavioral: Vita+ComParticipants 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. |
| Usual care | No 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 55 years;
- chronic HF Stage C validated from echocardiography or comparable measure or B-type natriuretic peptide (BNP) level > 400 pg/ml [or equivalent NT-proBNP] in past 3 years;
- ability to communicate in English;
- capacity to consent according to the Indiana University Institutional Review Board policies, or lacks capacity to consent but has the ability to provide assent from someone who can serve as LAR; and
- Subjectively reported cognitive concern assessed by the question, "Do you have any trouble with your memory or thinking?".
Key exclusion criteria (7 listed)
- pre-HF (Stages A and B) or advanced HF (Stage D);
- vision or hearing problems that can interfere with cognitive testing;
- major neurological disorder (e.g., previously diagnosed dementia, Parkinson's disease, epilepsy, multiple sclerosis);
- major psychiatric disease (e.g., schizophrenia, bipolar disorder);
- life-threatening unstable illness other than HF (e.g., end-stage cancer); and
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitaVita is developed by this study team based on Attention Restoration Theory. The Vita intervention involves viewing 360 degree nature pictures on a virtual reality headset. | Behavioural | Vita (virtual reality-based cognitive restoration intervention) |
| ComCom intervention uses BrainHQ from PositScience that was developed based on the brain neuroplasticity. The com intervention involves doing game-like training on a iPad. | Behavioural | Com (computerized cognitive training intervention ) |
| Vita+ComVita+Com intervention is a combination of both Vita and Com interventions. Participants will be asked to complete Vita first and then Com intervention. | Behavioural | Vita+Com (Both Vita and Com intervention) |
Primary outcome
Changes in cognitive function: attention
Time frame: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Trail Making and Number Span Test from National Alzheimer's Coordinating Center Neuropsychological battery (Uniform Data Set V3.0)
Changes in cognitive function: memory
Time frame: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Craft Story 21 and Benson Figure Copy for memory from National Alzheimer's Coordinating Center Neuropsychological battery (Uniform Data Set V3.0)
5 secondary outcomes
Changes in heart failure self-care
Time frame: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Changes in instrumental activities of daily living
Time frame: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Changes in instrumental activities of daily living
Time frame: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Changes in health-related quality of life
Time frame: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Dementia-free survival
Time frame: 1 year after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Failure
Active, not recruiting
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
Heart Failure, Congestive Heart Failure
Active, not recruiting
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction, Concentric Hypertrophy
Recruiting
Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
HFrEF - Heart Failure With Reduced Ejection Fraction
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vita, Com and Vita+Com in people with Heart Failure and Mild Cognitive Impairment, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cognitive function: attention (time frame: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026; AzTrials last refreshed its copy on 29 Oct 2026.