search
Back to results

Virtual Reality and Computerized Cognitive Intervention for Mild Cognitive Impairment in Heart Failure

Primary Purpose

Heart Failure, Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vita
Com
Vita+Com
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring heart failure, mild cognitive impairment, older adults, cognitive intervention, cognitive training, attention restoration, virtual reality

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

We will use a two-step process to screen and enroll the patients. First, we will screen potentially eligible patients from the Indiana University Health systems using these eligibility criteria. Inclusion Criteria: ≥ 55 years; chronic HF Stage C validated from echocardiography or comparable measure; ability to communicate in English; a someone (e.g., family member, significant other, close friend) who agrees to serve as an informant and provide information of the patient's IADL; and 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. Exclusion Criteria: 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 by: 1) having MoCA score 23 and lower; and 2) not meeting criteria for dementia.

Sites / Locations

  • Indiana UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Vita (virtual reality-based cognitive restoration intervention)

Com (computerized cognitive training intervention )

Vita+Com (Both Vita and Com intervention)

Usual care

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Changes in cognitive function: attention
Trail Making and Number Span Test from National Alzheimer's Coordinating Center Neuropsychological battery (Uniform Data Set V3.0)
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)

Secondary Outcome Measures

Changes in heart failure self-care
Self-Care of Heart Failure Index
Changes in instrumental activities of daily living
Functional Activities Questionnaire (for both patients and informants)
Changes in instrumental activities of daily living
Everyday Problems Test (performance-based, for patient only)
Changes in health-related quality of life
Minnesota Living with Heart Failure Questionnaire
Dementia-free survival
Survival status (alive or deceased) at year collected from electronic health records

Full Information

First Posted
October 24, 2022
Last Updated
October 20, 2023
Sponsor
Indiana University
Collaborators
National Institute on Aging (NIA)
search

1. Study Identification

Unique Protocol Identification Number
NCT05601817
Brief Title
Virtual Reality and Computerized Cognitive Intervention for Mild Cognitive Impairment in Heart Failure
Official Title
Virtual Reality and Computerized Cognitive Intervention for Mild Cognitive Impairment in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Mild Cognitive Impairment
Keywords
heart failure, mild cognitive impairment, older adults, cognitive intervention, cognitive training, attention restoration, virtual reality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
A 2 by 2 factorial design
Masking
InvestigatorOutcomes Assessor
Masking Description
Single-blind
Allocation
Randomized
Enrollment
172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vita (virtual reality-based cognitive restoration intervention)
Arm Type
Experimental
Arm Description
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.
Arm Title
Com (computerized cognitive training intervention )
Arm Type
Experimental
Arm Description
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.
Arm Title
Vita+Com (Both Vita and Com intervention)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Vita
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Com
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Vita+Com
Intervention Description
Vita+Com intervention is a combination of both Vita and Com interventions. Participants will be asked to complete Vita first and then Com intervention.
Primary Outcome Measure Information:
Title
Changes in cognitive function: attention
Description
Trail Making and Number Span Test from National Alzheimer's Coordinating Center Neuropsychological battery (Uniform Data Set V3.0)
Time Frame
Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Title
Changes in cognitive function: memory
Description
Craft Story 21 and Benson Figure Copy for memory from National Alzheimer's Coordinating Center Neuropsychological battery (Uniform Data Set V3.0)
Time Frame
Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Secondary Outcome Measure Information:
Title
Changes in heart failure self-care
Description
Self-Care of Heart Failure Index
Time Frame
Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Title
Changes in instrumental activities of daily living
Description
Functional Activities Questionnaire (for both patients and informants)
Time Frame
Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Title
Changes in instrumental activities of daily living
Description
Everyday Problems Test (performance-based, for patient only)
Time Frame
Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Title
Changes in health-related quality of life
Description
Minnesota Living with Heart Failure Questionnaire
Time Frame
Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Title
Dementia-free survival
Description
Survival status (alive or deceased) at year collected from electronic health records
Time Frame
1 year after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
We will use a two-step process to screen and enroll the patients. First, we will screen potentially eligible patients from the Indiana University Health systems using these eligibility criteria. Inclusion Criteria: ≥ 55 years; chronic HF Stage C validated from echocardiography or comparable measure; ability to communicate in English; a someone (e.g., family member, significant other, close friend) who agrees to serve as an informant and provide information of the patient's IADL; and 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. Exclusion Criteria: 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 by: 1) having MoCA score 23 and lower; and 2) not meeting criteria for dementia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miyeon Jung, PhD, RN
Phone
317-274-4360
Email
miyjung@iu.edu
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miyeon Jung

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Virtual Reality and Computerized Cognitive Intervention for Mild Cognitive Impairment in Heart Failure

We'll reach out to this number within 24 hrs