Heart FailureCORENCT04485507
COgnitive Intervention to Restore Attention Using Nature Environment
A study testing Nature-VR and Urban-VR in people with Heart Failure and Cognitive Dysfunction, run by Indiana University at 1 site in United States.
Trial summary
Heart failure is a prevalent and serious public health concern with the growing aging population. Patients with heart failure often experience attention impairment that decreases their ability to perform self-care and diminishes their health-related quality of life. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure, Cognitive Dysfunction
- What is being tested?
- Nature-VR and Urban-VR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 8 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults (> 21 years)
- diagnosed with chronic HF Stage C
- able to communicate in English
Who cannot join
- uncorrected visual impairment
- major neurological disease (e.g., Alzheimer disease, Parkinson's disease)
- major psychiatric disease (e.g., schizophrenia, bipolar disease)
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Nursing
Indianapolis, Indiana, 46202
About this study
Official title: A Virtual Reality Intervention to Improve Attention in Heart Failure Patients
Heart failure is a prevalent and serious public health concern with the growing aging population. Patients with heart failure often experience attention impairment that decreases their ability to perform self-care and diminishes their health-related quality of life. In past studies, 15 - 27% of heart failure patients had attention impairment. Attention is fundamental to human activities including self-care management of heart failure. However, cognitive interventions focusing on attention are scarce in heart failure literature. This study focuses on developing a novel cognitive intervention specifically targeting improved attention and testing its efficacy on improving attention, self-care, and health-related quality of life.
The investigators in this study are asking the following 3 questions: 1) does the newly developed cognitive intervention using immersive virtual reality technology (Nature-VR) improve attention compared with the control condition (Urban-VR)?; 2) does Nature-VR intervention improve HF self-care and health-related quality of life compared with Urban-VR control condition?; and 3) are selected biological factors associated with attention function in HF?
The virtual reality-based cognitive intervention (Nature-VR) can be an efficacious intervention for the patients to use and enjoy without burdening already reduced attention. This study has great potential to improve attention and prevent attention impairment, thereby leading to healthier lives among heart failure patients.
Read the detailed description
Heart failure (HF) is a prevalent serious chronic illness that affects 6.5 million American. Among HF patients, prevalence of attention impairment is reported as 15-27%. Attention is fundamental to human activities including HF self-care. However, cognitive interventions focusing on attention are scarce in HF. The investigators developed a new cognitive intervention with immersive virtual reality technology and created a prototype of the virtual reality-based natural restorative environment intervention (Nature-VR). The prototype was feasible and showed larger effects in improving attention among 10 HF patients.
In this 2-group randomized controlled pilot study, specific aims are to: 1) examine preliminary efficacy of Nature-VR compared with Urban-VR on improving attention; 2) examine preliminary efficacy of Nature-VR compared with Urban-VR on HF self-care and health-related quality of life; and 3) explore possible biomarkers of attention in HF. This study is important and novel because this is the first intervention study targeting attention using virtual reality technology and investigating possible biomarkers associated with attention in HF patients.
- Conditions
- Heart Failure, Cognitive Dysfunction
- Being tested
- Nature-VR, Urban-VR
- 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.
Nature-VROther
Viewing 360 degree nature pictures delivered by a virtual reality headset for 10 minutes/day, 5 days/week for 4 weeks (total of 200 minutes).
Urban-VROther
Viewing 360 degree urban pictures delivered by a virtual reality headset for 10 minutes/day, 5 days/week for 4 weeks (total of 200 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Nature-VR | Experimental | Viewing 3D pictures of natural environments Receives: Other: Nature-VR |
| Urban-VR | Active comparator | Viewing 3D pictures of urban environments Receives: Other: Urban-VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in attention - Multi-Source Interference Task
Performances on the computerized cognitive test of Multi-Source Interference Task will be examined in terms of speed and accuracy. Participants are instructed to identify the target number, which is different than the other 3 numbers provided on the computer screen. There are two types of trials, congruent and incongruent. Congruent trials have a target number that is always matched its position on the button (e.g., 100, 020, or 223), in contrast, incongruent trials have the target number that is never matched with it position in the button (e.g., 010, 233, or 232). Faster response time and lower error rates indicate better attention.
Measured: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
Changes in attention - Digit Span Test
Participants are instructed to remember the sequence of numbers the data collector told and repeat the numbers right after the instructor finished talking. This test has 2 subsets, Forward-repeat exactly the same sequence, and Backward-repeat the numbers in the backward from last to the first. More digits correctly repeated indicate better attention.
Measured: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
Changes in attention - Trail Making Test
This traditional cognitive test of attention is a paper-pencil based measure and has 2 parts. Part A requires participants to connect a series of randomly arrayed, distinct circles numbered 1 to 25 in correct order as quickly as possible. Part B requires participants to connect a series of 25 circles numbered 1 to 13 randomly intermixed with letters from A to L, alternating between numbers and letters, and proceeding in ascending order (e.g., 1-A-2-B-3 and so on). Faster response time in seconds indicates better attention.
Measured: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
Changes in attention - Stroop Test
Stroop Test is a color-word test measuring the ability to processe different visual features and ignore distractions. The test has 2 parts of reading letters of color names and colors of color names using 4 color names (i.e., red, blue, yellow, and green). Congruent trials have the same letters and colors of the color names (i.e., red in red color). Incongruent trials have different letters and colors of the color names (i.e., red in blue color). Faster response time and lower error rates indicate better attention.
Measured: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
Changes in attention - Attentional Function Index
This self-reported questionnaire has 13 items on 0 to 10 response scales asking effectiveness in behaviors requiring attention. Higher scores indicate better subjective attention
Measured: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
Secondary outcomes (2)
Changes in the Self-Care of Heart Failure Index (SCHFI)
This self-reported questionnaire consists of 29 items divided into 3 scales measuring self-care maintenance, symptom perception, and self-care management. In addition, self-care confidence is measured by additional 10 items. Each scale is scored separately and standardized to achieve a possible score of 0 to 100. Higher scores indicate better self-care of HF.
Measured: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
Changes in Minnesota Living with Heart Failure Questionnaire (LHFQ)
Minnesota Living with Heart Failure Questionnaire will be used to measure health-related quality of life. This self-report questionnaire consists of 21 items on which patients are asked to rate how their HF condition impacted their physical and emotional health. Lower scores indicate better HRQL.
Measured: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Jul 2020
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
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.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Two-group randomized controlled pilot study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Miyeon Jung, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485507
- Sponsor's protocol ID
- 1904370750
- Acronym
- CORE
- Status last verified
- Apr 2024
- First submitted
- 14 Jul 2020
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Reality Intervention to Improve Attention in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT04485507
- Acronym / sponsor ID
- CORE / 1904370750
- Conditions
- Heart Failure, Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 24 Jul 2020 (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.
Heart failure is a prevalent and serious public health concern with the growing aging population. Patients with heart failure often experience attention impairment that decreases their ability to perform self-care and diminishes their health-related quality of life. In past studies, 15 - 27% of heart failure patients had attention impairment. Attention is fundamental to human activities including self-care management of heart failure. However, cognitive interventions focusing on attention are scarce in heart failure literature. This study focuses on developing a novel cognitive intervention specifically targeting improved attention and testing its efficacy on improving attention, self-care, and health-related quality of life.
The investigators in this study are asking the following 3 questions: 1) does the newly developed cognitive intervention using immersive virtual reality technology (Nature-VR) improve attention compared with the control condition (Urban-VR)?; 2) does Nature-VR intervention improve HF self-care and health-related quality of life compared with Urban-VR control condition?; and 3) are selected biological factors associated with attention function in HF?
The virtual reality-based cognitive intervention (Nature-VR) can be an efficacious intervention for the patients to use and enjoy without burdening already reduced attention. This study has great potential to improve attention and prevent attention impairment, thereby leading to healthier lives among heart failure patients.
Detailed description
Heart failure (HF) is a prevalent serious chronic illness that affects 6.5 million American. Among HF patients, prevalence of attention impairment is reported as 15-27%. Attention is fundamental to human activities including HF self-care. However, cognitive interventions focusing on attention are scarce in HF. The investigators developed a new cognitive intervention with immersive virtual reality technology and created a prototype of the virtual reality-based natural restorative environment intervention (Nature-VR). The prototype was feasible and showed larger effects in improving attention among 10 HF patients.
In this 2-group randomized controlled pilot study, specific aims are to: 1) examine preliminary efficacy of Nature-VR compared with Urban-VR on improving attention; 2) examine preliminary efficacy of Nature-VR compared with Urban-VR on HF self-care and health-related quality of life; and 3) explore possible biomarkers of attention in HF. This study is important and novel because this is the first intervention study targeting attention using virtual reality technology and investigating possible biomarkers associated with attention in HF patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-group randomized controlled pilot study
| Arm | Type | Receives |
|---|---|---|
| Nature-VR | Experimental | Other: Nature-VRViewing 3D pictures of natural environments |
| Urban-VR | Active comparator | Other: Urban-VRViewing 3D pictures of urban environments |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults (> 21 years)
- diagnosed with chronic HF Stage C
- able to communicate in English
Key exclusion criteria (3 listed)
- uncorrected visual impairment
- major neurological disease (e.g., Alzheimer disease, Parkinson's disease)
- major psychiatric disease (e.g., schizophrenia, bipolar disease)
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 |
|---|---|---|
| Nature-VRViewing 360 degree nature pictures delivered by a virtual reality headset for 10 minutes/day, 5 days/week for 4 weeks (total of 200 minutes). | Other | Nature-VR |
| Urban-VRViewing 360 degree urban pictures delivered by a virtual reality headset for 10 minutes/day, 5 days/week for 4 weeks (total of 200 minutes). | Other | Urban-VR |
Primary outcome
Changes in attention - Multi-Source Interference Task
Time frame: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
Performances on the computerized cognitive test of Multi-Source Interference Task will be examined in terms of speed and accuracy. Participants are instructed to identify the target number, which is different than the other 3 numbers provided on the computer screen. There are two types of trials, congruent and incongruent. Congruent trials have a target number that is always matched its position on the button (e.g., 100, 020, or 223), in contrast, incongruent trials have the target number that is never matched with it position in the button (e.g., 010, 233, or 232). Faster response time and lower error rates indicate better attention.
Changes in attention - Digit Span Test
Time frame: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
Participants are instructed to remember the sequence of numbers the data collector told and repeat the numbers right after the instructor finished talking. This test has 2 subsets, Forward-repeat exactly the same sequence, and Backward-repeat the numbers in the backward from last to the first. More digits correctly repeated indicate better attention.
Changes in attention - Trail Making Test
Time frame: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
This traditional cognitive test of attention is a paper-pencil based measure and has 2 parts. Part A requires participants to connect a series of randomly arrayed, distinct circles numbered 1 to 25 in correct order as quickly as possible. Part B requires participants to connect a series of 25 circles numbered 1 to 13 randomly intermixed with letters from A to L, alternating between numbers and letters, and proceeding in ascending order (e.g., 1-A-2-B-3 and so on). Faster response time in seconds indicates better attention.
Changes in attention - Stroop Test
Time frame: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
Stroop Test is a color-word test measuring the ability to processe different visual features and ignore distractions. The test has 2 parts of reading letters of color names and colors of color names using 4 color names (i.e., red, blue, yellow, and green). Congruent trials have the same letters and colors of the color names (i.e., red in red color). Incongruent trials have different letters and colors of the color names (i.e., red in blue color). Faster response time and lower error rates indicate better attention.
Changes in attention - Attentional Function Index
Time frame: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
This self-reported questionnaire has 13 items on 0 to 10 response scales asking effectiveness in behaviors requiring attention. Higher scores indicate better subjective attention
2 secondary outcomes
Changes in the Self-Care of Heart Failure Index (SCHFI)
Time frame: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
Changes in Minnesota Living with Heart Failure Questionnaire (LHFQ)
Time frame: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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 Nature-VR and Urban-VR in people with Heart Failure and Cognitive Dysfunction, 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 17 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 attention - Multi-Source Interference Task (time frame: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks). The study lists 5 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 17 Apr 2024.