COgnitive Intervention to Restore Attention Using Nature Environment

NCT04485507 | Completed

• 1 other identifier: 1904370750
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Heart Failure; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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

  Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks

Secondary Outcomes (2)

• Changes in the Self-Care of Heart Failure Index (SCHFI)

  Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks

• Changes in Minnesota Living with Heart Failure Questionnaire (LHFQ)

  Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks

Other Outcomes (5)

• Changes in serum brain-derived neurotrophic factor levels (serum BDNF)

  Baseline and 4 weeks

• BDNF gene

  Baseline

• Apolipoprotein (APOE) gene

  Baseline

Study Arms (2)

Nature-VR

EXPERIMENTAL

Viewing 3D pictures of natural environments

Other: Nature-VR

Urban-VR

ACTIVE COMPARATOR

Viewing 3D pictures of urban environments

Other: Urban-VR

Interventions

Nature-VR OTHER

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).

Nature-VR

Urban-VR OTHER

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).

Urban-VR

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults (\> 21 years)
• diagnosed with chronic HF Stage C
• able to communicate in English

You may not qualify if:

• uncorrected visual impairment
• major neurological disease (e.g., Alzheimer disease, Parkinson's disease)
• major psychiatric disease (e.g., schizophrenia, bipolar disease)

Sponsors & Collaborators

• Indiana University: lead
• American Heart Association: collaborator

Study Sites (1)

Indiana University School of Nursing

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Heart Failure; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two-group randomized controlled pilot study

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 24, 2020
• Study Start: July 1, 2020
• Primary Completion: June 8, 2022
• Study Completion: June 8, 2022
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

US (1)