Clinical trial NCT04485507: COgnitive Intervention to Restore Attention Using Nature Environment
Official title: A Virtual Reality Intervention to Improve Attention in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Cognitive Dysfunction
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2020-07-24
Enrollment: 74
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-group randomized controlled pilot study
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Changes in attention - Multi-Source Interference Task
timeFrame: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
measure: Changes in attention - Digit Span Test
timeFrame: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
measure: Changes in attention - Trail Making Test
timeFrame: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
measure: Changes in attention - Stroop Test
timeFrame: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
measure: Changes in attention - Attentional Function Index
timeFrame: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
Secondary outcomes:
measure: Changes in the Self-Care of Heart Failure Index (SCHFI)
timeFrame: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
measure: Changes in Minnesota Living with Heart Failure Questionnaire (LHFQ)
timeFrame: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
Other outcomes:
measure: Changes in serum brain-derived neurotrophic factor levels (serum BDNF)
timeFrame: Baseline and 4 weeks
measure: BDNF gene
timeFrame: Baseline
measure: Apolipoprotein (APOE) gene
timeFrame: Baseline
measure: Dopamine receptor gene
timeFrame: Baseline
measure: Dopamine transporter gene
timeFrame: Baseline
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Nursing
state: Indiana
Study officials:
References: