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Clinical Trials/NCT03722316
NCT03722316
Terminated
Not Applicable

Immersive Nature-based Multimedia Videos to Improve Health in Older Adults With and Without Mild Cognitive Complaints: A Feasibility and Pilot Study.

University of Southern California2 sites in 1 country25 target enrollmentJanuary 14, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Dementia
Sponsor
University of Southern California
Enrollment
25
Locations
2
Primary Endpoint
Percent of Participants Retained
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

Background: Exposure to nature has a positive impact on a multitude of health-related outcomes such as stress, attention, recovery after surgery, and overall well-being. There is growing interest in determining the impact of vicarious nature experiences delivered through multimedia platforms on the well-being of persons at high risk for poor psychosocial outcomes, as is the case in older adults diagnosed with mild cognitive impairment (MCI) or mild dementia.

Objectives/Purpose: The primary purpose of this study is to assess the feasibility of providing an immersive nature-based multimedia experience to older adults with MCI or mild dementia. A secondary purpose is to identify the potential health benefits of this intervention.

Methodology: A convenience sample of 40 older adults (65+ years old) with and without mild cognitive complaints will be recruited from a Los Angeles senior service partner. Participation will include three visits. The first visit will include the consent process, cognitive testing, and questionnaire completion. The second and third visits will consist of a video session followed immediately by a group discussion regarding the content in the videos. The two video sessions will be administered in a randomized and counterbalanced manner one week apart. One video involves a 15-minute immersive nature-based experience and the other includes a 15-minute clip that presents emotionally "neutral" educational content. Both sessions will be immediately followed by a group discussion of the content in the videos and how it relates to past experiences.

Outcomes and Analysis: Process evaluation data associated with recruitment, screening eligibility, involvement of personnel, assessment administration, and retention will be collected to determine overall study feasibility. Additionally, selected assessments will be administered at each multimedia experience during key time points to examine potential short-term health benefits.

Registry
clinicaltrials.gov
Start Date
January 14, 2019
End Date
February 3, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stacey L. Schepens Niemiec

Assistant Professor of Research

University of Southern California

Eligibility Criteria

Inclusion Criteria

  • Speaks and understands English
  • Mild cognitive impairment/mild dementia or normal cognition
  • Minor complaints with thinking or memory
  • Demonstrate the cognitive capacity to understand and consent to research procedures and to communicate his/her decision

Exclusion Criteria

  • Self-reported phobias that could be triggered by nature-based videos

Outcomes

Primary Outcomes

Percent of Participants Retained

Time Frame: Initiation of recruitment, through study completion. Average of 6 months.

The primary outcome of this study is to determine feasibility of study procedures. Retention is one component of feasibility. Retention will be measured as the % completing both video-based visits. Data will be recorded in a testing log.

Recruitment rate

Time Frame: Initiation of recruitment, through study completion. Average of 6 months.

The primary outcome of this study is to determine feasibility of study procedures. Recruitment rate is one component of feasibility. Recruitment rate will be defined as the % (of number approached) recruited over the duration of the recruitment period. We will also note % recruited from various sources. Data will be recorded in a recruitment log.

Frequency and type of implementation barriers

Time Frame: Initiation of recruitment, through study completion. Average of 6 months.

The primary outcome of this study is to determine feasibility of study procedures. Implementation barriers is one component of feasibility. Implementation barriers will be defined as the perceived challenges to assessment and intervention delivery on the part of the investigative team. Data sources will include team meeting discussions and study logs made by investigators during implementation.

Number of discussion questions used during group discussion

Time Frame: Day 1 and Day 2 - separated by one week

The primary outcome of this study is to determine feasibility of study procedures. Intervention fidelity is one component of feasibility. Intervention fidelity will be subjectively determined by adherence to group discussion guides that are paired with the video-based intervention component. Data sources will include video recordings of the group discussion and investigator study notes.

Secondary Outcomes

  • Momentary affective state(Day 1 and Day 2 - separated by one week)
  • Quality of social communication(Day 1 and Day 2 - separated by one week)
  • Working memory(Day 1 and Day 2 - separated by one week)
  • Heart rate variability(Day 1 and Day 2 - separated by one week)
  • Skin conductance activity(Day 1 and Day 2 - separated by one week)

Study Sites (2)

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