Nature Video to Improve Older Adult Health: A Feasibility Study.

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03722316
• Other study ID #: NatureFeasibility2018
• Status: Terminated
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: February 3, 2022

Study information

• Verified date: March 2022
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: February 3, 2022
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment
• Mild Dementia

Intervention

Other:
• Immersive Nature Video
An approximately 15-minute digital nature experience using work by filmmaker Louie Schwartzberg-Visual Healing by Moving Art. Time-lapse, high-speed, and macro cinematography are incorporated within each video. Audiovisual content include vivid imagery of a variety of ecosystems and climates accompanied by calming instrumental music. Both the MCI/Mild dementia arm and the healthy older adult arm will experience this intervention.
• Neutral Video
This video will include clips from relatively non-arousing educational documentaries. Fifteen minutes of documentary content will be selected from a longer video, ensuring that the content remains as neutral as possible. Video selections were modeled after the work from Eryilmaz, Van De Ville, Schwartz, and Vuilleumier (2011) who identified very brief movie clips (i.e., <1 minute) that were rated as neutral as opposed to frightful or enjoyable. Both the MCI/Mild dementia arm and the healthy older adult arm will experience this intervention.

Locations

Country	Name	City	State
United States	Front Porch Center for Innovation and Wellbeing	Glendale	California
United States	University of Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Front Porch Center for Innovation and Wellbeing

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Participants Retained	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.	Initiation of recruitment, through study completion. Average of 6 months.
Primary	Recruitment rate	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.	Initiation of recruitment, through study completion. Average of 6 months.
Primary	Frequency and type of implementation barriers	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.	Initiation of recruitment, through study completion. Average of 6 months.
Primary	Number of discussion questions used during group discussion	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.	Day 1 and Day 2 - separated by one week
Secondary	Momentary affective state	Participants' acute affective state will be assessed using the Multidimensional Mood Questionnaire (MDMQ) - English translation (Steyer, Schwenkmezger, Notz, & Eid, 1994). This 24-item questionnaire addresses degrees of unpleasantness, sleepiness, and restlessness. Items are rated on a 5-point Likert scale ranging from "not at all" to "very much." Subscale items are summed, with higher scores indicated greater well-being.	Day 1 and Day 2 - separated by one week
Secondary	Working memory	Working memory will be assessed using a single 2-back test (visual only) administered using a tablet application. In this task, participants will be presented with a digit (0 - 9) that they must temporarily memorize and then indicate if a future stimulus is the same as that digit presented 1 trial previously.	Day 1 and Day 2 - separated by one week
Secondary	Heart rate variability	Heart rate will be defined using blood volume pulse signal captured by the E4 empatica wrist monitor.	Day 1 and Day 2 - separated by one week
Secondary	Skin conductance activity	Stress/excitement will be defined using skin conductivity changes captured by the E4 empatica wrist monitor.	Day 1 and Day 2 - separated by one week
Secondary	Quality of social communication	Video recordings of group discussions will be made to capture social behaviors including communication and interaction. Recordings will subsequently be analyzed using the Holden Communication Scale (Holden & Woods, 1995). This 12-item instrument that addresses factors including conversation, awareness, pleasure, humor, and responsiveness, will be completed by research personnel who will watch and analyze video recordings of each session. Higher scores indicate more impairment with social behavior. The Holden Communication Scale has been determined a valid and reliable assessment for communication ability in persons with dementia (Strøm, Engedal, Benth, & Grov, 2016).	Day 1 and Day 2 - separated by one week