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

Primary Purpose

Mild Dementia, Mild Cognitive Impairment

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immersive Nature Video
Neutral Video
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Dementia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Front Porch Center for Innovation and Wellbeing
  • University of Southern California

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MCI/Mild Dementia

Healthy Older Adults

Arm Description

Twenty participants will be allocated to this arm if they demonstrate mild impairments in cognition based on a cognitive screening phase. Participants enrolled in this arm will be arranged in groups of 5. They will attend a paperwork visit and two video-viewing sessions (order is randomized) held approximately one week apart: (1) brief immersive nature-based video experience + group discussion and (2) comparison condition that includes presentation of a relatively "neutral," un-arousing documentary + group discussion. Each video lasts approximately 15 minutes. Using a semi-structured group discussion guide, participants will be prompted to talk about what they saw in the video and relate video content to their own lives and experiences.

Participants are allocated to this arm if they demonstrate healthy cognition based on a cognitive screening phase. Participants enrolled in this arm will be arranged in groups of 5. They will attend a paperwork visit and two video-viewing sessions (order is randomized) held approximately one week apart: (1) brief immersive nature-based video experience + group discussion and (2) comparison condition that includes presentation of a relatively "neutral," un-arousing documentary + group discussion. Each video lasts approximately 15 minutes. Using a semi-structured group discussion guide, participants will be prompted to talk about what they saw in the video and relate video content to their own lives and experiences.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
Heart rate variability
Heart rate will be defined using blood volume pulse signal captured by the E4 empatica wrist monitor.
Skin conductance activity
Stress/excitement will be defined using skin conductivity changes captured by the E4 empatica wrist monitor.
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).

Full Information

First Posted
October 23, 2018
Last Updated
March 23, 2022
Sponsor
University of Southern California
Collaborators
Front Porch Center for Innovation and Wellbeing
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1. Study Identification

Unique Protocol Identification Number
NCT03722316
Brief Title
Nature Video to Improve Older Adult Health: A Feasibility Study.
Official Title
Immersive Nature-based Multimedia Videos to Improve Health in Older Adults With and Without Mild Cognitive Complaints: A Feasibility and Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
The presentation of the pandemic made recruitment and implementation impossible for this unfunded study to be completed. We were unable to continue after the loss of key resources.
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
February 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Front Porch Center for Innovation and Wellbeing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Dementia, Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MCI/Mild Dementia
Arm Type
Experimental
Arm Description
Twenty participants will be allocated to this arm if they demonstrate mild impairments in cognition based on a cognitive screening phase. Participants enrolled in this arm will be arranged in groups of 5. They will attend a paperwork visit and two video-viewing sessions (order is randomized) held approximately one week apart: (1) brief immersive nature-based video experience + group discussion and (2) comparison condition that includes presentation of a relatively "neutral," un-arousing documentary + group discussion. Each video lasts approximately 15 minutes. Using a semi-structured group discussion guide, participants will be prompted to talk about what they saw in the video and relate video content to their own lives and experiences.
Arm Title
Healthy Older Adults
Arm Type
Active Comparator
Arm Description
Participants are allocated to this arm if they demonstrate healthy cognition based on a cognitive screening phase. Participants enrolled in this arm will be arranged in groups of 5. They will attend a paperwork visit and two video-viewing sessions (order is randomized) held approximately one week apart: (1) brief immersive nature-based video experience + group discussion and (2) comparison condition that includes presentation of a relatively "neutral," un-arousing documentary + group discussion. Each video lasts approximately 15 minutes. Using a semi-structured group discussion guide, participants will be prompted to talk about what they saw in the video and relate video content to their own lives and experiences.
Intervention Type
Other
Intervention Name(s)
Immersive Nature Video
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Neutral Video
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of Participants Retained
Description
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.
Time Frame
Initiation of recruitment, through study completion. Average of 6 months.
Title
Recruitment rate
Description
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.
Time Frame
Initiation of recruitment, through study completion. Average of 6 months.
Title
Frequency and type of implementation barriers
Description
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.
Time Frame
Initiation of recruitment, through study completion. Average of 6 months.
Title
Number of discussion questions used during group discussion
Description
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.
Time Frame
Day 1 and Day 2 - separated by one week
Secondary Outcome Measure Information:
Title
Momentary affective state
Description
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.
Time Frame
Day 1 and Day 2 - separated by one week
Title
Working memory
Description
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.
Time Frame
Day 1 and Day 2 - separated by one week
Title
Heart rate variability
Description
Heart rate will be defined using blood volume pulse signal captured by the E4 empatica wrist monitor.
Time Frame
Day 1 and Day 2 - separated by one week
Title
Skin conductance activity
Description
Stress/excitement will be defined using skin conductivity changes captured by the E4 empatica wrist monitor.
Time Frame
Day 1 and Day 2 - separated by one week
Title
Quality of social communication
Description
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).
Time Frame
Day 1 and Day 2 - separated by one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Front Porch Center for Innovation and Wellbeing
City
Glendale
State/Province
California
ZIP/Postal Code
91203
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-9003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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