Mild DementiaNCT03722316
Nature Video to Improve Older Adult Health: A Feasibility Study.
A study testing Immersive Nature Video and Neutral Video in people with Mild Dementia and Mild Cognitive Impairment, run by University of Southern California at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Dementia, Mild Cognitive Impairment
- What is being tested?
- Immersive Nature Video and Neutral Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jan 2019to 3 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- Self-reported phobias that could be triggered by nature-based videos
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Front Porch Center for Innovation and Wellbeing
Glendale, California, 91203
University of Southern California
Los Angeles, California, 90089-9003
About this 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.
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.
Read more
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.
- Conditions
- Mild Dementia, Mild Cognitive Impairment
- Being tested
- Immersive Nature Video, Neutral Video
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Nature VideoOther
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 VideoOther
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.
| Study group | Role | What they receive |
|---|---|---|
| MCI/Mild Dementia | Experimental | 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. Receives: Other: Immersive Nature Video; Other: Neutral Video |
| Healthy Older Adults | Active comparator | 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. Receives: Other: Immersive Nature Video; Other: Neutral Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Initiation of recruitment, through study completion. Average of 6 months.
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.
Measured: Initiation of recruitment, through study completion. Average of 6 months.
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.
Measured: Initiation of recruitment, through study completion. Average of 6 months.
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.
Measured: Day 1 and Day 2 - separated by one week
Secondary outcomes (5)
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.
Measured: Day 1 and Day 2 - separated by one week
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.
Measured: Day 1 and Day 2 - separated by one week
Heart rate variability
Heart rate will be defined using blood volume pulse signal captured by the E4 empatica wrist monitor.
Measured: Day 1 and Day 2 - separated by one week
Skin conductance activity
Stress/excitement will be defined using skin conductivity changes captured by the E4 empatica wrist monitor.
Measured: Day 1 and Day 2 - separated by one week
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).
Measured: Day 1 and Day 2 - separated by one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start14 Jan 2019
- Primary completion1 Oct 2019
- Study completion3 Feb 2022
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild DementiaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Front Porch Center for Innovation and Wellbeing
- Responsible party
- Principal investigator, Stacey L. Schepens Niemiec, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722316
- Sponsor's protocol ID
- NatureFeasibility2018
- Status last verified
- Mar 2022
- First submitted
- 23 Oct 2018
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Nature-based Multimedia Videos to Improve Health in Older Adults With and Without Mild Cognitive Complaints: A Feasibility and Pilot Study.
- ClinicalTrials.gov ID
- NCT03722316
- Acronym / sponsor ID
- NatureFeasibility2018
- Conditions
- Mild Dementia, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Front Porch Center for Innovation and Wellbeing
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCI/Mild Dementia | Experimental | Other: Immersive Nature Video, Other: Neutral VideoTwenty 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. |
| Healthy Older Adults | Active comparator | Other: Immersive Nature Video, Other: Neutral VideoParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Self-reported phobias that could be triggered by nature-based videos
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Nature VideoAn 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. | Other | Healthy Older Adults, MCI/Mild Dementia |
| Neutral VideoThis 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. | Other | Healthy Older Adults, MCI/Mild Dementia |
Primary outcome
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.
5 secondary outcomes
Momentary affective state
Time frame: Day 1 and Day 2 - separated by one week
Working memory
Time frame: Day 1 and Day 2 - separated by one week
Heart rate variability
Time frame: Day 1 and Day 2 - separated by one week
Skin conductance activity
Time frame: Day 1 and Day 2 - separated by one week
Quality of social communication
Time frame: Day 1 and Day 2 - separated by one week
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Nature Video and Neutral Video in people with Mild Dementia and Mild Cognitive Impairment, run by University of Southern California at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants Retained (time frame: Initiation of recruitment, through study completion. Average of 6 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.