An interventional study of Active Social Conversation in Social Isolation, Mental Status Change and Cognitive Impairment, sponsored by George Mason University. Completed at 1 site in United States. Open to participants aged 65 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-04.
Sponsored by George Mason University · Not applicable, Interventional, and Prevention
The purpose of this community-engaged project is to examine how taking part in different arts (dance \& music), compared to control (no arts) affects older adults' Health-Related Quality of Life (HRQoL using the Short Form-20(SF) form), physical performance (Short Physical Performance Battery-SPPB), cognition (using the Montreal Cognitive Assessment-MoCA), social engagement (National Social Life, Health, \& Aging Project-NSHAP survey), and perceptions of self (focus interviews).
In this Randomized-Controlled-Trial, 60 adults (20/condition) will take part in 20, 45-minute sessions (ballroom dance, ukulele/guitar playing, or control- i.e. social conversation), 2 times/week for 10 weeks.
While the investigators know that arts participation improves function in older adults, exact effects of different arts programs on health outcomes remains unclear.
The investigators plan to fill this gap by studying how different arts participation affect health outcomes.
The overall aim is to study how arts engagement helps older adults remain active and influences physical, psychological, and emotional functioning.
75 studies on the registry are indexed under Social Isolation; 39 are open to participants now.
This study's enrollment of 64 is below the median of 80 across 66 interventional studies indexed under Social Isolation.
Browse Social Isolation studies →George Mason University is the lead sponsor of 43 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
The Dance group participants will take part in ballroom dance lessons twice/week for 45-minutes/session for 10 weeks
Other: Active Social Conversation
The Music group participants will take part in ukulele lessons twice/week for 45-minutes/session for 10 weeks
Other: Active Social Conversation
The Control group participants will meet 2 times per week for 45-minutes/session for 10 weeks to participate in a social conversational group for 10 weeks
Other: Active Social Conversation
Active Social Conversation
Also known as: Active Control
Change in Physical Performance using the Short Physical Performance Battery (SPPB)
The Short Physical Performance Battery (SPPB) is an assessment tool for evaluation of lower extremity functioning in older persons. In this tool, participants will perform the 3 SPPB components: 1) Ability to stand for 10 sec with feet in 3 different positions (together side-by-side, semi-tandem, and tandem), 2) Two timed trials of a 4-m walk (fastest recorded), and 3) Time to rise from a chair five times. The subtests are scored from 0-4. The overall SPPB is scored from 0 (Minimum) to 12 (Maximum score) with higher scores indicating better lower extremity function.
Time frame: Pre (Week 0), Post 1 (Week 10) and Post 2 (Week 15) Intervention
Change in Cognition using Montreal Cognitive Assessment (MOCA) survey
The Montreal Cognition Assessment (MoCA) is a brief, 30-question test designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. MoCA scores range between 0-30. A score of 26 or over is considered normal.
Time frame: Pre (Week 0), Post 1 (Week 10) and Post 2 (Week 15) Intervention
Change in Self-Perception Post Intervention Focus Interview
In these interviews participants discuss how they self-perceive any physical, mental, and social changes they underwent as a result of taking part in the interventions
Time frame: Post 1 (Week 10) and Post 2 (Week 15) Intervention
Change in Social Connections using the Social Connections Survey
Participants complete questions from the National Social Life, Health, and Aging Project (NSHAP) measure perceived social connection and isolation. These questions ask participants about 1) Support from partner (we are using 3 of the 6 questions); 2) Support from family (we are using 3 of the 5 questions); 3) Support from friends (we are using 3 of the 5 questions). All questions are on a 4-point frequency range from "never" to "often", except for 2 questions. Question #1 construct one is on a 7-point scale from "very unhappy to "very happy" and question #5 construct two is on a 6-point scale from "none" to "more than 20". The 7 items with the same frequency anchors will be summed; the other two items will be analyzed as one-item indicators.
Time frame: Post 1 (Week 10) and Post 2 (Week 15) Intervention
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2019 to primary completion in Apr 2020, 7 months.
Of 52 non-industry interventional studies with no phase under Social Isolation, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 40. This study's 7 months is below that.
Counting every sponsor, half of 52 studies reached it within 27 months; a quarter within 16 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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George Mason University