Stories in the Moment: Dance Program for People Living With Dementia

Alzheimer Disease Clinical Trial

Official title:

Stories in the Moment: Dance Program for People Living With Dementia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06221202
• Other study ID #: 23-MAGD-101
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: January 2024
• Source: DanceStream Projects
• Contact: Magda Kaczmarska, MFA
• Phone: 520-331-5726
• Email: magda.kaczmarska[@]gbhi.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the impact on the quality of life and wellbeing of a person-centered online dance program on people living with dementia or MCI and care partners. The duration of the study will be 1 year. Each participant in the study will be followed for approximately 4 months. The study includes joining a weekly 1-hour dance program online on Zoom for 12 weeks. Prior and after the dance program, participants will meet with the research coordinator to answer some questionnaires about wellbeing and reflections on their experience in the program. After the completion of the dance program, participants will be invited to join a focus group to reflect of the impact of the program with fellow participants. The study will enroll up to 72 participants. This includes 36 dyads of persons living with dementia or MCI and their care partners. The study will enroll community-dwelling people living with a diagnosis of mild cognitive impairment or mild to moderate-stage dementia and care partners living in the United States.

Description:

One third of older adults with cognitive impairment in the United States (est. 4.3 million individuals) live alone, which places them at higher levels of precarity and opens them up to the detrimental effects of isolation and stigma. Studies illuminate how the lack of appropriate services to support independent living for people with cognitive impairment influence the precarity that these older adults face, a precarity which has heightened significantly since the COVID-19 pandemic. For the 50 million people living with dementia (PLWD) globally, this lack of meaningful connection is compounded by the detrimental effects of a progressive disease which can impact affective states, mobility and spatial relationship, and ability to communicate or follow conversations. As a result, people living with dementia inevitably experience shifts in their modes and capacities for expression which influence their ability to express and feel connected to the communities around them. Reportedly, persons living with dementia and their care partners often experience a reduction in size of their social networks and loss of connection with others as the disease progresses. The COVID-19 pandemic illustrated the feasibility and benefit of virtual social engagement programs for older adults and PLWD, offering a support network from the comfort of their home. Research into virtually delivered social programs for PLWD suggest implications beyond the context of COVID-19, where virtual models may support the social connectedness of those living in geographically marginalized and underserved areas. Additionally, evaluations of telemedicine programs list preferences among PLWD and care partners citing convenience from resources and time saved, and improved access as benefits to virtual engagement. This suggests that even now after the imposed physical isolation of the pandemic have been lifted, having access to creative social programming virtually will continue to be a lifeline for PLWD. With global projections of dementia approaching 82 million people in 2030, the need for supporting and expanding networks of meaningful and stimulating connection for and with people living with dementia is evident. Increasingly, person-centered models of care for people living with dementia are becoming the gold standard globally, highlighting the necessity of creating meaningful relationships to support them. This underlines the demand for programs that engage with people living with dementia as opposed to only delivering programs at or to them. Relationality is key to meaningful citizenship and people living with dementia are not exempt from the right to it not immune to its benefits. As highlighted by Dr. Livingston, "engaging in meaningful and pleasurable activities is hypothesized to improve health and wellbeing" for people living with dementia. The benefits of these social engagements include reconnecting individuals to their physical and social environment, supporting self- esteem, building neural connections through complex interactions and promoting a sense of role continuity, purpose, or personhood, self-identity, and meaning. Dance as a multi-modal activity which couples multiple cognitive tasks with aerobic exercise and social engagement, is increasingly lauded as a social engagement for older adults and PLWD. Dance, which promotes community engagement coupled with physical fitness, is the highest preferred physical activity among diverse community residing older adults. A growing body of research illustrates the potential of dance in impacting brain health through: engaging motor control and function on multiple levels, supporting individual and social wellbeing, offsetting depression, and offering ameliorative cognitive effects through aerobic fitness and creative engagement. Additionally, social engagement, positive mood and physical activity are three of 12 modifiable risk factors for dementia, indicating the benefit of this activity across the life course. There is a need to extend the positive benefits of dance (including coordination, mood, social connection and creative engagement) to PLWD. The Stories in the Moment (SIM) program engages PLWD through dance, sensory engagement, music and storytelling while centering their participation as co-creative agents. Stories in the Moment provides tools that can help participants maintain meaningful engagement, community and connection regardless of their disease progression. The program uses co-creative dance improvisation practices to help people explore options of expression and gain comfort and security in the broad range of resources available to them in their bodies, minds, and voices. Dance is a universal language which mobilizes our bodies to tell stories in movement. SIM utilizes and extends the benefits of group dance improvisation to connect meaning and movement to build collective "stories in the moment". In co- creating these group story-dances, valuing the essential contributions of each participant regardless of their "ability", SIM supports connection, communication and the building of creative community with PLWD. There exists a paucity of understanding of the impact of dance and creative movement on the wellbeing, sense of belonging and quality of life of people living with dementia. This pilot project will deliver a creative dance program, Stories in the Moment, to diverse individuals living with dementia and their care partners residing across the U.S. A delivery of a mixed-methods evaluation of the novel Stories in the Moment program delivered virtually will allow for an informed understanding of the perceived impact of the program for people living with dementia and their care partners and in turn inform the approach to development, further optimization and scalability of this program. BACKGROUND ON STORIES IN THE MOMENT DANCE PROGRAM The Stories in the Moment program approaches implemented in this research study have been successfully prototyped since 2020 in partnership with local and national organizations and community partners serving diverse communities of people living with dementia and care partners in the United States. The Stories in the Moment program was developed and prototyped in partnership with people living with dementia and their care partners through the Virtual Engagement Program on the Dementia Action Alliance (DAA) (2021). The curriculum and practical approach were informed by the 20-year experience of the PI as a dance artist and builder of community-based dance programs for intergenerational groups and older adults. Leveraging this practical experience with a background in neuropharmacology and a rigorous and systematic review of peer- reviewed literature on the effects of dance on brain health for healthy older adults and PLWD, shaped the Stories in the Moment framework and methodology. SAMPLE SIZE Up to 36 people living with dementia will be selected to join the study. Up to 36 care partners or collateral (a family member, paid caregiver, or close friend who spends at least 8 hours/week with the person living with dementia and speaks fluent English) who also consent to participate in the study will be included. RESEARCH LOCATION All research activities for this study will take place online through the Zoom videoconferencing platform. Participants in the virtual dance program will be joining from multiple locations around the United States from their personal devices and most often from their homes or places of residence. PROCEDURES 1. Prior to the start of the research study, potential participants will meet with the research coordinator to complete a consent interview. 2. Pre-dance program intervention questionnaires: (a) basic demographic questionnaire, (b) WHO-5 scale of wellbeing adapted for people living with dementia, (c) anxiety (Rating for Anxiety in Dementia-Scheduled Interview designed for evaluators without extensive clinical training) and (d) loneliness (6-item De Jong Gierveld Loneliness Scale) as well as a (e) qualitative questionnaire evaluating interest and expectations in joining the Stories in the Moment program. The questionnaires will be delivered via a conversation with a researcher over the telephone or a videoconferencing platform. The pre-intervention questionnaires will take approximately 20 minutes to complete. 3. Over the course of three months (12 weeks) of the intervention, study participants will join once a week for an hour on a videoconference call (Zoom) to engage in the dance program, Stories in the Moment for a total of 12 sessions. Participants will be assigned to one of up to 3 virtual classes based on their time zone and availability for the duration of the 12-week series. During the Stories in the Moment class session, the activities will alternate between self-created (their own) movements and activities demonstrated by the teaching artist (to follow). All activities will be performed seated and are adjusted to provide best practices in progression of movements for older adults and individuals with limited mobility. As the nature of the program is co-creative, meaning the participants guide the movements selected, participants will be invited, at all times, to participate in a way that feels good to them. Researchers will track attendance and de-identified field notes of participant responses and participation as well as teaching artist approaches and adaptations will be documented. 4. Immediately following the 12-week intervention of Stories in the Moment, study participants (people living with dementia and care partners/a collateral who also consented to participate in the study) will be invited to participate in a focus group. The focus group will last up to an hour on a videoconference (Zoom) platform. Persons living with dementia and care partners/collateral will be asked to describe their experience with the Stories in the Moment program. 5. Post-dance intervention questionnaires: (a) WHO-5 scale of wellbeing adapted for people living with dementia, (c) anxiety (Rating for Anxiety in Dementia-Scheduled Interview designed for evaluators without extensive clinical training) and (d) loneliness (6-item De Jong Gierveld Loneliness Scale), (d) belonging (Sense of Belonging Scale) as well as a (e) questionnaire with open ended questions evaluating their perceptions and reflections in joining the Stories in the Moment program. The questionnaires will be delivered via a conversation with a researcher over the telephone or a videoconferencing platform. The post-intervention questionnaires will take approximately 40 minutes to complete. Magda Kaczmarska is an Atlantic Fellow for Equity in Brain Health at the Global Brain Health Institute (GBHI). This research is supported with funding from GBHI, Alzheimer's Association, and Alzheimer's Society (GBHI ALZ UK-22-865612).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: October 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Criteria:

Inclusion Criteria (person living with dementia):

• age 50 or older
• a self-reported mild cognitive impairment or dementia diagnosis and mild-moderate dementia severity (confirmed by care partner or collateral)
• a care partner or a collateral (a family member, paid caregiver, or close friend who spends at least 8 hours/week with the person living with dementia and speaks fluent English) who consents to join the study
• English fluency, categorized as not requiring translation into another language. Being non-verbal or having limited verbal ability will not be considered exclusion criteria but this condition will be noted.
• access to and basic ability to use the videoconferencing platform (Zoom) on a digital device (tablet, telephone or computer) (or access to support therein). Inclusion criteria (care partner or a collateral - defined as a family member, paid caregiver, or close friend who spends at least 8 hours/week with the person living with

dementia):

• age 18 and older
• speaks fluent English
• access to and basic ability to use the videoconferencing platform (Zoom) on a digital device (tablet, telephone or computer) (or access to support therein).

Exclusion Criteria (person living with dementia):

• Persons living with dementia unable to provide consent or assent. Persons living with dementia who do not have capacity to provide consent but are capable of providing assent will be included if a care partner or collateral who is a legally authorized representative provides consent.
• Persons living with dementia with severe dementia (classified as being unable to sit up independently and being non-ambulatory within the upper extremities) will be excluded. Being non-verbal or having limited verbal ability will not be considered exclusion criteria but this condition will be noted. For these participants, attempts will be made to capture responses to questionnaires via alternative communication methods (gesture, facial expression, typing in the chat) and the care partner or collateral will be asked to corroborate or supplement the responses.
• Lack of reliable access to a digital device with Zoom application.

Exclusion criteria (care partner or a collateral):

• Lack of reliable access to a digital device with Zoom application.

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia, Primary Progressive
• Cognitive Dysfunction
• Dementia
• Dementia, Vascular
• Frontotemporal Dementia
• Lewy Body Disease
• Mild Cognitive Impairment
• Pick Disease of the Brain
• Vascular Dementia

Intervention

Other:
• Stories in the Moment Dance Program - Online
Stories in the Moment is a co-creative dance, movement and storytelling program for persons living with dementia and care partners.

Locations

Country	Name	City	State
United States	Online	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
DanceStream Projects	Alzheimer's Association

Country where clinical trial is conducted

United States, 

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wellbeing	Measurement Tool: WHO (Five) Well-Being Index (1998 version) Descriptive Name of Scale: WHO-5 Scale of Wellbeing Measurement Parameter: Wellbeing; Five statements scoring wellbeing over the last two weeks.; Scoring: Score 0-5 (0: At no time; 5: All the time) The raw score is calculated by totaling the figures of the five answers. The raw score ranges from 0 to 25, 0 representing worst possible and 25 representing best possible quality of life.; To obtain a percentage score ranging from 0 to 100, the raw score is multiplied by 4.; A percentage score of 0 represents worst possible, whereas a score of 100 represents best possible quality of life.	1-2 weeks pre 12-week dance intervention and 1-2 weeks post 12-week dance intervention
Primary	Loneliness	Measurement Tool: 6-item De Jong Gierveld Loneliness Scale Descriptive Name of Scale: A 6-item Scale for Overall, Emotional, and Social Loneliness Measurement Parameter: Loneliness; Six statements scoring sense of loneliness over the last two weeks. Three statements address emotional loneliness; three statement address social loneliness; aggregate score represented total loneliness score.; Scoring: Total loneliness score can be categorized into four levels: not lonely (score 0, 1), moderate lonely (score 2 through 4), severe lonely (score 5), and very severe lonely (score 6).	1-2 weeks pre 12-week dance intervention and 1-2 weeks post 12-week dance intervention
Primary	Anxiety	Measurement Tool: Rating Anxiety in Dementia (RAID) Descriptive Name of Scale: Rating for Anxiety in Dementia-Scheduled Interview designed for evaluators without extensive clinical training Measurement Parameter: Loneliness; 20-item scale and interview assessing anxiety severity of people living with dementia.; Scoring: U. unable to evaluate. 0. absent. 1. mild or intermittent. 2. moderate. 3. severe Rating based on symptoms and signs occurring during two weeks prior to the interview.; No score given if symptoms result from physical disability or illness. Total score is the sum of items 1 to 18. A score of 11 or more suggests significant clinical anxiety.	1-2 weeks pre 12-week dance intervention and 1-2 weeks post 12-week dance intervention
Primary	Belonging	Measurement Tool: Sense of Belonging Scale Descriptive Name of Scale: Sense of Belonging Scale adapted for dance intervention Measurement Parameter: Sense of belonging; 13 statements scoring sense of belonging and involvement.; Scoring: 5-item Likert scale ranging from Strongly Agree - Strongly Disagree. Higher score of "Strongly Agree" indicates higher sense of belonging and involvement.	1-2 weeks post 12-week dance intervention
Primary	Participant Interest, Expectations and Perceived Wellbeing and Belonging	Measurement Tool: Qualitative Questionnaire to Assess Pre-Intervention Interest, Expectations and Perceived Wellbeing and Belonging Measurement Parameter: Interest, expectations and perceived pre-intervention wellbeing and belonging; 12-item descriptive questionnaire assessing pre-intervention interest, expectations and perceived sense of physical and mental wellbeing and belonging.; Scoring: Responses are qualitative.	1-2 weeks pre 12-week dance intervention
Primary	Participant Satisfaction and Perceived Impact	Measurement Tool: Questionnaire to Assess Post-Intervention Satisfaction and Perceived Impact of Dance Intervention Measurement Parameter: Satisfaction and perceived impact on wellbeing; 20-item questionnaire assessing intervention satisfaction and perceived impact on physical and mental wellbeing.; Scoring: Yes or No responses. Yes - indicates satisfaction or perceived positive impact. Open-ended questions offer space for qualifying responses.; Maximum score of 20 indicated maximum satisfaction and perceived impact.	1-2 weeks post 12-week dance intervention
Primary	Participant focus group post-dance intervention	Measurement Tool: Semi-structure focus group made up of participants following 12-week dance intervention online on Zoom.; Measurement parameter: Satisfaction, participant feedback and perceived impact on wellbeing; Scoring: Qualitative analysis	Immediately post 12-week dance intervention
Primary	Action Research Field Notes	Measurement tool: Field notes taken by teaching artist Measurement parameter: De-identified notes by teaching artist of pedagogical and artistic observations made during the session including attendance, participant engagement, class design, facilitator delivery of content.; Scoring: Qualitative analysis	During 12-week dance intervention