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A-Health RCT: Effects of Participatory Art-based Activity on Health of Older Community Dwellers (A-Health-RCT)

8. februar 2021 oppdatert av: Olivier Beauchet, Jewish General Hospital

Effects of the Montreal Museum of Fine Arts Participatory Art-based Activity on Health of Older Community Dwellers: THE A-HEALTH RCT STUDY

The overall objective of the study is to examine the effects of the Montreal Museum of Fine Arts (MMFA) participatory art-based activity on wellbeing, quality of life and health condition in older community dwellers.

Aging is often associated with worsening health and withdrawal from social activities, both increasing the risk of a poor quality of life. It has been reported that the practice of art, especially participatory art-based activity enhances wellbeing, quality of life and health condition of patients and older adults. Since October 2015, the Montreal Museum of Fine Arts (MMFA; Quebec, Canada) has successfully initiated a participatory art-based activity known as "Les Beaux-Jeudis" for older community dwellers living in Montreal. Recently, the investigator demonstrated that the MMFA participatory art-based activity improved wellbeing, quality of life and health condition of Montreal older community dwellers using a pre-post single arm, prospective and longitudinal design: it was not a randomized controlled trial (RCT) which is the gold standard to examine the effects of an intervention.

Studieoversikt

Detaljert beskrivelse

Background. Recently, the investigator demonstrated that the Montreal Museum of Fine-Arts (MMFA) participatory art-based activity improved wellbeing, quality of life and health condition of Montreal older community dwellers using a pre-post single arm, prospective and longitudinal design. The main limitation of this pilot study was its design: it was not a randomized controlled trial (RCT) which is the gold standard to examine the effects of an intervention.

Objectives. The overall objective is to examine the effect of the MMFA participatory art-based activity on wellbeing, quality of life and health condition in older community dwellers.

The specific objectives are to compare the changes in 1) wellbeing, 2) quality of life and 3) health condition in older community dwellers participating in the museum participatory art-based activity (Intervention group) and in age and sex-matched older community dwellers who are not participants in the museum participatory art-based activity (Control group) during the same period of time. In addition, the compliance to museum participatory art-based activity in intervention will be examined. A second study, based on the same process, has been proceeded in Japan (Tokyo). With merging the 2 databases, we will study the impact of cultural specificities, comparing data collected in Montreal and data collected in Tokyo.

Methods. The design is a unicentre (Jewish General Hospital; Montreal, Quebec, Canada), clinical, randomized, controlled, single blinded (i.e.; investigators), superiority trial, with two parallel arms (Intervention and Control groups), comparative (comparison of Intervention and Control groups) and analyzed with the intention-to-treat.

The participants in the Intervention group will be participants of the museum participatory art-based activity. The Control group will be composed of older community dwellers matched on age and sex compared to the Intervention group but who will not be participate to the museum participatory art-based activity.

The follow-up period will be 3 months, which is the duration of a session of the museum participatory art-based activity. Assessment of wellbeing, quality of life and health condition will be performed at baseline, at the beginning of second and third months, and at the end of third month.

The same study has been developed and realized in Japan. Data collected in Canada will be merged with data collected in Japan and the analysis will be repeated for this international database.

Studietype

Intervensjonell

Registrering (Faktiske)

235

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Quebec
      • Montréal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Tokyo, Japan
        • Arts Alive

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

65 år og eldre (Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Being 65 years and over
  2. Having an Internet access with an electronic device (i.e.; laptop, computer, smartphone, tablet) at the participant's place of living as the repetitive assessments for this study will be performed on the web platform of the Centre of Excellence on Longevity of McGill University
  3. Understanding and writing the language of the recruitment centre (i.e., French or English or Japanese)
  4. Life expectancy estimated over 3 months as the duration of the follow-up is 3 months

Exclusion Criteria:

  1. concomitant participation to another clinical trial,
  2. having participated to a participatory art-based activity of the museums,
  3. not speaking the language of the study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervention group
The participants in the Intervention group will be participants of the museum participatory art-based activity.

The intervention is a participatory art-based activity which consists in making art in group, involving the participants directly in the creative process, allowing them to become co-authors of the work.

In Montreal, Canada, participants will meet once per week for a 2h workshop from 2.00 PM to 4.00 PM at the MMFA in a dedicated room during a three month-period defining "a session". Two successive sessions will be setup; a winter and a spring sessions. Each session will be composed of 12 consecutive workshops.

In Tokyo, Japan, participants will meet once per week for a 2h workshop at the Tokyo Fuji Museum in a dedicated room during a three month-period defining "a session". The session will be composed of 12 consecutive workshops.

Ingen inngripen: Control Group
The Control arm will be composed of older community dwellers matched on age and sex compared to the Intervention group but who will not be participants at the museum participatory art-based activity.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Health condition assessed by self-administered questionnaire (SAQ)
Tidsramme: 3 months
self-administered questionnaire (SAQ), score between 0 and 18, a higher score means a higher frailty
3 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Tilfredshet med prosjektet vurdert ved eget spørreskjema
Tidsramme: 1 dag
selvspørreskjema, kvalitativ (fra 1 til 10: Misfornøyd til tilfredsstillende), INGEN GLOBAL POENG, hvert spørsmål vurderes separat. Et gjennomsnitt av alle spørsmål for å ha et globalt notat (/10) vil til slutt bli gjort for hver deltaker.
1 dag
Ability to use a computer assessed by Computer proficiency questionnaire self-questionnaire (CPQ)
Tidsramme: 1 day
Computer proficiency questionnaire self-questionnaire, self-estimation of different tasks on informatics devices quoted from Never tried to Very easily (high score for proficiency in informatics). Score for each categories is calculated from the mean of the sub-questions scored from 0 to 4
1 day
Well-being assessed by Warwick-Edinburgh Mental Well-being Scale self-questionnaire
Tidsramme: 3 months
Warwick-Edinburgh Mental Well-being Scale self-questionnaire, quoting statement of feelings and thought from None of the Time to All of the time, scoring from 14 to 70 (high score for a good well-being)
3 months
Quality of life of participants assessed by EuroQol-5D self-questionnaire
Tidsramme: 3 months
EuroQol-5D self-questionnaire, evaluating mobility, usual activities, self-care, pain, anxiety and mood, from No problem to Unable, scored from 5 to 25, High score meaning a bad quality of life
3 months
Compliance assessed counting the number of workshops completed during the 3-month period of intervention.
Tidsramme: 3 months
assessed counting the number of workshops completed during the 3-months period of intervention.
3 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. januar 2019

Primær fullføring (Faktiske)

1. desember 2019

Studiet fullført (Faktiske)

1. desember 2020

Datoer for studieregistrering

Først innsendt

18. september 2018

Først innsendt som oppfylte QC-kriteriene

18. september 2018

Først lagt ut (Faktiske)

20. september 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. februar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. februar 2021

Sist bekreftet

1. februar 2021

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2019-1493

Plan for individuelle deltakerdata (IPD)

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NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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