- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01474616
Mobility of Vulnerable Elders (MOVE): Translating Knowledge to Health Care Aides in Long-term Care Facilities (MOVE)
25. januar 2017 oppdatert av: University of Alberta
Almost 90 percent of residents living in long-term care facilities have some type of mobility limitation, which worsens quickly once they move into a long-term care facility.
This means that they cannot easily walk or move around in their day-to-day lives and this can have serious consequences for their general health and well-being.
Researchers have shown that exercise can help the mobility of even the oldest of adults but elderly residents in long-term care facilities still commonly sit or lie in bed for long periods of time, in many cases for most of their waking hours.
The purpose of this research is to study the effect of a simple physical activity on the mobility and quality of life of residents in long-term care facilities.
Researchers will introduce a sit-to-stand activity to health care aides which will become part of their daily routine with residents.
The basic sit-to-stand movement is already a part of the daily activities that health care aides do with residents.
Specifically, health care aides will ask residents to repeat the sit-to-stand activity at mealtimes, when using the toilet, and on other occasions of daily activity.
An important part of this research is to find out how well the activity preserves the ability of residents to stay mobile and also to examine how this will improve their quality of life in the home.
The MOVE study will demonstrate whether it is possible to delay the loss of mobility in long-term care residents by incorporating the sit-to-stand activity into the regular practice of health care aides.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
113
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Alberta
-
Edmonton, Alberta, Canada, T5J 3M9
- CapitalCare Continuing Care
-
Edmonton, Alberta, Canada, T6C 4G8
- Good Samaritan Society
-
Edmonton, Alberta, Canada, T6E 6A8
- Extendicare
-
Edmonton, Alberta, Canada, T6K 2R1
- Shepherd's Care Foundation
-
-
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
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- have a diagnosis of Alzheimer disease, vascular dementia, or mixed dementia
- are able to transfer independently or with the assistance of one person
Exclusion Criteria:
- have a diagnosis of fronto-temporal or Lewy-body dementia
- require the assistance of more than one person to transfer, or a transfer lift
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Sit-to-Stand Activity
|
Health care aides will be expected to prompt residents to repeatedly stand up and sit down on four occasions throughout the day (twice on each of the day and evening shifts).
The number of repetitions on each occasion will vary according to residents' ability and fatigue.
The sit-to-stand activity is to be integrated into usual care routines such as when entering the dining room at mealtimes, while toileting, and on other occasions of regular activity.
The timing and location will be at the discretion of the health care aide.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline in Mobility at 3 and 6 months
Tidsramme: Baseline, 3-Months, 6-Months
|
The sit-to-stand action is a functional activity that has been incorporated into a number of mobility measures.
We have chosen to measure mobility using the number of sit-to-stands in 30 seconds because in the frail nursing home population many residents have difficulty transferring (e.g.standing up from a chair).
In our pilot study we found many residents were unable to complete more than two or three sit-to-stands.
Residents will be instructed to stand up and sit down as many times as possible until they are asked to stop after 30 seconds (Jones, Rikli, & Beam, 1999).
|
Baseline, 3-Months, 6-Months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline in Function at 3 and 6 months
Tidsramme: Baseline, 3-Months, 6-Months
|
The Functional Independence Measure (FIM) is an 18-item performance-based instrument which assesses the amount of assistance required to complete basic activities of daily living using a 7-point scale graded from 1 (dependent) to 7 (independent) (Jones & Feeny, 2006).
|
Baseline, 3-Months, 6-Months
|
|
Change from Baseline in Health Related Quality of Life at 3 and 6 months
Tidsramme: Baseline, 3-Months, 6-Months
|
The Health Utilities Index Mark 2 and 3 (HUI2/3) is a generic health related quality of life questionnaire based on two generic multi-attribute preference-based systems: the HUI2 and the HUI3.
The HUI2 assesses capacity on six dimensions (or attributes) of health status: sensation (vision, hearing, and speech), mobility, emotion, cognition, self-care, and pain.
The HUI3 consists of eight attributes: vision; hearing; speech; ambulation; dexterity; emotion; cognition; and, pain (Furlong, et al., 2011).
|
Baseline, 3-Months, 6-Months
|
|
Change from Baseline in Dementia Specific Quality of Life at 3 and 6 Months
Tidsramme: Baseline, 3-Months, 6-Months
|
The Quality of Life-Alzheimer's Disease (QofL-AD) was developed to capture the domains considered important to quality of life in Lawton's broad conceptual framework: the interpersonal; environmental; functional; physical; and, psychological domains.
The 13 items including physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores around the house, fun, money, life as a whole scored on a 4-point Likert scale ranging from 1 (poor) to 4 (excellent) (Lawton, 1983; 1991).
|
Baseline, 3-Months, 6-Months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Susan Slaughter, RN, PhD, University of Alberta
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Slaughter SE, Wagg AS, Jones CA, Schopflocher D, Ickert C, Bampton E, Jantz A, Milke D, Schalm C, Lycar C, Estabrooks CA. Mobility of Vulnerable Elders study: effect of the sit-to-stand activity on mobility, function, and quality of life. J Am Med Dir Assoc. 2015 Feb;16(2):138-43. doi: 10.1016/j.jamda.2014.07.020. Epub 2014 Sep 27.
- Slaughter SE, Estabrooks CA, Jones CA, Wagg AS. Mobility of Vulnerable Elders (MOVE): study protocol to evaluate the implementation and outcomes of a mobility intervention in long-term care facilities. BMC Geriatr. 2011 Dec 16;11:84. doi: 10.1186/1471-2318-11-84.
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
1. august 2011
Primær fullføring (Faktiske)
1. februar 2013
Studiet fullført (Faktiske)
1. juni 2013
Datoer for studieregistrering
Først innsendt
10. november 2011
Først innsendt som oppfylte QC-kriteriene
17. november 2011
Først lagt ut (Anslag)
18. november 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
26. januar 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. januar 2017
Sist bekreftet
1. juli 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DPA 108891
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .