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Mobility of Vulnerable Elders (MOVE): Translating Knowledge to Health Care Aides in Long-term Care Facilities (MOVE)

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ClinicalTrials.gov Identifier: NCT01474616
Recruitment Status : Completed
First Posted : November 18, 2011
Last Update Posted : January 26, 2017
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
CapitalCare Continuing Care
Extendicare
Good Samaritan Society
Shepherd's Care Foundation
Information provided by (Responsible Party):
University of Alberta

Tracking Information
First Submitted Date  ICMJE November 10, 2011
First Posted Date  ICMJE November 18, 2011
Last Update Posted Date January 26, 2017
Study Start Date  ICMJE August 2011
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
Change from Baseline in Mobility at 3 and 6 months [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2011)
Change from Baseline in Mobility at 3 and 6 months [ Time Frame: 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 transfering (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).
Change History Complete list of historical versions of study NCT01474616 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2011)
  • Change from Baseline in Function at 3 and 6 months [ Time Frame: 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).
  • Change from Baseline in Health Related Quality of Life at 3 and 6 months [ Time Frame: 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).
  • Change from Baseline in Dementia Specific Quality of Life at 3 and 6 Months [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mobility of Vulnerable Elders (MOVE): Translating Knowledge to Health Care Aides in Long-term Care Facilities
Official Title  ICMJE Mobility of Vulnerable Elders (MOVE): Translating Knowledge to Health Care Aides in Long-term Care Facilities
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Mobility Limitation
Intervention  ICMJE Other: 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.
Study Arms  ICMJE Sit-to-Stand Activity
Intervention: Other: Sit-to-Stand Activity
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2013)
113
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2011)
120
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01474616
Other Study ID Numbers  ICMJE DPA 108891
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • CapitalCare Continuing Care
  • Extendicare
  • Good Samaritan Society
  • Shepherd's Care Foundation
Investigators  ICMJE
Principal Investigator: Susan Slaughter, RN, PhD University of Alberta
PRS Account University of Alberta
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP