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Trial record 6 of 3200 for:    Dementia

The Effect of Movement-oriented Dementia Care on ADL and QoL of Dementia Patients in Nursing Homes (Solis MDC)

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ClinicalTrials.gov Identifier: NCT03001232
Recruitment Status : Completed
First Posted : December 22, 2016
Last Update Posted : February 3, 2017
Sponsor:
Collaborator:
Zorggroep Solis
Information provided by (Responsible Party):
Marinda Henskens, VU University of Amsterdam

Brief Summary:

The purpose of this study is to determine whether movement-oriented dementia care has a positive effect on quality of life and independence in activities of daily living (ADL) in nursing-home residents with dementia.

It was hypothesized that movement-oriented dementia care has a positive effect on quality of life and independence in ADL, as well as on mood, behavior, cognition and physical functioning, in comparison to regular care.


Condition or disease Intervention/treatment Phase
Dementia Behavioral: Movement-oriented Dementia Care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Enriched Environment and Dementia: The Effect of an Individual Daily Calendar on the Activity Level and Mental Functions of Persons With Dementia in a Nursing Home
Study Start Date : March 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Movement-oriented Dementia Care
The experimental group received movement-oriented dementia care for a period of twelve months.Movement-oriented dementia care is a multidisciplinary approach in which all involved disciplines focus on stimulating physical activity and independence as much as possible. This way physical activity is stimulated at all times for the participants.
Behavioral: Movement-oriented Dementia Care
The intervention is a new multidisciplinary approach that focuses on optimizing physical activity and independence in daily care and activities. MDC intended to incorporate all persons surrounding the patients. The nursing staff was intensively trained by an expert in MDC, and played a central role in continuously stimulating patients to function as independently as possible. Geriatric physicians and physiotherapists advised the nursing staff about participants' medical and physical limitations to ensure safe stimulation. Consequently, a plan was created for each resident to determine the daily routines they were capable of performing themselves. Caregivers and volunteers were informed about the benefits of an active lifestyle during several open meetings.

No Intervention: Care as usual
The control group received care as usual



Primary Outcome Measures :
  1. Change from Baseline in Activities of Daily Living (ADL), measured with the Barthel Index. [ Time Frame: baseline and 3, 6, 9 and 12 months after baseline assessment ]
    The Barthel Index is a survey consisting of 10 performance items (e.g. toilet use, dressing) rated on an ordinal scale (two-point, three-point or four-point scale), indicating the level of help needed. Scores range from 0 to 20, with higher scores representing a higher level of functional independence.

  2. Change from Baseline in Quality of Life (QoL), measured with the Qualidem [ Time Frame: baseline and 3, 6, 9 and 12 months after baseline assessment ]
    The Qualidem is a questionnaire with 40 items of observable behaviour rated on a four-point rating scale, ranging from 1 (never) to 4 (often). There is no total score; scores can only be obtained for the nine subscales. For each subscale, a higher score represented a better quality of life.


Secondary Outcome Measures :
  1. Change from Baseline in general cognitive functions, measured with the Severe Impairment Battery 8 (SIB-8). [ Time Frame: baseline and 3, 6, 9 and 12 months after baseline assessment. ]
    The SIB-8 consists of eight questions measuring orientation in time, writing, fluency, naming, and attention. Scores range from 0 to 16, with higher scores indicating better cognitive functions

  2. Change from Baseline in mood, measured with the Cornell Scale for Depression in Dementia (CSDD). [ Time Frame: baseline and 3, 6, 9 and 12 months after baseline assessment ]
    The CSDD consists of 30 questions rated on a two-point scale ranging from 0 (absent) to 2 (severe). Scores range from 0 to 38, with higher scores representing a higher level of depressive symptoms.

  3. Change from Baseline in behaviour, measured with the Apathy Evaluation Scale-10 (AES-10). [ Time Frame: baseline and 3, 6, 9 and 12 months after baseline assessment. ]
    The AES-10 is a selection of 10 items from the original AES, which were applicable to nursing home residents. The items represent behaviours (contra) indicative for apathy (e.g. being motivated). Each item is rated on a four-point scale, ranging from 1 (not characteristic) to 4 (very characteristic). Scores range from 10 to 40, which higher scores representing more apathetic behaviour.

  4. Change from Baseline in behaviour, measured with the Cohen-Mansfield Agitation Inventory (CMAI). [ Time Frame: baseline and 3, 6, 9 and 12 months after baseline assessment. ]
    The CMAI is a questionnaire consisting of 29 items representing types of agitated behaviour, rated on a seven-point scale. Higher scores indicate more agitated behaviour.

  5. Change from Baseline in aerobic fitness, measured with the two minute walking test (2mWT). [ Time Frame: baseline and 3, 6, 9 and 12 months after baseline assessment ]
    The participant was requested to walk the largest distance possible during a time period of two minutes. The participant was allowed to use a walking device and take breaks if necessary.

  6. Change from Baseline in functional mobility and fall risk, measured with the Timed up and go (TUG). [ Time Frame: baseline and 3, 6, 9 and 12 months after baseline assessment ]
    The participant was asked to stand up from a chair with armrests, walk three metres, turn around, walk back to the chair, and sit down again. The participant was allowed to use a walking device. The time it took for the participant to perform these steps was recorded by the examiner.

  7. Change from Baseline in walking speed, measured with the ten meter timed walk. [ Time Frame: baseline and 3, 6, 9 and 12 months after baseline assessment. ]
    The participant was asked to walk 10 meters in a comfortable speed. The participant was allowed to use a walking device. The test was repeated three times, where the fastest attempt was used as an outcome measure for walking speed as recorded in metres per second.


Other Outcome Measures:
  1. Degree of implementation of MDC at each ward measured with process evaluations. [ Time Frame: 3, 6, 9 and 12 months of intervention. ]
    Process evaluations included both questionnaires and structured interviews. Questionnaires were completed by the nursing staff and family caregivers. Structured interviews were conducted with members of a multidisciplinary focus group



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of dementia (based on medical charts)
  • Living in a psychogeriatric ward of Solis for at least three weeks
  • 65 years of age or older

Exclusion Criteria:

  • Very bad vision
  • Psychotic symptoms
  • A palliative care protocol
  • A score on the Mini-Mental State Examination (MMSE) of 25 or higher

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03001232


Sponsors and Collaborators
VU University of Amsterdam
Zorggroep Solis
Investigators
Principal Investigator: Marinda Henskens, Msc VU University of Amsterdam
Principal Investigator: Erik JA Scherder, Prof. Dr. VU University of Amsterdam
Study Director: Susan Vrijkotte, Msc Zorggroep Solis

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marinda Henskens, Msc, VU University of Amsterdam
ClinicalTrials.gov Identifier: NCT03001232     History of Changes
Other Study ID Numbers: METc Vumc: 2013.311/A2015.245
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Marinda Henskens, VU University of Amsterdam:
Movement-oriented Dementia Care
QoL
ADL
Nursing Home

Additional relevant MeSH terms:
Dementia
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases