Dementia Clinical Trial
— Solis MDCOfficial 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
Verified date | January 2017 |
Source | VU University of Amsterdam |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
VU University of Amsterdam | Zorggroep Solis |
Ballard C, O'Brien J, James I, Mynt P, Lana M, Potkins D, Reichelt K, Lee L, Swann A, Fossey J. Quality of life for people with dementia living in residential and nursing home care: the impact of performance on activities of daily living, behavioral and psychological symptoms, language skills, and psychotropic drugs. Int Psychogeriatr. 2001 Mar;13(1):93-106. — View Citation
Blankevoort CG, van Heuvelen MJ, Boersma F, Luning H, de Jong J, Scherder EJ. Review of effects of physical activity on strength, balance, mobility and ADL performance in elderly subjects with dementia. Dement Geriatr Cogn Disord. 2010;30(5):392-402. doi: 10.1159/000321357. Review. — View Citation
Burge E, Kuhne N, Berchtold A, Maupetit C, von Gunten A. Impact of physical activity on activity of daily living in moderate to severe dementia: a critical review. Eur Rev Aging Phys Act. 2012 Apr;9(1):27-39. — View Citation
Dechamps A, Diolez P, Thiaudière E, Tulon A, Onifade C, Vuong T, Helmer C, Bourdel-Marchasson I. Effects of exercise programs to prevent decline in health-related quality of life in highly deconditioned institutionalized elderly persons: a randomized controlled trial. Arch Intern Med. 2010 Jan 25;170(2):162-9. doi: 10.1001/archinternmed.2009.489. — View Citation
Edwards N, Gardiner M, Ritchie DM, Baldwin K, Sands L. Effect of exercise on negative affect in residents in special care units with moderate to severe dementia. Alzheimer Dis Assoc Disord. 2008 Oct-Dec;22(4):362-8. doi: 10.1097/WAD.0b013e31818ecbbc. — View Citation
Galik E, Resnick B, Hammersla M, Brightwater J. Optimizing function and physical activity among nursing home residents with dementia: testing the impact of function-focused care. Gerontologist. 2014 Dec;54(6):930-43. doi: 10.1093/geront/gnt108. — View Citation
Kemoun G, Thibaud M, Roumagne N, Carette P, Albinet C, Toussaint L, Paccalin M, Dugué B. Effects of a physical training programme on cognitive function and walking efficiency in elderly persons with dementia. Dement Geriatr Cogn Disord. 2010;29(2):109-14. doi: 10.1159/000272435. — View Citation
Morris JN, Fiatarone M, Kiely DK, Belleville-Taylor P, Murphy K, Littlehale S, Ooi WL, O'Neill E, Doyle N. Nursing rehabilitation and exercise strategies in the nursing home. J Gerontol A Biol Sci Med Sci. 1999 Oct;54(10):M494-500. — View Citation
Wetzels RB, Zuidema SU, de Jonghe JF, Verhey FR, Koopmans RT. Determinants of quality of life in nursing home residents with dementia. Dement Geriatr Cogn Disord. 2010;29(3):189-97. doi: 10.1159/000280437. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Degree of implementation of MDC at each ward measured with process evaluations. | 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 | 3, 6, 9 and 12 months of intervention. | |
Primary | Change from Baseline in Activities of Daily Living (ADL), measured with the Barthel Index. | 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. | baseline and 3, 6, 9 and 12 months after baseline assessment | |
Primary | Change from Baseline in Quality of Life (QoL), measured with the Qualidem | 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. | baseline and 3, 6, 9 and 12 months after baseline assessment | |
Secondary | Change from Baseline in general cognitive functions, measured with the Severe Impairment Battery 8 (SIB-8). | 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 | baseline and 3, 6, 9 and 12 months after baseline assessment. | |
Secondary | Change from Baseline in mood, measured with the Cornell Scale for Depression in Dementia (CSDD). | 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. | baseline and 3, 6, 9 and 12 months after baseline assessment | |
Secondary | Change from Baseline in behaviour, measured with the Apathy Evaluation Scale-10 (AES-10). | 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. | baseline and 3, 6, 9 and 12 months after baseline assessment. | |
Secondary | Change from Baseline in behaviour, measured with the Cohen-Mansfield Agitation Inventory (CMAI). | 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. | baseline and 3, 6, 9 and 12 months after baseline assessment. | |
Secondary | Change from Baseline in aerobic fitness, measured with the two minute walking test (2mWT). | 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. | baseline and 3, 6, 9 and 12 months after baseline assessment | |
Secondary | Change from Baseline in functional mobility and fall risk, measured with the Timed up and go (TUG). | 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. | baseline and 3, 6, 9 and 12 months after baseline assessment | |
Secondary | Change from Baseline in walking speed, measured with the ten meter timed walk. | 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. | baseline and 3, 6, 9 and 12 months after baseline assessment. |
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