The primary objectives of the pilot study are: 1. To determine a successful strategy for recruiting and following-up participants during their transition phase from home to a nursing home; 2. To determine the suitability of the study procedure; 3.…
ID
Source
Brief title
Condition
- Other condition
- Lifestyle issues
Synonym
Health condition
Veroudering, dementie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Proportions of eligible, included, moved and dropped out participants
(quantitative endpoint); organizational barriers to recruitment (qualitative
endpoint);
2. a. The number of subsequent days needed to reliably assess physical activity;
b. Percentage and reason of data loss;
c. Interview with proxy / relative to assess feasibility for
themselves and participant;
3. Standard error of measurement (SEM), smallest detectable change (SDC) and
mimimal important change (MIC) of (life-space) mobility, physical activity
levels, and quality of life outcomes;
4. Means, average change and corresponding confidence intervals of the outcomes
are calculated to determine the study sample size of the
intended study.
Secondary outcome
The following outcome measures will be calculated from the Dutch translation of
the Life-Space Assessment
1. Content validity (the participants in this study will not be asked for this
purpose);
2. Construct validity (convergent and divergent) based on correlations with
other measured constructs collected during the pilot study;
3. SEM, SDC, MIC (see also point 3 for primary outcome measures).
Background summary
From cross-sectional studies it is known that the degree of physical activity
among nursing home residents suffering dementia is lower than among their
community-dwelling counterparts. It is still unknown when the changes in
physical activity occur: before the transition to the nursing home (as a
trigger) or after (as a consequence). It is also unclear to what extent the
living environment, the deterioration in health status or other personal
circumstances, and aspects of the transition procedure itself contribute to the
changes in physical activity before, during and after the transition into
nursing homes.
We aim to initiate a study to investigate the change in physical activity,
mobility and living environment during the transition from home to a nursing
home of older people who are about to move to a nursing home. Due to several
uncertain factors concerning recruitment and data collection, a pilot study
will first be conducted.
Study objective
The primary objectives of the pilot study are:
1. To determine a successful strategy for recruiting and following-up
participants during their transition phase from home to a nursing home;
2. To determine the suitability of the study procedure;
3. To select feasible and suitable measurement instruments for the intended
larger study;
4. To collect data for sample size calculation for the intended larger study.
Secondary objective is:
1. To collect data to validate the Dutch translation of the Life-Space
Assessment.
Study design
Observational pilot study.
Study burden and risks
There is no alternative setting available that is comparable to the transition
to a nursing home, which will be the residents' last station, making this study
group-related.
There are no direct benefits to participating in this study, but we intended to
minimize the burden on participants by selecting only outcomes with proven low
burden and high acceptance in people with dementia, all of relatively short
duration (15 minutes for the physical assessment in total per visit; followed
by wearing an accelerometer for the next 5 days); by involving family members /
informal care givers (to fill in questionnaires, respectively (20 minutes at a
time)); and by having all measurements/assessments taken at home. Risks in
participating in this study are considered negligible due to the observational
design. Indirect benefits can be the informal home visits in which time is
taken for the participant and his or her family member/carer and participants
can feel meaningful and heard.
Oostersingel 47
Groningen 9711 XC
NL
Oostersingel 47
Groningen 9711 XC
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed with any type of dementia and an indication for long-term care
- Community dwelling at the time of recruitment and inclusion;
- On the waiting list for nursing home placement or otherwise an expected
transfer to a nursing home within six months (Long-term care);
- Presence of a relative or informal carer who is willing to participate in the
study.
Exclusion criteria
- The subject has moved to a nursing (or residential care) home before the
first assessment;
- The subject moves to a nursing home with an temporary indication / other
indication than long-term care.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80341.042.22 |