- Our primary objective is to evaluate the feasibility and validity of using the ESM, specifically implemented in the smartphone application called PsyMate, in an MCI population.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
People with Mild Cognitive Impairment (MCI) (and their relevant others)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Feasibility will be assessed by examining compliance with the PsyMate as well
as through subjective participants* ratings of the difficulty, time burden and
overall acceptability of the methodology.
- Validity of the ESM in people with MCI: (1) internal validity will be
determined in the context of person with MCI by examining the presence of
expected patterns among variables in daily life of the participant using the
ESM (e.g., associations between daily stressors and mood states) and (2)
ecological validity by examining the concordance between ESM measurements and
standard retrospective measurements of the same construct e.g. 'mood' through
12 ESM items and retrospective measures.
Secondary outcome
/
Background summary
Individuals diagnosed with mild cognitive impairment (MCI) experience a decline
in at least one cognitive domain while their functional abilities are mostly
preserved. Studies reveal, however, that complex task can be difficult to
handle for people with MCI. Additionally, they have an increased risk for
psychological symptoms such as anxiety and depression, potentially further
complicating the management of everyday life. Research investigating on
emotions, behavior and cognition in people with MCI uses normally retrospective
measures. This is particularly questionable in a population with potential
difficulties to recall past information. Ecologically valid information on how
people with MCI perceive and react to challenges on a daily basis is lacking.
The Experience Sampling Methodology (ESM) is an innovative technique that is
specifically appropriate to collect individual information in everyday life.
ESM can reveal pattern of activities and context, related emotions as well as
their fluctuations in daily lives. This real-time information may give the
individual, the caregiver, clinician as well as research insight into the
condition and could contribute to a better self-management. To our knowledge,
ESM has not been used in MCI yet.
Study objective
- Our primary objective is to evaluate the feasibility and validity of using
the ESM, specifically implemented in the smartphone application called PsyMate,
in an MCI population.
Study design
The study involves a feasibility study in which thirty people with MCI will be
included. Furthermore thirty relevant other of the person with MCI will be ask
to provide additional information.
Study burden and risks
To our knowledge, there are no major risks associated with the use of the
PsyMate application. We do not expect the ESM questions to be too confronting
or emotionally stressful to cause any psychological harm to the participants,
because the questions concern the daily activities of the person with MCI,
which should be mainly preserved according to diagnostic criteria. However, we
acknowledge that the ESM can be time-consuming and demanding for participants.
We took this into account by limiting the number of ESM questions to a number
that is acceptable according to the literature.
Dr Tanslaan 12
Maastricht 6229 ET
NL
Dr Tanslaan 12
Maastricht 6229 ET
NL
Listed location countries
Age
Inclusion criteria
Person with MCI:
- Having a clinical diagnosis of MCI, according to Petersen (2004) criteria.
- In possession of a smartphone with an operation system from android or iOS.
- Written informed consent is obtained from the person with MCI., Relevant
other:
-Written informed consent is obtained from the relevant other of the person
with MCI
Exclusion criteria
- Subjects with MCI who have insufficient cognitive abilities to engage with
the PsyMate application (based on clinical judgment).
- Subjects with MCI who have severe health problems (based on clinical
judgment) such as a diagnosis of somatic, psychiatric or neurological disorder
potentially causing cognitive dysfunction.
- If the person with MCI or the relevant other does not wish to take part,
study participation is not permitted.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL64310.068.17 |
| Other | NTR (TC = 6918) |
| OMON | NL-OMON24090 |