This study aims to assess the acceptability and usability of the ECH system from the perspective of patients, their informal carers and their clinicians in a routine outpatient setting for patients with recurrent depressive or bipolar disorder. A…
ID
Source
Brief title
Condition
- Other condition
- Mood disorders and disturbances NEC
Synonym
Health condition
recidiverende depressieve of bipolaire stoornis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures include acceptability (for patients), usability (for
patients, their informal carers and clinicians) and client satisfaction (for
patients).
Secondary outcome
Secondary outcome measures will focus on mood disorder symptom severity, sleep
and activity and the correlation with the self-report variables of the HomePad
(mood, sleep and activity).
Background summary
Studies show that depression has an unfavourable prognosis in late life, with a
higher risk of relapse and chronicity than in younger populations. Bipolar
disorder, though less common, accounts for 8-10% of psychiatric admissions in
late life. Elderly patients with these disorders face a number of challenges
posed by mental and physical ageing and often a decrease in social interaction
and network. The eCare@Home (ECH) project aims to optimize long-term
face-to-face treatment for these patients using a user-friendly tablet
computer. The system facilitates self-management and relapse prevention, as
well as contact with the patient's family, friends and clinician.
Study objective
This study aims to assess the acceptability and usability of the ECH system
from the perspective of patients, their informal carers and their clinicians in
a routine outpatient setting for patients with recurrent depressive or bipolar
disorder. A secondary objective is to obtain an indication of the relation
between the self-report scales of the ECH system and changes in depressive
symptoms, manic symptoms, activity and sleep. Good feasibility (i.e. adequate
system acceptability and usability) will justify and inform a subsequent formal
clinical trial of ECH.
Study design
This is a single-group feasibility study with a pre-post design.
Intervention
The ECH system is based on a generic ICT platform for support for older adults,
their friends and family, and their clinicians. Before and during the
developmental process, patients, their clinicians and informal carers were
interviewed about what they would want and expect from the ECH system. These
user assessments resulted in a focus on three main tasks: support for
monitoring their mood, activity and sleep; support for staying in touch with
their family, friends and clinicians; and keeping up with information about
their disorder, medication and relapse prevention plan. There will be separate
internet portals for the patients' clinicians, informal carers and friends and
family.
Study burden and risks
Because participating patients continue their regular treatment, participation
in this study entails a negligible additional risk. Potential risks could
involve security problems of the ECH server and technical problems, but both
are minimized by adhering to common security standards, using professional
hosts, and extensive pre-trial alpha testing of the platform. A burden could be
filling in questions about mental health issues, although filling in such
questions is part of the regular treatment as well.
AJ Ernststraat 1187
Amsterdam 1081 HL
NL
AJ Ernststraat 1187
Amsterdam 1081 HL
NL
Listed location countries
Age
Inclusion criteria
Patients who are eligible:
- are 60 years of age or older;
- are currently treated by GGZ inGeest for recurrent depression (minimally two former depressive episodes including the present episode) or bipolar disorder (as determined by the GGZ inGeest registration records);
- have been in treatment at GGZ inGeest for at least 6 months;
- have sufficient command of the Dutch language, both verbally and in writing;
- provide signed informed consent.
Informal carers who are eligible:
- live together with the patient (e.g. as a spouse) or have contact with the patient at least once a week;
- are 18 years of age or older;
- sign the informed consent form as well.
Exclusion criteria
There are no exclusion criteria.
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 | NL50436.029.14 |
| OMON | NL-OMON21312 |