The current study aims to evaluate the effectiveness of an individual online self-management program called *Partner in Balans* in increasing feelings of self-confidence and preventing depressive complaints in family caregivers of patients with (…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
geen aandoeningen, zelfvertrouwen en psychische belasting/stress bij familieleden van mensen met dementie in een vroeg stadium (inclusief prodromale dementie; MCI due to AD)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The current study aims to evaluate the effectiveness of an individual online
self-management program called *Partner in Balans* in increasing feelings of
self-confidence and preventing depressive complaints in family caregivers of
patients with (very) early-stage dementia including prodromal dementia (MCI due
to AD according to the clinical criteria established by McKhann (McKhann,
Drachman et al. 1984; McKhann 2011).
The null-hypothesis states that there is no difference before and after
participating in the self-management intervention *Partner in Balans* and that
there is no difference between the intervention group and the waitlist-control
group in participant*s subjective well-being. The alternative hypothesis states
that there is a difference within and between groups after participating in the
self-management program. We expect the alternative hypothesis to be true, with
an improved subjective self-confidence (increased self-efficacy) and a
decreased or constant level of depressive complaints after participation in the
self-management intervention.
Secondary outcome
Our additional aim is to assess the feasibility of the online self-management
program *Partner in Balans* for the people receiving the intervention as well
as the people performing the intervention (the personal coaches) through a
process evaluation. Moreover, the costs of the intervention will be evaluated
by assessing the health care utilisation and associated costs in both groups
and the additional costs of 'Partner in Balans'.
Background summary
Due to the expected increase in the number of dementia patients, the
unlikelihood of a cure in the near future, and the rising cost of care, there
is a increasing need for effective caregiver interventions. Many psychosocial
interventions have been developed, but most currently available programs are
face-to-face and aiming at the moderate dementia stage. Internet interventions
based on self-management hold a considerable promise for meeting the
educational and support needs of caregivers at reduced costs.
Study objective
The current study aims to evaluate the effectiveness of an individual online
self-management program called *Partner in Balans* in increasing feelings of
self-confidence and preventing depressive complaints in family caregivers of
patients with (very) early-stage dementia including prodromal dementia (MCI due
to AD, based on the etiological diagnosis expected to convert to dementia)
Study design
This study involves a randomized waiting list controlled clinical trial. A
waiting list control group was chosen to give all potentially interested
participants the opportunity to take part in the intervention program.
Furthermore, usual care for early-stage dementia and prodromal dementia family
caregivers is often no or very low-frequent counselling, and the use of a no or
low-frequent treatment group may be unacceptable to participants (Campbell,
Fitzpatrick et al. 2000). Participants will be randomly assigned to receive
either the self-management intervention (n=40) or the waiting list control
group (n=40) after eligibility criteria are checked and after they signed the
informed consent. The self-management intervention *Partner in Balans* is an
(plus/minus, depending on own pace) 8-week program combining online modules
with face-to-face care. If usual care is being delivered to the control group
during the intervention period, the frequency and intensity will be closely
monitored and reported. For the intervention group, data will be collected pre-
and post-intervention and at 3, 6 and 12 months follow-up. For the
waitlist-control group, data will be collected pre- and post-waiting period,
post-intervention if applicable and at 3, 6 and 12-months follow-up.
Intervention
Participants will be asked to participate in an online self-management program
called *Partner in Balans* over an (+/-) 8-week period. In addition, they will
meet twice with a personal coach to assess goal attainment (see pages 15-16 and
appendix I of the research protocol). The online program will make use of a
self-management approach, aimed at learning skills and taking the personal
needs of the caregivers as starting point. Online self-management programs have
already been used to support patients and caregivers and show promising
results. The Stress and Coping model by Lazarus and Folkman (1984) and the
Social Learning theory by Bandura (1977) also served as the theoretical
framework for the development and evaluation of the program. In addition, the
program was based on the knowledge and experience of the target group (by means
of focus group interviews) and professionals (individual interviews) who deal
with MCI/dementia caregivers on a daily basis.
Study burden and risks
To our knowledge, there are no major risks associated with participating in the
online self-management program. We don*t expect the content of the modules to
be too confronting or emotionally stressful to cause any psychological harm to
the participants, because participants can choose the modules of their own
preference and the content of the modules is based on the needs of the target
population and the knowledge of dementia care professionals. However, we
acknowledge that participating in the online self-management program can be
time-consuming and demanding for participants. One way to reduce the burdensome
nature of the program is to reduce the number of modules to a minimum of 4 in 8
weeks (1 module per 2 weeks). Previous research by Daniels suggested that
self-management requires a different amount of time for each individual,
therefore participants can divide the +/- 8-week time period (depending on
their own pace) over 4 modules.
Participating in the study has an additional advantage to participants, since
the online self-management program is aimed at strengthening participants by
increasing their feelings of self-efficacy and mastery and preventing them from
becoming overburdened.
Dr. Tanslaan 12
Maastricht 6229 ET
NL
Dr. Tanslaan 12
Maastricht 6229 ET
NL
Listed location countries
Age
Inclusion criteria
- Family caregiver of a patient diagnosed with (very) early-stage dementia including prodromal dementia (MCI due to AD, based on the etiological diagnosis expected to convert to dementia).
- Caregiver is >18 years.
- Caregiver has access to the Internet at home and already masters basic skills in the use of computers.
- Written informed consent is obtained.
Exclusion criteria
- Caregivers who have insufficient cognitive abilities to engage in the online self-management program (based on clinical judgment of knowledgeable practitioner, based on his/her experience with the target group).
- Caregivers who are overburdened or have severe health problems (based on clinical judgment of knowledgeable practitioner, based on his/her experience with the target group).
- Caregivers who*s current or near-future situation demands acute, intensive counselling (based on clinical judgment of knowledgeable practitioner, based on his/her experience with the target group).
- Caregivers of people with dementia caused by human immunodeficiency virus (HIV), acquired brain impairment, Down syndrome, chorea of Huntington or alcohol abuse.
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 | NL48760.068.14 |
| Other | TC = 4748 |
| OMON | NL-OMON24958 |