To investigate the effectiveness of a psychological support program especially designed on the needs of ALS and PMA caregivers.
ID
Source
Brief title
Condition
- Family issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study outcome is the emotional functioning of the caregiver assessed
with the Hospital Anxiety and Depression Scale.
Secondary outcome
Secondary outcomes are the caregiver burden, caregiver quality of life, quality
of life of the patient and emotional functioning of the patient
Background summary
Caregivers are key figures in ALS and PMA care as patients become increasingly
dependent of their care during the disease course. ALS and PMA caregiving is an
intensive task and involves stressful demands. Caregivers* emotional
functioning deteriorates as the disease progresses. Improving the emotional
functioning of caregivers may not only improve the wellbeing of caregivers but
also the wellbeing of patients.
Study objective
To investigate the effectiveness of a psychological support program especially
designed on the needs of ALS and PMA caregivers.
Study design
We will investigate the effects of the psychosocial support program in a
randomized waitlist controlled trial. Caregiver-patient dyads will be asked to
fill in questionnaires on 4 occasions during the study: baseline, 3 months, 6
months and 9 months.
Intervention
The psychosocial support program consists of one face-to-face contact, 6 online
guided modules and one telephone contact directly after randomization. The
online program entails 6 modules based on Acceptance and Commitment therapy
with information, psychological exercises and meditation exercises aimed at
Mindfulness. Participants will receive weekly feedback from a psychologist. The
program offers the opportunity to get in contact with other informal ALS or PMA
caregivers.
Study burden and risks
During 9 months informal caregivers and patients will complete four online
assessments in total. The first assessment for the caregivers is more extensive
than the other three assessments. For caregivers the time investment for
completing the assessment ranges from 25-35 minutes for the first assessment to
20-30 minutes for the follow up assessments. Total time investment for
participating patients is limited to 20 minutes (fill in the four
questionnaires, which takes 5 minutes per questionnaire). To limit the burden
of the intervention for the caregivers, the face-to-face session will take
place at the participants* homes and the rest of the supportprogram is offered
online. Participants may benefit from the interventions. There are no known
risks for participating in this study.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
The research population consists of informal caregivers and the ALS and PMA patients they provide care for. In order to be eligible to participate in this study, caregiver-patient dyads must meet all of the following criteria:
* The caregiver is the partner of the ALS or PMA patient
* The informal caregiver is 18 years or older
* The informal caregiver and the patient have access to the Internet
* The patient gives the caregiver permission to answer questions which are related to the patient and the disease of the patient.
* The caregiver and the patient are able to complete Dutch questionnaires;When patients indicate they do not want to participate in the study, caregivers are allowed to participate without the patient. The inclusion criteria remain in force.
Exclusion criteria
* The caregiver participates in the ALS-CarE study
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 | NL56989.041.16 |