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ALS caregivers


- candidate number24153
- NTR NumberNTR5734
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-mrt-2016
- Secondary IDs16/273 METC UMC Utrecht
- Public TitleALS caregivers
- Scientific TitleALS caregivers are keyfigures in ALS care: Take care of them!
- ACRONYM
- hypothesisA psychological supportprogram based on Acceptance and Commitment Therapy improves the emotional functioning of caregivers of people with Amyotrophic Lateral Sclerosis(ALS).
- Healt Condition(s) or Problem(s) studiedAmyotrophic Lateral Sclerosis (ALS), Informal care-givers, Emotions
- Inclusion criteriaIn order to be eligible to participate in this study, caregiver-patient dyads must meet all of the following criteria:
1. The informal caregiver is the partner of an ALS patient
2. The informal caregiver is 18 years or older
3. The informal caregiver and the patient have access to the Internet
- Exclusion criteriaCaregiver-patient dyads who meet any of the following criteria will be excluded from participation in this study:
1. The caregiver or patient is unable to complete questionnaires due to insufficient mastery of the Dutch language
2. The caregiver is diagnosed with a severe psychiatric disorder or physical disorder
3. The patient is diagnosed less than 3 months ago
4. The patient has a life expectancy of less than six months
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 16-jun-2016
- planned closingdate16-jun-2018
- Target number of participants140
- InterventionsA psychological supportprogram based on Acceptance and Commitment Therapy.
- Primary outcomeThe emotional functioning of the caregiver measured with the Hospital Anxiety and Depression Scale (HADS).
- Secondary outcomeSecondary outcomes are the feelings of caregiver burden (Zarit Burden Scale) and quality of life of the caregiver (Care Related- Quality of Life) and the quality of life (McGill Quality of Life Questionnaire- Single Item Scale) and emotional functioning of the patient (Hospital Anxiety and Depression Scale).
- TimepointsBaseline, 3 months and 6 months after baseline.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Jessica de Wit
- CONTACT for SCIENTIFIC QUERIES Jessica de Wit
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Stichting ALS Nederland
- Publications
- Brief summaryCaregivers are key figures in ALS care as patients become increasingly dependent of their care during the disease course. ALS caregiving is an intensive task and involves stressful demands. Caregiversí 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. In this study we will investigate the effects of a psychosocial support program based on Acceptance and Commitment Therapy in a randomized waitlist controlled trial. Caregiver-patient dyads will be asked to fill in questionnaires on 3 occasions during the study: baseline, 3 months and 6 months. The main study outcome is the emotional functioning of the caregiver assessed with the Hospital Anxiety and Depression Scale. Secondary outcomes are the caregiver burden, caregiver quality of life, quality of life of the patient and emotional functioning of the patient. Group differences in primary and secondary outcomes will be compared with lineair mixed model analysis.
- Main changes (audit trail)
- RECORD28-mrt-2016 - 22-mei-2016


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