|- candidate number||3178|
|- NTR Number||NTR1270|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-apr-2008|
|- Secondary IDs||08/083 MEC AMC|
|- Public Title||Case management in patients with Amyotrophic Lateral Sclerosis and their caregivers|
|- Scientific Title||The effectiveness of intensive case management in patients with Amyotrophic Lateral Sclerosis (ALS) and their caregivers|
|- ACRONYM||ALS-case management|
|- hypothesis||Case-management in ALS improves quality of life of ALS-patients and reduces the caregiver burden.|
|- Healt Condition(s) or Problem(s) studied||Amyotrophic Lateral Sclerosis (ALS), Quality of life, Case-management|
|- Inclusion criteria||1. Diagnosed as clinically definite, clinically probable, clinically probable lab-supported or clinically possible Amyotrophic Lateral Scelerosis according to the El Escorial criteria. |
2. Age > 18 years.
|- Exclusion criteria||1. Insufficient proficiency in the Dutch language. |
2. Cognitive impairment (diagnosed through the cognitive screening test: Mini Mental State Examination < 20).
3. Residence in a hospice/terminal care unit.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2008|
|- planned closingdate||1-nov-2010|
|- Target number of participants||195|
|- Interventions||For 1 year a case manager maintains contact with ALS patients and their informal caregiver through home visits, telephone calls and e-mail designed to provide information regarding symptoms, aids and adaptations and interventions, to control disease symptoms, and to coordinate care with the person's specialized ALS care teams.|
|- Primary outcome||Quality of life (ALSAQ-40)|
|- Secondary outcome||Patient: |
- ALS specific symptomatology (e.g. fatigue, stiffness/spasticity, pain, breathing difficulty, cramps, sialorrhia: ordinal scale score)
- Delivery time of aids and adaptations (recording time procedure request-delivery).
- Actualisation of a PEG catheter and a meeting at the CTB (recording of the duration of the procedure issue-actualisation).
- Restrictions in activities (ALSFRS-R)
- Restrictions in autonomy and participation (IPA)
- Caregiver burden (CSI).
Patient and caregiver:
- Quality of care (Quality of care questionnaire MITTZ)
- Depression and Anxiety (HADS)
|- Timepoints||baseline (T0)|
4 months (T1)
8 months (T2)
12 months (T3)
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Hanneke Creemers|
|- CONTACT for SCIENTIFIC QUERIES|| Hanneke Creemers|
|- Sponsor/Initiator ||Netherlands ALS Centre |
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Previous research has shown that the quality of care for patients with ALS is insufficient, especially the collaboration of the various disciplines, timely delivery of the necessary aids and adaptations, the high frequency of unsatisfactorily treated, but well treatable symptoms and that the caregiversí total burden is high. |
Case management appears to be the organisational solution. The case manager may provide a better symptom control since the coordinating and steering function leads to early interventions and early solutions to problems. In a randomized controlled trial the effectiveness of case management during 1 year on the quality of life of ALS-patients and the caregiver burden will be investigated.
|- Main changes (audit trail)|
|- RECORD||8-apr-2008 - 21-apr-2008|