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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00018778 |
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Date of registration:
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05/12/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Development and evaluation of an IT-based Case Management to improve the care of patients with spinal muscular atrophy
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Scientific title:
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Development and evaluation of an IT-based Case Management to improve the care of patients with spinal muscular atrophy - SMA-C+ |
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Date of first enrolment:
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15/07/2019 |
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Target sample size:
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540 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00018778 |
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Study type:
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interventional |
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Study design:
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Allocation: Non-randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: health services research
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Thorsten
Langer |
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Address:
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Mathildenstr. 1
79106
Freiburg
Germany |
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Telephone:
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0761-27043000 |
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Email:
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thorsten.langer@uniklinik-freiburg.de |
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Affiliation:
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Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin, Klinik für Neuropädiatrie und Muskelerkrankungen |
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Name:
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Sabine
Wider |
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Address:
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Mathildenstr. 1
79106
Freiburg
Germany |
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Telephone:
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076127043440 |
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Email:
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sabine.wider@uniklinik-freiburg.de |
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Affiliation:
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Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin, Klinik für Neuropädiatrie und Muskelerkrankungen |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with SMA type 1 and heavily affected patients with SMA type 2 with their parents and treating physicians/therapist (sites in Freiburg and Essen only)
Exclusion criteria: Persons who don't meet the inclusion criteria
Age minimum:
0 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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G12.0
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Infantile spinal muscular atrophy, type I [Werdnig-Hoffman]
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Other inherited spinal muscular atrophy
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G12.0
G12.1
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G12.1
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Intervention(s)
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Group 1: Intervention group: n=20 families
The intervention consists of SMA-specific case management supported by an IT platform. The control group receives care at a muscle center without case management ("as usual"). The intervention period is 24 months. Survey times are the beginning of the intervention (t0), after 6 (t1), 12 (t2), 18 (t3) and 24 months (t4). Outcome measurement uses tools to measure health-related quality of life (SF36), parental burden (FaBel) and quality of care integration from a parental viewpoint (PICS-D).
Group 2: Control group: n=20 families
The intervention consists of SMA-specific case management supported by an IT platform. The control group receives care at a muscle center without case management ("as usual"). The intervention period is 24 months. Survey times are the beginning of the intervention (t0), after 6 (t1), 12 (t2), 18 (t3) and 24 months (t4). Outcome measurement uses tools to measure health-related quality of life (SF36), parental burden (FaBel) and quality of care integration from a parental viewpoint (PICS-D).
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Primary Outcome(s)
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Improvement of care integration and health related quality of life (parent's point of view)
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Secondary Outcome(s)
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Improvement of child health situation, parents sick leave and their health care utilisation
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Source(s) of Monetary Support
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DRL Projektträger, Bereich Gesundheit
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Ethics review
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Status: Approved
Approval date: 07/05/2019
Contact:
ekfr.mpg@uniklinik-freiburg.de
Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
+49-761-27072600
ekfr.mpg@uniklinik-freiburg.de
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