Contact information
Type
Scientific
Primary contact
Dr C Annema
ORCID ID
Contact details
University Medical Center Groningen
Department of Integrated Care
P3.264
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50-3611490
j.h.annema@ccznn.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR762; ABR NL13248.042.06
Study information
Scientific title
Randomised Controlled Trial on the effectiveness of a Dutch patient advocacy case management intervention among severely disabled Multiple Sclerosis patients
Acronym
CMMS
Study hypothesis
1. People with Multiple Sclerosis who receive care by a case manager experience a better quality of life and quality of care compared with people with MS who receive care as usual.
2. Caregivers of people with Multiple Sclerosis who receive care by a case manager experience a better quality of life compared with caregivers of people with MS who receive care as usual.
3. Healthcare cost for people with MS will increase during the first year in which they receive case management; in the long term costs will decrease.
Ethics approval
The Medical Ethics Review Board of the University Medical Center Groningen (ref: METc2006.140, ABR form NL13248.042.06).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Multiple sclerosis (MS)
Intervention
Patients will be randomised to
1. Case management: consisting of home visits twice a year by a Nurse practitioner or Nurse specialist MS. During the home visit the neurological examination is performed and the health status (physically, mentally and socially) of the person with MS is investigated as well as the impact of the disease on the lives of the person with MS and his/her caregiver.
Based on this investigation a care plan will be developed. Realisation of the goals set in the care plan is monitored by the case manager.
2. Control group: People with MS receive care as usual. They will visit their Neurologist at the outpatient clinic once or twice a year (or more if indicated).
Both groups consist of 50 persons with MS and 30 caregivers. The intervention will take place during 15 months.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Quality of life
Secondary outcome measures
1. Depression
2. Quaity of care
3. Care giver strain
4. Cost efficacy
Overall trial start date
10/08/2006
Overall trial end date
31/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
People with MS
1. Who have an Expanded Disability Status Scale (EDSS) score between 4.5 and 8.5
2. Treated in the University Medical Center of Groningen
Caregivers:
Partner with MS who is participating in the research directly involved in care fot the person with MS
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
160
Participant exclusion criteria
1. Residents of nursing homes
2. Partipation in other research projects
Recruitment start date
10/08/2006
Recruitment end date
31/01/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Groningen
Groningen
9700 RB
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
University Medical Center Groningen (Netherlands) - Internal funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Icare (Netherlands) - an organisation for home care (cooperation partners)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20507600
Publication citations
-
Protocol
Wynia K, Annema C, Nissen H, De Keyser J, Middel B, Design of a Randomised Controlled Trial (RCT) on the effectiveness of a Dutch patient advocacy case management intervention among severely disabled Multiple Sclerosis patients., BMC Health Serv Res, 2010, 10, 142, doi: 10.1186/1472-6963-10-142.