ISRCTN ISRCTN22635159
DOI https://doi.org/10.1186/ISRCTN22635159
Secondary identifying numbers NTR762; ABR NL13248.042.06
Submission date
22/11/2006
Registration date
22/11/2006
Last edited
16/08/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr C Annema
Scientific

University Medical Center Groningen
Department of Integrated Care
P3.264
P.O. Box 30001
Groningen
9700 RB
Netherlands

Phone +31 (0)50-3611490
Email j.h.annema@ccznn.umcg.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Scientific titleRandomised Controlled Trial on the effectiveness of a Dutch patient advocacy case management intervention among severely disabled Multiple Sclerosis patients
Study acronymCMMS
Study objectives1. 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(s)The Medical Ethics Review Board of the University Medical Center Groningen (ref: METc2006.140, ABR form NL13248.042.06).
Health condition(s) or problem(s) studiedMultiple sclerosis (MS)
InterventionPatients 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 typeOther
Primary outcome measureQuality of life
Secondary outcome measures1. Depression
2. Quaity of care
3. Care giver strain
4. Cost efficacy
Overall study start date10/08/2006
Completion date31/01/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants160
Key inclusion criteriaPeople 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
Key exclusion criteria1. Residents of nursing homes
2. Partipation in other research projects
Date of first enrolment10/08/2006
Date of final enrolment31/01/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Center Groningen
Groningen
9700 RB
Netherlands

Sponsor information

University Medical Center Groningen (UMCG) (Netherlands)
Hospital/treatment centre

Department of Neurology
P.O. Box 30001
Groningen
9700 RB
Netherlands

ROR logo "ROR" https://ror.org/03cv38k47

Funders

Funder type

Hospital/treatment centre

University Medical Center Groningen (Netherlands) - Internal funding

No information available

Icare (Netherlands) - an organisation for home care (cooperation partners)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 27/05/2010 Yes No