Condition category
Nervous System Diseases
Date applied
22/11/2006
Date assigned
22/11/2006
Last edited
16/08/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

University Medical Center Groningen (UMCG) (Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20507600

Publication citations

  1. 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.

Additional files

Editorial Notes