Case Management for people with Multiple Sclerosis
| ISRCTN | ISRCTN22635159 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22635159 |
| Protocol serial number | NTR762; ABR NL13248.042.06 |
| Sponsor | University Medical Center Groningen (UMCG) (Netherlands) |
| Funders | University Medical Center Groningen (Netherlands) - Internal funding, Icare (Netherlands) - an organisation for home care (cooperation partners) |
- 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
Scientific
University Medical Center Groningen
Department of Integrated Care
P3.264
P.O. Box 30001
Groningen
9700 RB
Netherlands
| Phone | +31 (0)50-3611490 |
|---|---|
| j.h.annema@ccznn.umcg.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Randomised Controlled Trial on the effectiveness of a Dutch patient advocacy case management intervention among severely disabled Multiple Sclerosis patients |
| Study acronym | CMMS |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
Quality of life |
| Key secondary outcome measure(s) |
1. Depression |
| Completion date | 31/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 160 |
| Key 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 |
| Key exclusion criteria | 1. Residents of nursing homes 2. Partipation in other research projects |
| Date of first enrolment | 10/08/2006 |
| Date of final enrolment | 31/01/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Groningen
Groningen
9700 RB
Netherlands
9700 RB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
