Condition category
Nervous System Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
17/09/2012
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 Michael Barnes

ORCID ID

Contact details

Newcastle City Health NHS Trust
Hunters Moor Rehabilitation Centre
Hunters Road
Newcastle upon Tyne
NE2 4NR
United Kingdom
+44 (0)191 261 0895
m.p.barnes@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NYRHA WJML r135/05292

Study information

Scientific title

Acronym

Study hypothesis

A properly trained outreach nurse practitioner can provide a service that is as good as or better than that provided at a hospital outpatient clinic for people with chronic neurological disability.
The pilot population that is to be used to test this hypothesis is individuals with Parkinson's disease and dystonia attending Hunters Moor Regional Rehabilitation Centre in Newcastle upon Tyne. All patients attending the movement disorder clinic at Hunters Moor will be eligible for participation in the study.
We anticipate the hypothesis will be proven and that a properly trained nurse practitioner is able to provide a more satisfactory support service for people with the pilot condition both from the patients and general practitioners perspectives. If the hypothesis is proven the project will benefit the NHS as the patient will not need to make unnecessary journeys to hospital, the primary care team will be involved more effectively in the management of the individual, the specialist will see individuals at the time when such referral is required and the purchaser should get better value for money.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Parkinson's disease

Intervention

After informed consent patients will be randomly divided into two groups with approximately 75 individuals in each group.

1. Standard attendance of outpatients
This group will continue to attend regular outpatient assessment at Hunters Moor as previously.

2. Visited at home by an outreach nurse practitioner
This group will not attend outpatients but will be visited at home by an outreach nurse practitioner. The group will have regular access to the nurse practitioner who will act a primary contact point for the disabled person and the family. The nurse practitioner will be responsible for liaison with the general practitioner and primary care team and for referral to the hospital consultant and members of the multi-disciplinary rehabilitation team as necessary. The consultant and multi-disciplinary team members will be able to assess the client and carer either at home or in the hospital. The nurse practitioner, within agreed protocols, would advise the patient on adjusting drug dosages and be responsible for the administration of botulinum toxin injections for individuals with dystonia.
The practitioner will provide educational material, advice and ongoing support for the patient and carer.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The effectiveness of this model of care will be assessed by a number of means including
1. Assessment of disability status measured by a number of appropriate scales
1.1. general practitioner and primary care team satisfaction questionnaires
1.2. comparison of attendances at hospital and general practitioner
1.3. record of complications
1.4. record of drug and other medical management employed during the study period
2. Satisfaction questionnaires will be administered to the patient and carer and their psychological status will also be measured using the General Health Questionnaire.
3. A brief questionnaire will be designed that records the extent and level of knowledge and understanding of the disease and associated disabilities. This questionnaire will be administered to the client and carer.
4. An economic analysis will also be undertaken of the costs involved in both arms of the study.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

08/01/1995

Overall trial end date

31/07/1997

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients attending the movement disorder clinic at Hunters Moor
2. Being treated for Parkinson's and dystonia
3. Informed consent

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

08/01/1995

Recruitment end date

31/07/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newcastle City Health NHS Trust
Newcastle upon Tyne
NE2 4NR
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (UK)

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

1. 2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11295008

Publication citations

  1. Results

    Whitaker J, Butler A, Semlyen JK, Barnes MP, Botulinum toxin for people with dystonia treated by an outreach nurse practitioner: a comparative study between a home and a clinic treatment service., Arch Phys Med Rehabil, 2001, 82, 4, 480-484, doi: 10.1053/apmr.2001.21843.

Additional files

Editorial Notes