A nurse-led intervention to reduce dopamine dysregulation syndrome in Parkinson's disease patients and their carers

Not Applicable

Completed

Conditions: Parkinson's disease
Nervous System Diseases

Registration Number: ISRCTN82636004

Lead Sponsor: King's College London (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

1. Patients and caregiver dyads, male and female aged 18 years and older
2. Participants must have clinical diagnosis of Parkinson's disease
3. Participants must be suspected of having dopamine dysregulation syndrome or impulse control disorders
4. Both members of the dyad must be able to consent to the study

Exclusion Criteria

1. Participant cannot speak English
2. Participant has a Mini Mental State Examimation (MMSE) Score of less than 19
3. Participant does not have an identifiable carer

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessments will take place at randomisation (week 0), at 12 - 16 weeks (end of treatment for the treatment group) and 24 weeks. <br><br>Caregiver:<br>1. The Zarit Carer Burden scale<br>2. The General Health Questionnaire (GHQ-12)<br>3. The Neuropsychiatric Inventory (given at 0 and repeated at 24 weeks)<br> <br>Patients:<br>Individualised and standard scales to rate the frequency/severity/impact of the problem behaviour (e.g., Voon scales for gambling/hypersexuality). These will be recorded during the course of the trial as an aid to the individual intervention and to serve as a target for change (pre-treatment versus end of treatment scores).

Secondary Outcome Measures

Name	Time	Method
Assessments will take place at randomisation (week 0), at 12 - 16 weeks (end of treatment for the treatment group) and 24 weeks. <br><br>1. Neuropsychiatric Inventory symptoms-cluster scores<br>2. The Golombok Rust Inventory Marital Status<br>3. Changes in medication, added psychotropic drugs and resource use (e.g. emergency doctor services; hospital admission)<br><br>It will not be feasible to rate outcome blind to treatment allocation since any carer interview is bound to reveal this. Observer bias will be minimised by the use of self-report measures.