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

Development and evaluation of a nurse-led intervention to reduce behavioural complications of dopamine dysregulation syndrome for Parkinson's patients and their caregivers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN82636004

Enrollment

Registered

2008-09-18

Start date

2009-01-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease Nervous System Diseases Parkinson's disease

Interventions

The trial will be a psychosocial intervention versus waiting list controls. The intervention will be a psychosocial intervention and will consist of six planned, fortnightly sessions. The sessions wi

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Assessments will take place at randomisation (week 0), at 12 - 16 weeks (end of treatment for the treatment group) and 24 weeks. Caregiver: 1. The Zarit Carer Burden scale 2. The General Health Questionnaire (GHQ-12) 3. The Neuropsychiatric Inventory (given at 0 and repeated at 24 weeks) Patients: 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).	—

Measure

Time frame

Assessments will take place at randomisation (week 0), at 12 - 16 weeks (end of treatment for the treatment group) and 24 weeks. Caregiver: 1. The Zarit Carer Burden scale 2. The General Health Questionnaire (GHQ-12) 3. The Neuropsychiatric Inventory (given at 0 and repeated at 24 weeks) Patients: 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).

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Secondary

Measure	Time frame
Assessments will take place at randomisation (week 0), at 12 - 16 weeks (end of treatment for the treatment group) and 24 weeks. 1. Neuropsychiatric Inventory symptoms-cluster scores 2. The Golombok Rust Inventory Marital Status 3. Changes in medication, added psychotropic drugs and resource use (e.g. emergency doctor services; hospital admission) 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.	—

Measure

Time frame

Assessments will take place at randomisation (week 0), at 12 - 16 weeks (end of treatment for the treatment group) and 24 weeks. 1. Neuropsychiatric Inventory symptoms-cluster scores 2. The Golombok Rust Inventory Marital Status 3. Changes in medication, added psychotropic drugs and resource use (e.g. emergency doctor services; hospital admission) 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.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026