Parkinson Netzwerk Ostsachsen - a prospective intervention study with embedded subgroup analysis for confirmatory comparison to matched control groups from West Saxony

Not Applicable

• Conditions: G20; Parkinson disease

• Registration Number: DRKS00024935
• Lead Sponsor: niversitätsklinikum Carl Gustav Carus DresdenKlinik und Poliklinik für Neurologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-01
• Results First Posted: 2022-03-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

PATIENTS:
- Existence of a written declaration of the informed consent after patient information
- In the case of patients who are unable to give their consent: a written declaration by the
informed consent of the legal representative after caregiver information
- Sufficient knowledge of the German language to complete the questionnaires
- Age = 18 years
- Diagnosis of Parkinson's disease by a specialist in neurology accordingly the criteria of the Movement Disorder Society, certainty of diagnosis probable ”, e.g. a maximum of two red flags ”and more supporting criteria than red flags ”.
- Transition phase or late phase of the disease, defined as at least one of the following criteria:
o Disturbing morning immobility or decrease in the drug effect at the end of the dose interval (anamnestic)
o Occurrence of hypermobility (clinical)
o Taking levodopa more than 4 times a day
o Unexplained pain
o Occurrence of hallucinations (at least once a month)
o Cognitive deficits (anamnestic or external anamnestic)
o More than one fall
- If there is no transition or late phase, one of the following criteria:
o Parkinson's tremor despite medication (clinical)
o Disturbing daytime sleepiness or sleep disturbances
o Impulse control disorder

CAREGIVERS:
- Relatives, supervisors or other main reference person in the study
included patients
- Existence of a written declaration of the informed consent after patient information
- Sufficient knowledge of German language to complete the questionnaires
- Age = 18 years
- One caregiver per study patient

Exclusion Criteria

PATIENTS:
The patient is incapable of giving consent AND does not have a family member with a proxy for health care or a legal representative

CAREGIVERS:
- Known cognitive impairment or other limitations that make participation in the study impossible (e.g. severely impaired hearing, and/or eyesight, and/or concentration or motor skills)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Parkinson's-specific quality of life<br><br>Assessment using the validated measuring instrument Parkinson's Disease Quality of Life (PDQ) -39 (baseline, after 6 and after 12 months)

Secondary Outcome Measures

Name	Time	Method
1. Gait disorder<br>Assessment with the Dresden Fall Frequency Questionnaire (DFQ)<br>2. Impulse control<br>Assessment with the Questionnaire for impulsive-compulsive behaviors in Parkinson's (QUIP-RS)<br>3. Depression<br>Assessment with Beck Depression Inventory (BDI II)<br>4. Psychoses<br>Assessment with the Neuropsychiatric Inventory Questionnaire (NPI-Q)<br>5. Subjectively perceived quality of care /satisfaction with the care process<br>Assessment with self-developed questionnaire on satisfaction with Parkinson's care<br>6. Degree of burden on caregivers<br>Assessment with the Parkinson's Disease Caregiver Burden (PDCB)