Is Carer Assisted Adherence Therapy beneficial for improving medication adherence and quality of life in people with PARKinson's disease?

Not Applicable

Completed

• Conditions: Medication adherence in people with Parkinson's disease; Nervous System Diseases; Parkinson's disease

• Registration Number: ISRCTN07830951
• Lead Sponsor: niversity of East Angia (UK)

Brief Summary

1. 2011 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/22122912 2. 2014 results in https://www.ncbi.nlm.nih.gov/pubmed/24750544

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-21
• Study Completion: 2012-10-31
• Last Update Posted: 5 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Current inclusion criteria as of 20/12/2011
1. Adults diagnosed with, or with probable, Idiopathic PD (three out of four of the chief UK Brain Bank criteria)
2. Prescribed one or more anti-parkinsonian medications by a Consultant Neurologist or Consultant Physician with specialist knowledge of movement disorders
3. English speaking and literate (participants are required to actively engage in the therapy process)
4. Stable medication regime i.e. not altered within the previous month, and not expected to change during the period of the research project (12 weeks)
5. Not demented or significantly cognitively impaired as assessed either informally by the clinical team or formally using the Mini-Mental State Examination (MMSE) score of = 24 (recent clinic score used where available)
6. Show poor adherence as determined by a Morisky Medication Adherence Scale (MMAS-4) score of 1 or above

Previous inclusion criteria
1. Adults diagnosed with, or with probable, Idiopathic PD (three out of four of the chief UK Brain Bank criteria)
2. Prescribed one or more anti-parkinsonian medications by a Consultant Neurologist or Consultant Physician with specialist knowledge of movement disorders
3. English speaking and literate (participants are required to actively engage in the therapy process)
4. Stable medication regime i.e. not altered within the previous month, and not expected to change during the period of the research project (12 weeks)
5. Not demented or significantly cognitively impaired as assessed either informally by the clinical team or formally using the Mini-Mental State Examination (MMSE) score of = 24 (recent clinic score used where available)
6. Show poor adherence as determined by a Morisky Medication Adherence Scale (MMAS-4) score = 2

Exclusion Criteria

1. Suspected Parkinsonism due to other causes than idiopathic PD
2. Treated with anti-parkinsonian medications for a mental health complaint
3. Diagnosed with dementia
4. Life expectancy < 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in adherence to medication determined by the Morisky Medication Adherence Scale (MMAS-4) <br>2. Change in quality of life (QoL) determined by the Parkinson?s Disease Questionnaire-39 (PDQ-39)

Secondary Outcome Measures

Name	Time	Method
People with PD:<br>1. Movement Disorder Society Unified Parkinson?s Disease Rating Scale (MDS-UPDRS) Part I (non-motor experiences of daily living), Part II (motor experiences of daily living) and Part IV (motor complications)<br>2. Beliefs about Medication Questionnaire (BMQ)<br>3. EuroQol quality of life questionnaire (EQ-5D)<br><br>Spouse/Carer Outcomes:<br>1. Carer Distress Scale (CDS) <br>2. BMQ