PERsonalized SPEeCh Therapy for actIVE Conversation

Study Overview
=================
Brief Summary
-----------------
Background: Up to 70% of the patients with Parkinson's Disease (PD) experience speech problems, which cause a diminished intelligibility. A reduced intelligibility has a profound negative impact on social interaction and quality of life. Since pharmacological treatment only has limited effects on speech, non-pharmacological treatment, like speech therapy, is particularly relevant. Cochrane reviews (Herd et al., 2012a; Herd et al., 2012b) showed that evidence for speech therapy in PD is increasing, but is still inconclusive. Moreover, only very intensive standardized treatment programs have been studied, which are only feasible for people with mild to moderate PD, but too intensive for people with advanced PD. Here, the investigators will perform the first large-scale study to demonstrate the efficacy of speech therapy in PD patients in all disease stages on quality of life and speech quality. Objective: The aim is to demonstrate the effectiveness of personalized and home-based speech therapy on quality of life, intelligibility and social participation for people with Parkinson's disease who have a reduced intelligibility of speech. Methods: The investigators will perform a single blind, randomized and controlled trial. A total of 215 patients (18 years and older) with PD in all disease stages who have difficulty with intelligibility affecting daily communication will participate in this study. The patients will be randomly allocated to either speech therapy or a waiting list control group (1:1 ratio). Speech therapy using telerehabilitation will be provided for 8 weeks which consists of 12-16 sessions. The control group will receive deferred treatment after 8 weeks. The measurements will take place before the randomization (To), after 8 weeks (T1), and for the experimental group also after 24 weeks (T2). The primary outcome measure is quality of life, as measured using the total score on the PDQ-39. Secondary outcome measures include speech and voice, speech intelligibility, non-motor symptoms and caregiver burden. Hypothesis: The investigators hypothesize that patients in all disease stages can improve their speech intelligibility by using the explicit feedback from external cues provided by instructed caregivers plus a dedicated smartphone/ tablet app (the Voice Trainer app).

Official Title
-----------------
The PERSPECTIVE Study: PERsonalized SPEeCh Therapy for actIVE Conversation

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Other: Speech therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of idiopathic PD; Problems in intelligibility affecting daily communication (as indicated by the patient and/or the caregiver); A desire for improvement; willing and able to receive online treatment Exclusion Criteria: Recent (<1 year) speech therapy; Voice or speech problems due to other causes; Communication difficulties based on language problems without predominantly reduced intelligibility; inability to receive online treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Speech therapy, right after T0 (baseline measurement). | Other: Speech therapy<br>* Online speech therapy, delivered by specialized speech therapists. Speech therapy will be complemented by a real-time visual feedback app (the Voice Trainer app).<br>|
| No Intervention: Control group<br>Patients will be on a waiting list for 8 weeks. After the primary endpoint (T1), patients will receive speech therapy. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-specific health-related quality of life | Parkinson's Disease Questionnaire (PDQ-39) | Baseline (T0), primary endpoint after 8 weeks (T1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech quality | Radboud Dysarthria Assessment (RDA) | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) | 
| Voice quality | Acoustic Voice Quality Index (AVQI) | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) | 
| Voice handicap | Voice Handicap Index (VHI) | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) | 
| Severity of voice and speech complaints, reported by patient | Radboud Oral Motor inventory for Parkinson's disease (ROMP) | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) | 
| Severity of voice and speech complaints, reported by caregiver | Radboud Oral Motor inventory for Parkinson's disease (ROMP), adapted to caregiver | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) | 
| Speech intelligibility | Dutch intelligibility test - sentence level (NSVO-Z) | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) | 
| Caregiver burden | Zarit caregiver Burden Interview Short Form (ZBI-12) | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) | 
| Mood and anxiety | Hospital Anxiety and Depression Scale (HADS) | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2). Minimum score = 0 (no anxiety or depression), maximum score = 42 (most anxiety or depression). | 
| Health-related quality of life | EuroQol-5D (EQ-5D) | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) | 
| Swallowing | Maximum swallowing speed (timed test) | Baseline (T0), primary endpoint after 8 weeks (T1), follow-up after 32 weeks (T2) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Speech therapy, Telerehabilitation, Quality of life