Who will be entered into the trial?
Patients will be eligible for randomisation into the trial if they have a confirmed diagnosis of idiopathic PD as defined by the UK PDS Brain Bank Criteria and report problems with voice or speech.
Patients will be excluded if they have dementia (as defined by the patient’s clinician), have evidence of laryngeal pathology, or have received speech and language therapy in the last 24 months.They will also be ineligible if their clinician is certain that they will require SLT in the next 6 months.
Following randomisation into the trial, and referral to the speech and language therapy team, how long can elapse before the therapist starts to deliver the therapy intervention?
The initial SLT assessments should occur within 4 weeks of patient randomisation. The therapy interventions should be completed within 3 months post-randomisation.
In what setting should the therapy be delivered?
The therapy can be delivered in any setting other than inpatient i.e. the patients must be living in their own homes at the time of intervention. The intervention will most likely be delivered in whatever setting you would normally provide therapy in your particular services. However, the setting of therapy may also be dependent on the individual goals of the patient and the equipment and resources required to deliver the treatment needed.
A dose of 6 sessions delivered by the speech and language therapist over a period of 6 weeks is recommended. Does the therapy delivered have to match up to this recommended dose?
No. The recommended dose provided in the trial literature reflects the median dose reported in survey literature for SLT practice in current services. Again, it is not meant to be prescriptive and the dose of therapy delivered should reflect a patient’s individual needs. We recognise that some patients will require more than 6 visits whilst others may require less. The only constraint is that the therapy should be completed before the patient’s assessment at 3 months post-randomisation.
When delivering the intervention, can I monitor the patient’s progress through outcome measures?
Yes. The patient will be assessed for the purposes of the trial at a number of assessment points (randomisation, 3 months, 6 months and 12 months) through posted, self-completed outcome measures. However, it is acceptable to utilise outcome measures throughout the delivery of therapy sessions to inform the progression and dose of your treatment.
How should I record the therapy assessment and interventions delivered for patients within the trial?
All findings of assessments and interventions delivered for patients during the trial should be recorded as in your normal practice in the patient’s individual notes. In addition we will ask you to summarise the intervention delivered for each patient in an intervention log for each session. The intervention logs are available to download from the PD COMM Pilot website.
Will training be made available for therapists in the PD COMM Pilot study?
Yes. The PD COMM team will be running training sessions throughout the duration of the trial to provide education on PD, and to enable the therapists participating in the trial to come together and share their experiences.
If a patient is assessed and found to require no treatment do I need to complete an intervention log?
Yes. An intervention log should be completed as well as an initial assessment log for the first visit. If no treatment is given or needed, this can be recorded.