Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001247561
Ethics application status
Approved
Date submitted
27/09/2024
Date registered
11/10/2024
Date last updated
11/10/2024
Date data sharing statement initially provided
11/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The evaluation of a conversation treatment program for people with Parkinson's and their partners.
Scientific title
A Conversation Treatment Program for People with Parkinson’s and their Partners: The Feasibility and Effectiveness of a Clinical Trial involving Principles of Co-design.
Secondary ID [1] 313119 0
Nil known
Universal Trial Number (UTN)
U1111-1313-8139
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 335306 0
Condition category
Condition code
Neurological 331878 331878 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 331955 331955 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
RESEARCH PLAN

Participants

Data will be collected from 8-12 dyads (people with Parkinson’s and their partners), who will participate in four group therapy sessions held on a weekly basis. In between week one and week two, each dyad will also receive an individual therapy session with the speech pathologist to identify the specific barriers they face during conversations and to discuss the specific strategies they could use to support their conversations.

Participants with Parkinson’s who express an interest in taking part in the study, will be provided with information about the study. If they indicate that they do wish to take part, they will be asked sign the consent form.

Participants with Parkinson's and their partners/spouses will be recruited. For this study, a communication partner is defined as a partner/spouse who interacts with the person with Parkinson’s daily.

Consent process
Participants with Parkinson's and partners of people with Parkinson's who have been invited to participate will have the project explained to them via phone call by the HDR student. It will be made clear to them that participating is voluntary and they can choose not to take part. Once they have expressed an interest in taking part, the Telephone Interview of Cognitive Status (TICS - M) (de Jager et al., 2003) will be used with each participant with Parkinson’s via phone call, to assess their cognitive ability to consent to participation in the study. Participants will be excluded if they obtain a score of 18 or less, which is reported to be a sensitive indicator of mild cognitive dysfunction (de Jager et al., 2003).
The 'Hoehn and Yahn' classification as a quick indicator of general Parkinson's severity will also be completed with each participant with Parkinson’s via phone call. Participants will complete a single question that asks them to rate their Parkinson's symptoms in accordance with the Hoehn and Yahr scale (Hoehn & Yahr, 1967). The scale is widely used to assess the severity and progression of Parkinson's disease symptoms. It categorises individuals into one of five stages based on the severity of their motor symptoms. The scale will be slightly adapted for use in a self-report questionnaire format. Individuals will rate their Parkinson’s motor symptoms from 0 (no symptoms) to 5 (wheelchair bound, or bed ridden unless supported). Higher scores indicate more severe Parkinson's motor symptoms. The Hoehn and Yahr scale has high convergent validity and is strongly correlated with other Parkinson's symptom measures (Martignoni et al., 2003).

In addition to a verbal description of the project, all participants will be provided with an information sheet. They will be given the opportunity to ask questions about the study and also given the opportunity, if they wish, to discuss the study with their family before consenting to take part. Once participants have read the information sheet and been given the opportunity to ask questions, they will be given a consent form to sign. They will not participate in the study until the consent form has been signed. All participants will be provided with a copy of their consent form on request.

Design
The study will be trialled using a repeated measures experimental design and evaluated using a mixed-methods approach; quantitative behavioural and perceptual measures will be used in combination with qualitative data. If the project is unable to recruit the full number of participants, the results of this study may be presented in a case series format.

Method
People with Parkinson's and partners of people with Parkinson's who are deemed eligible to participate will be invited to take part in the treatment program.
The study will use a repeated measures experimental design. Before the treatment program, two baseline assessments will be conducted (Times 1 and 2), separated by 4 weeks, to assess for change when no treatment is given. The assessments will then be repeated immediately after the treatment program (Time 3). The design will therefore compare change when treatment is provided versus when no treatment is provided. All participants will receive the treatment program between Times 2 and 3. To accommodate for the availability of participants, the treatment program will be completed within 2-3 sets of groups aiming for four dyads in each group. This group therapy approach based on a common theme of interest, is consistent with the approach that people with Parkinson’s and their partners identified to be most useful to support their conversations during the previous co-design phase (phase 2a) of this PhD project.
The treatment program for each group will be delivered once a week for four weeks, each session lasting 90 minutes. All tasks will be administered by the HDR student (an experienced speech pathologist), guided by the protocol developed in consultation with people with Parkinson’s and their partners in the previous codesign phase. The treatment program will commence with a group session where participants get to know each other, and the speech pathologist introduces and explains the treatment program. Between week one and two, the speech pathologist will meet individually with each dyad to develop individual goals that they would like to achieve through this program using the conversation strategies explained to them by the speech pathologist. During the next three group therapy sessions, participants will practice their target conversation strategies within a group interaction about a common topic of interest (e.g., sports, music etc.).

For the group therapy sessions, examples of conversation strategies that will be used during treatment for the person with Parkinson's include:
1) Intentionally speaking louder with added effort.
2) Prepare for the conversation by wearing hearing aids, taking medication and choosing a time when one is not fatigue.
3) Manage environmental factors such as reduce background noise.
4) Prepare conversation starters and use open ended questions.

Examples of conversation strategies that will be used during treatment for the partner include:
1) Request a clarification if required.
2) Use short and succinct responses.
3) Use indirect prompts and feedback appropriately.
4) Show empathy towards the speaker.
5) Ensure both speaker and lister are in the same room and facing each other.

Strategies used to monitor adherence to the intervention include session attendance checklists, a reflection form to be filled at the end of each session on their reflections about the activities completed. Participants will also write their feedback about the homework they completed. throughput the past week.

The treatment effect will be assessed using both quantitative and qualitative measures. Quantitative measures will assess the impact of dysarthria on their quality of life, change in overall communicative effectiveness, and the degree of participation in conversations for people with Parkinson’s. The partner's skill to support conversations will also be measured. Conversation analysis (CA) (Goodwin & Heritage, 1990) of a short audio recording of the person with Parkinson’s and their CP conversing with each other on a regular topic will be completed. The speech pathologist will also work with each couple to develop individual goals that they will target during the conversation therapy program. Goal attainment scaling (GAS) (Turner-Stokes, 2009) will be used to quantify the achievement (or otherwise) of each goal.
A qualitative analysis of consumer perspectives about taking part in the treatment program, and their perceived changes in conversations post treatment will be completed using an interview guide and a six-item questionnaire adapted from similar prior studies (Cocks et al., 2013; Kearns et al., 2020; Worrall et al., 2011).

(The previous co-design phase was not registered on the ANZCTR. A brief overview of what was involved in this co-design phase include:
- Three people with Parkinson's and their partners (therefore, total six participants) attended six weekly workshop sessions with the HDR student who is an experienced Speech Pathologist. Each session was 1.5 hours long and spread over six weeks.
- Participants were presented with example program components used to support conversations with people with Parkinson's as well as other neurological conditions. They were invited to provide feedback and suggest their preferences to support conversations in the Parkinson's population.
- Participants together with the Speech Pathologist then designed the group therapy approach, frequency, duration, and materials for activities which will be trialled in this suggested phase of this project.)
Intervention code [1] 329625 0
Treatment: Other
Intervention code [2] 329626 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339490 0
The psychosocial impact of dysarthria on the individual's quality of life, from their perspective.
Timepoint [1] 339490 0
During face to face assessment sessions before the treatment is provided, repeated four weeks later before treatment is provided, and again immediately after completion of 4-week treatment program.
Primary outcome [2] 339492 0
The individual's ability to successfully communicate and convey messages to fulfill daily activities, from their perspective.
Timepoint [2] 339492 0
During face to face assessment sessions before the treatment is provided, repeated four weeks later before treatment is provided, and again immediately after completion of 4-week treatment program.
Primary outcome [3] 339562 0
The ability of the person with Parkinson’s to socially interact and engage with a communication partner, including responding to and/or initiating messages.
Timepoint [3] 339562 0
During face to face assessment sessions before the treatment is provided, repeated four weeks later before treatment is provided, and again immediately after completion of 4-week treatment program.
Secondary outcome [1] 440186 0
Acceptability, clinical and social validity measures. This will be assessed as a composite outcome.
Timepoint [1] 440186 0
The semi structured interviews and the questionnaire will be completed with each participant at the conclusion of the study. That is, immediately after completion of the 4-week treatment program.
Secondary outcome [2] 440445 0
Feasibility measures: Details on recruitment, attendance, and attrition will be reported. This will be assessed as a composite outcome.
Timepoint [2] 440445 0
Reported at the conclusion of study. That is, immediately after completion of the 4-week treatment program.
Secondary outcome [3] 440446 0
This is an additional primary outcome:
The ability of a communication partner to support the person with Parkinson’s, by using a communicative style which acknowledges their ability, supporting them to convey messages.
Timepoint [3] 440446 0
During face to face assessment sessions before the treatment is provided, repeated four weeks later before treatment is provided, and again immediately after completion of 4-week treatment program.
Secondary outcome [4] 440447 0
This is an additional primary outcome:
The quality of conversations between the person with Parkinson's and their partner.
Timepoint [4] 440447 0
During face to face assessment sessions before the treatment is provided, repeated four weeks later before treatment is provided, and again immediately after completion of 4-week treatment program.
Secondary outcome [5] 440448 0
This is an additional primary outcome:
Quantification of the achievement (or otherwise) of goals set by each dyad.
Timepoint [5] 440448 0
During face to face assessment sessions before the treatment is provided, repeated four weeks later before treatment is provided, and again immediately after completion of 4-week treatment program.
Secondary outcome [6] 440449 0
This is an additional primary outcome:
Each participant's perceived level of comfort in the group, confidence to communicate and success with communication goals.
Timepoint [6] 440449 0
During face to face assessment sessions before the treatment is provided, repeated four weeks later before treatment is provided, and again immediately after completion of 4-week treatment program.

Eligibility
Key inclusion criteria
Inclusion Criteria for Participants with Parkinson’s:
Inclusion criteria will comprise: a) be 18 years or older; b) have a self-reported diagnosis of idiopathic Parkinson’s disease (as indicated by a General practitioner, Geriatrician, or Neurologist); c) have English as their language of daily use; d) have sufficient vision and hearing abilities to participate in a group setting; e) be able to functionally engage and concentrate for 60–90-minute sessions; and e) experience difficulties in conversations with their partner/spouse due to difficulties arising from Parkinson’s disease (e.g., due to reduced volume of voice, reduced speech intelligibility).

Inclusion Criteria for Communication Partners:
Inclusion criteria will comprise: a) a partner/spouse who interacts with the person with Parkinson’s daily b) experiences difficulties in conversations with the person with Parkinson’s; and c) have English as their language of daily use.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria for Participants with Parkinson’s:
Exclusion criteria will comprise: a) have a history of brain damage; b) indicate they have a psychiatric diagnosis and/or behavioural disturbances; c) obtain a score of 18 or less on the Telephone Interview of Cognitive Status (TICS - M) (de Jager et al., 2003); and d) does not have a partner/spouse attending the group with them.

Exclusion Criteria for Communication Partners:
Exclusion criteria will comprise: a) paid carers, friends and family members other than a partner/spouse.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis
Aim 1: To evaluate the feasibility and effectiveness of the treatment program through a clinical trial.
The repeated measures data assessing impact of dysarthria, communicative effectiveness, participation in conversation and skill in supported conversation, will be statistically evaluated using a one-way repeated measures analysis of variance (ANOVA), as used with similarly designed studies (Cocks et al., 2022; Marshall et al., 2012). If the assumption of sphericity is violated, the Huynh–Feldt Epsilon adjustment will be applied. For outcome measures obtained once during the assessment phases, paired t-tests will be used to compare the pre- and post-intervention measures.

Aim 2: To evaluate the acceptability, clinical, and social validity of the treatment program, from the perspectives of the people with Parkinson’s and their partners who received the intervention.
Participants' perceptions regarding the treatment program will be evaluated using semi structured interviews and a six-item questionnaire using a five-point Likert-type scale (1 = not at all, 5 = very much). These items will examine participants' enjoyment of the sessions, usefulness of the content and perceived changes in conversations. This was adapted from similar previous studies (Cocks et al., 2013; Kearns et al., 2020; Worrall et al., 2011). A member of the research team who was not involved in the delivery of the treatment, will complete the interviews.
Interviews will be audio recorded and transcribed verbatim by the HDR student. To ensure reliability of information, the transcripts will then be reviewed against the recordings, for accuracy and missing information by the interviewer who completed the interviews. Subsequent discussions by the team will identify relevant themes and sub-themes using thematic analysis, by openly coding the data (Stevens, 1996) using NVIVO software (version 20.1.7.1). Data will be analysed using thematic analysis by following the four stages to theme development, namely initialisation, construction, verification and finalisation (Vaismoradi et al., 2016). To ensure rigour, texts assigned to codes will be compared by constant comparison to reach consensus on the code definitions and structure (Bradley et al., 2007). Any disagreements will be discussed and resolved by reviewing the transcripts together by the wider research team (Patton, 2002).
If an inadequate number of participants are recruited for group analysis, the results of this study may be presented in the form of a case series format.

To accommodate for the availability of participants, the treatment program will be completed within 2-3 sets of groups (same intervention for each group) aiming for four dyads in each group. This group therapy approach with four dyads in each group is consistent with the approach that people with Parkinson’s and their partners identified to be most useful to support their conversations during the previous co-design phase (phase 2a) of this PhD project.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 317511 0
Government body
Name [1] 317511 0
Australian Government Department of Education - Australian Government Research Training Program ScholarshipAustralian Government Research Training Program Scholarship
Country [1] 317511 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Country
Australia
Secondary sponsor category [1] 319810 0
None
Name [1] 319810 0
Address [1] 319810 0
Country [1] 319810 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316223 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 316223 0
Ethics committee country [1] 316223 0
Australia
Date submitted for ethics approval [1] 316223 0
Approval date [1] 316223 0
16/09/2024
Ethics approval number [1] 316223 0
HRE2023-0468

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137202 0
Miss Ramishka Thilakaratne
Address 137202 0
Curtin University, Kent St, Bentley WA 6102
Country 137202 0
Australia
Phone 137202 0
+61 452641442
Fax 137202 0
Email 137202 0
[email protected]
Contact person for public queries
Name 137203 0
Ramishka Thilakaratne
Address 137203 0
Curtin University, Kent St, Bentley WA 6102
Country 137203 0
Australia
Phone 137203 0
+61 452641442
Fax 137203 0
Email 137203 0
[email protected]
Contact person for scientific queries
Name 137204 0
Ramishka Thilakaratne
Address 137204 0
Curtin University, Kent St, Bentley WA 6102
Country 137204 0
Australia
Phone 137204 0
+61 452641442
Fax 137204 0
Email 137204 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.