AphasiaNCT05225922
Effect of Communication Partner Training Program for the Management of Persons With Aphasia
A study testing Communication Partner Training and Usual Speech and language Therapy in people with Aphasia, run by Riphah International University at 1 site in Pakistan.
Trial summary
Communication Partner Training (CPT) is an evidence-based intervention that teaches communication partners (e.g., family members, friends, healthcare workers) how to best support conversation and interaction for a person with aphasia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aphasia
- What is being tested?
- Communication Partner Training and Usual Speech and language Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 5 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participant's aphasia must be caused by stroke and to have occurred at least 12 months before the study takes place.
- The participant's aphasia could be of all degrees of severity (clinically assessed as mild, moderate, or severe on GCS).
- The participants with aphasia are required to be 18 years or older, living at home or planned to live at home after rehabilitation, and have no other speech or language impairments (such as severe dysarthria)
- Others have to communicate with the person with aphasia on a regular basis (at least once a week).
Who cannot join
- The participants will be excluded if the persons with aphasia:
- Are diagnosed with dementia or any other known significant cognitive impairment.
- Have significant hearing or vision problems.
- Have known alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Communication Partner Training (CPT) is an evidence-based intervention that teaches communication partners (e.g., family members, friends, healthcare workers) how to best support conversation and interaction for a person with aphasia. It does not matter how mild or severe a person's aphasia is, they can be a good candidate for CPT as long as their communication partner is motivated and willing to adapt their communication style. The objective of this study is to see the effects of communication partner training for the management of persons with aphasia. A randomized controlled trial will be conducted. In total, 6 dyads will be randomly assigned to the intervention (CPT program) or usual care (control) group. Statistical Package for Social Sciences (SPSS) V 25. will be used for Data analysis. Results will be extracted. Conclusion will be made after comparing the pre and post treatment results on person with aphasia.
Read the detailed description
Communication Partner Training (CPT) is an evidence-based intervention that teaches communication partners (e.g., family members, friends, healthcare workers) how to best support conversation and interaction for a person with aphasia. It does not matter how mild or severe a person's aphasia is, they can be a good candidate for CPT as long as their communication partner is motivated and willing to adapt their communication style. The objective of this study is to see the effects of communication partner training for the management of persons with aphasia. A randomized controlled trial will be conducted. In total, 6 dyads will be randomly assigned to the intervention (CPT program) or usual care (control) group. The intervention group received usual care in addition to a CPT program, which consisted of face-to-face education and counselling sessions, a manual and telephone support. Data will be collected at baseline, three months, and six months. The main outcome for caregivers will be using appropriate conversational skills that will be measured by the Conversational Skills Rating Scale (CSRS). Secondary outcomes for patients will be health-related quality of life that will be measured by the Quality of Life (QOL) Scale. To see the effective communication between patient and communication partner, Communicative Effectiveness Index (CETI) will be used.
- Conditions
- Aphasia
- Being tested
- Communication Partner Training, Usual Speech and language Therapy
- Keywords
- Aphasia, Post Stroke, Communication Partner Training
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication Partner TrainingBehavioural
This intervention aims to improve the language, communication, participation and overall quality of life of the Person with Aphasia.
Usual Speech and language TherapyOther
This group will receive usual speech and language therapy session.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Communication Partner Training:The group will receive usual care in addition to a CPT program, which will consist of face-to-face education and counselling sessions, a manual and telephone support. Receives: Behavioral: Communication Partner Training |
| Comparison Group | Active comparator | This group will receive usual speech therapy sessions. Receives: Other: Usual Speech and language Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversational Skills
Enhanced Communication skills in terms of attentiveness, expressiveness, coordination and composure. Skills ranging from Inadequate (1) to Excellent (5).
Measured: 6 Months
Quality of communication life
Increased quality of communication life on quality of communication life scale , higher rating showing more positivity.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Nov 2023
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fazaila Ehsan, PhD*, Principal investigator, Riphah International UniversityNazia Mumtaz, PhD, Study director, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225922
- Sponsor's protocol ID
- REC/LHR/21/1110 Fazaila Ehsan
- Status last verified
- Dec 2024
- First submitted
- 29 Dec 2021
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simmons-Mackie N, Raymer A, Armstrong E, Holland A, Cherney LR. Communication partner training in aphasia: a systematic review. Arch Phys Med Rehabil. 2010 Dec;91(12):1814-37. doi: 10.1016/j.apmr.2010.08.026.
PubMed 21112422Lock S, Wilkinson R, Bryan K, Maxim J, Edmundson A, Bruce C, Moir D. Supporting Partners of People with Aphasia in Relationships and Cconversation (SPPARC). Int J Lang Commun Disord. 2001;36 Suppl:25-30. doi: 10.3109/13682820109177853.
PubMed 11340791Kagan A, Black SE, Duchan FJ, Simmons-Mackie N, Square P. Training volunteers as conversation partners using "Supported Conversation for Adults with Aphasia" (SCA): a controlled trial. J Speech Lang Hear Res. 2001 Jun;44(3):624-38. doi: 10.1044/1092-4388(2001/051).
PubMed 11407567Chang HF, Power E, O'Halloran R, Foster A. Stroke communication partner training: a national survey of 122 clinicians on current practice patterns and perceived implementation barriers and facilitators. Int J Lang Commun Disord. 2018 Nov;53(6):1094-1109. doi: 10.1111/1460-6984.12421. Epub 2018 Aug 27.
PubMed 30151877Croteau C, McMahon-Morin P, Le Dorze G, Baril G. Impact of aphasia on communication in couples. Int J Lang Commun Disord. 2020 Jul;55(4):547-557. doi: 10.1111/1460-6984.12537. Epub 2020 May 13.
PubMed 32400928Johansson MB, Carlsson M, Sonnander K. Communication difficulties and the use of communication strategies: from the perspective of individuals with aphasia. Int J Lang Commun Disord. 2012 Mar-Apr;47(2):144-55. doi: 10.1111/j.1460-6984.2011.00089.x. Epub 2011 Oct 25.
PubMed 22369055
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Communication Partner Training Program for the Management of Persons With Aphasia
- ClinicalTrials.gov ID
- NCT05225922
- Acronym / sponsor ID
- REC/LHR/21/1110 Fazaila Ehsan
- Conditions
- Aphasia
- Keywords
- Aphasia, Post Stroke, Communication Partner Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Communication Partner Training (CPT) is an evidence-based intervention that teaches communication partners (e.g., family members, friends, healthcare workers) how to best support conversation and interaction for a person with aphasia. It does not matter how mild or severe a person's aphasia is, they can be a good candidate for CPT as long as their communication partner is motivated and willing to adapt their communication style. The objective of this study is to see the effects of communication partner training for the management of persons with aphasia. A randomized controlled trial will be conducted. In total, 6 dyads will be randomly assigned to the intervention (CPT program) or usual care (control) group. Statistical Package for Social Sciences (SPSS) V 25. will be used for Data analysis. Results will be extracted. Conclusion will be made after comparing the pre and post treatment results on person with aphasia.
Detailed description
Communication Partner Training (CPT) is an evidence-based intervention that teaches communication partners (e.g., family members, friends, healthcare workers) how to best support conversation and interaction for a person with aphasia. It does not matter how mild or severe a person's aphasia is, they can be a good candidate for CPT as long as their communication partner is motivated and willing to adapt their communication style. The objective of this study is to see the effects of communication partner training for the management of persons with aphasia. A randomized controlled trial will be conducted. In total, 6 dyads will be randomly assigned to the intervention (CPT program) or usual care (control) group. The intervention group received usual care in addition to a CPT program, which consisted of face-to-face education and counselling sessions, a manual and telephone support. Data will be collected at baseline, three months, and six months. The main outcome for caregivers will be using appropriate conversational skills that will be measured by the Conversational Skills Rating Scale (CSRS). Secondary outcomes for patients will be health-related quality of life that will be measured by the Quality of Life (QOL) Scale. To see the effective communication between patient and communication partner, Communicative Effectiveness Index (CETI) will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Communication Partner TrainingCommunication Partner Training:The group will receive usual care in addition to a CPT program, which will consist of face-to-face education and counselling sessions, a manual and telephone support. |
| Comparison Group | Active comparator | Other: Usual Speech and language TherapyThis group will receive usual speech therapy sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The participant's aphasia must be caused by stroke and to have occurred at least 12 months before the study takes place.
- The participant's aphasia could be of all degrees of severity (clinically assessed as mild, moderate, or severe on GCS).
- The participants with aphasia are required to be 18 years or older, living at home or planned to live at home after rehabilitation, and have no other speech or language impairments (such as severe dysarthria)
- Others have to communicate with the person with aphasia on a regular basis (at least once a week).
Key exclusion criteria (4 listed)
- Are diagnosed with dementia or any other known significant cognitive impairment.
- Have significant hearing or vision problems.
- Have known alcohol or drug abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication Partner TrainingThis intervention aims to improve the language, communication, participation and overall quality of life of the Person with Aphasia. | Behavioural | Experimental |
| Usual Speech and language TherapyThis group will receive usual speech and language therapy session. | Other | Comparison Group |
Primary outcome
Conversational Skills
Time frame: 6 Months
Enhanced Communication skills in terms of attentiveness, expressiveness, coordination and composure. Skills ranging from Inadequate (1) to Excellent (5).
Quality of communication life
Time frame: 6 Months
Increased quality of communication life on quality of communication life scale , higher rating showing more positivity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 21112422Simmons-Mackie N, Raymer A, Armstrong E, Holland A, Cherney LR. Communication partner training in aphasia: a systematic review. Arch Phys Med Rehabil. 2010 Dec;91(12):1814-37. doi: 10.1016/j.apmr.2010.08.026.
- Background: PubMed 11340791Lock S, Wilkinson R, Bryan K, Maxim J, Edmundson A, Bruce C, Moir D. Supporting Partners of People with Aphasia in Relationships and Cconversation (SPPARC). Int J Lang Commun Disord. 2001;36 Suppl:25-30. doi: 10.3109/13682820109177853.
- Background: PubMed 11407567Kagan A, Black SE, Duchan FJ, Simmons-Mackie N, Square P. Training volunteers as conversation partners using "Supported Conversation for Adults with Aphasia" (SCA): a controlled trial. J Speech Lang Hear Res. 2001 Jun;44(3):624-38. doi: 10.1044/1092-4388(2001/051).
- Background: PubMed 30151877Chang HF, Power E, O'Halloran R, Foster A. Stroke communication partner training: a national survey of 122 clinicians on current practice patterns and perceived implementation barriers and facilitators. Int J Lang Commun Disord. 2018 Nov;53(6):1094-1109. doi: 10.1111/1460-6984.12421. Epub 2018 Aug 27.
- Background: PubMed 32400928Croteau C, McMahon-Morin P, Le Dorze G, Baril G. Impact of aphasia on communication in couples. Int J Lang Commun Disord. 2020 Jul;55(4):547-557. doi: 10.1111/1460-6984.12537. Epub 2020 May 13.
- Background: PubMed 22369055Johansson MB, Carlsson M, Sonnander K. Communication difficulties and the use of communication strategies: from the perspective of individuals with aphasia. Int J Lang Commun Disord. 2012 Mar-Apr;47(2):144-55. doi: 10.1111/j.1460-6984.2011.00089.x. Epub 2011 Oct 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fazaila Ehsan, PhD* principal investigator
Riphah International University
Nazia Mumtaz, PhD study director
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication Partner Training and Usual Speech and language Therapy in people with Aphasia, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversational Skills (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05225922, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.