Reducing the psychosocial impact of aphasia on mood and quality of life in people with aphasia and the impact of caregiving in family members through the Aphasia Action Success Knowledge (Aphasia ASK) program: Study protocol for a randomized controlled trial

Worrall, L; Ryan, B; Hudson, K; Kneebone, I; Simmons-Mackie, N; Khan, A; Hoffmann, T; Power, E; Togher, L; Rose, M

Reducing the psychosocial impact of aphasia on mood and quality of life in people with aphasia and the impact of caregiving in family members through the Aphasia Action Success Knowledge (Aphasia ASK) program: Study protocol for a randomized controlled trial

Worrall, L Ryan, B Hudson, K Kneebone, I

Simmons-Mackie, N Khan, A Hoffmann, T Power, E

Togher, L Rose, M

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Publication Type:: Journal Article
Citation:: Trials, 2016, 17 (1)
Issue Date:: 2016-03-22

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Field	Value	Language
dc.contributor.author	Worrall, L	en_US
dc.contributor.author	Ryan, B	en_US
dc.contributor.author	Hudson, K	en_US
dc.contributor.author	Kneebone, I https://orcid.org/0000-0003-3324-7264	en_US
dc.contributor.author	Simmons-Mackie, N	en_US
dc.contributor.author	Khan, A	en_US
dc.contributor.author	Hoffmann, T	en_US
dc.contributor.author	Power, E https://orcid.org/0000-0002-2638-0406	en_US
dc.contributor.author	Togher, L	en_US
dc.contributor.author	Rose, M	en_US
dc.date.available	2016-02-25	en_US
dc.date.issued	2016-03-22	en_US
dc.identifier.citation	Trials, 2016, 17 (1)	en_US
dc.identifier.uri	http://hdl.handle.net/10453/43831
dc.description.abstract	© 2016 Worrall et al. Background: People with aphasia and their family members are at high risk of experiencing post stroke depression. The impact of early interventions on mood and quality of life for people with aphasia is unknown. Methods/design: This study will determine whether an early intervention for both the person with aphasia after stroke and their family members leads to better mood and quality of life outcomes for people with aphasia, and less caregiver burden and better mental health for their family members. This is a multicenter, cluster-randomized controlled trial. Clusters, which are represented by Health Service Districts, will be randomized to the experimental intervention (Aphasia Action Success Knowledge Program) or an attention control (Secondary Stroke Prevention Information Program). People with aphasia and their family members will be blinded to the study design and treatment allocation (that is, will not know there are two arms to the study). Both arms of the study will receive usual care in addition to either the experimental or the attention control intervention. A total of 344 people with aphasia and their family members will be recruited. Considering a cluster size of 20, the required sample size can be achieved from 18 clusters. However, 20 clusters will be recruited to account for the potential of cluster attrition during the study. Primary outcome measures will be mood and quality of life of people with aphasia at 12 months post stroke. Secondary measures will be family member outcomes assessing the impact of caregiving and mental health, and self-reported stroke risk-related behaviors of people with aphasia. Discussion: This is the first known program tailored for people with aphasia and their family members that aims to prevent depression in people with aphasia by providing intervention early after the stroke. Trial registration: This trial is registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) as ACTRN12614000979651. Date registered: 11 September 2014.	en_US
dc.relation.ispartof	Trials	en_US
dc.relation.isbasedon	10.1186/s13063-016-1257-9	en_US
dc.subject.classification	Cardiovascular System & Hematology	en_US
dc.subject.classification	General & Internal Medicine	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Aphasia	en_US
dc.subject.mesh	Treatment Outcome	en_US
dc.subject.mesh	Clinical Protocols	en_US
dc.subject.mesh	Cluster Analysis	en_US
dc.subject.mesh	Depression	en_US
dc.subject.mesh	Affect	en_US
dc.subject.mesh	Family Relations	en_US
dc.subject.mesh	Mental Health	en_US
dc.subject.mesh	Research Design	en_US
dc.subject.mesh	Time Factors	en_US
dc.subject.mesh	Cost of Illness	en_US
dc.subject.mesh	Quality of Life	en_US
dc.subject.mesh	Caregivers	en_US
dc.subject.mesh	Australia	en_US
dc.subject.mesh	Stroke	en_US
dc.subject.mesh	Early Medical Intervention	en_US
dc.subject.mesh	Surveys and Questionnaires	en_US
dc.subject.mesh	Stroke Rehabilitation	en_US
dc.title	Reducing the psychosocial impact of aphasia on mood and quality of life in people with aphasia and the impact of caregiving in family members through the Aphasia Action Success Knowledge (Aphasia ASK) program: Study protocol for a randomized controlled trial	en_US
dc.type	Journal Article
utslib.citation.volume	1	en_US
utslib.citation.volume	17	en_US
utslib.for	1103 Clinical Sciences	en_US
utslib.for	1102 Cardiorespiratory Medicine and Haematology	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Arts and Social Sciences
pubs.organisational-group	/University of Technology Sydney/Graduate School of Health
utslib.copyright.status	open_access
pubs.issue	1	en_US
pubs.publication-status	Published	en_US
pubs.volume	17	en_US

Abstract:

© 2016 Worrall et al. Background: People with aphasia and their family members are at high risk of experiencing post stroke depression. The impact of early interventions on mood and quality of life for people with aphasia is unknown. Methods/design: This study will determine whether an early intervention for both the person with aphasia after stroke and their family members leads to better mood and quality of life outcomes for people with aphasia, and less caregiver burden and better mental health for their family members. This is a multicenter, cluster-randomized controlled trial. Clusters, which are represented by Health Service Districts, will be randomized to the experimental intervention (Aphasia Action Success Knowledge Program) or an attention control (Secondary Stroke Prevention Information Program). People with aphasia and their family members will be blinded to the study design and treatment allocation (that is, will not know there are two arms to the study). Both arms of the study will receive usual care in addition to either the experimental or the attention control intervention. A total of 344 people with aphasia and their family members will be recruited. Considering a cluster size of 20, the required sample size can be achieved from 18 clusters. However, 20 clusters will be recruited to account for the potential of cluster attrition during the study. Primary outcome measures will be mood and quality of life of people with aphasia at 12 months post stroke. Secondary measures will be family member outcomes assessing the impact of caregiving and mental health, and self-reported stroke risk-related behaviors of people with aphasia. Discussion: This is the first known program tailored for people with aphasia and their family members that aims to prevent depression in people with aphasia by providing intervention early after the stroke. Trial registration: This trial is registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) as ACTRN12614000979651. Date registered: 11 September 2014.

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http://hdl.handle.net/10453/43831