Preventing depression in aphasia: A cluster randomized control trial of the Aphasia Action Success Knowledge (ASK) program.
Aphasia
cluster randomized controlled trial
depression
prevention
psychosocial intervention
stroke
Journal
International journal of stroke : official journal of the International Stroke Society
ISSN: 1747-4949
Titre abrégé: Int J Stroke
Pays: United States
ID NLM: 101274068
Informations de publication
Date de publication:
10 2023
10 2023
Historique:
medline:
20
9
2023
pubmed:
8
5
2023
entrez:
8
5
2023
Statut:
ppublish
Résumé
Stroke patients with aphasia and their caregivers have higher incidence of depression than those without aphasia. The objective of the study is to determine whether a tailored intervention program (Action Success Knowledge; ASK) led to better mood and quality of life (QoL) outcomes than an attention control with a 12-month end point at cluster and individual participant level. A multi-site, pragmatic, two-level single-blind cluster randomized controlled trial compared ASK to an attention control (secondary stroke prevention program). Ten metropolitan and 10 non-metropolitan health regions were randomized. People with aphasia and their family members were recruited within 6 months post-stroke who scored ⩽12 on the Stroke Aphasic Depression Questionnaire Hospital Version-10 at screening. Each arm received manualized intervention over 6-8 weeks followed by monthly telephone calls. Blinded assessments of QoL and depression were taken at 12 months post-onset. Twenty clusters (health regions) were randomized. Trained speech pathologists screened 1744 people with aphasia and 373 participants consented to intervention (n = 231 people with aphasia and 142 family members). The attrition rate after consent was 26% with 86 and 85 participants with aphasia in the ASK arm and attention control arm, respectively, receiving intervention. Of those 171 who did receive treatment, only 41 met the prescribed minimum dose. Multilevel mixed effects modeling under the intention-to-treat protocol showed a significant difference on the Stroke and Aphasia Depression Questionnaire-21 (SADQ-21, N = 122, 17 clusters) in favor of the attention control (β = -2.74, 95% confidence interval (CI) = -4.76 to -0.73, p = 0.008). Individual data analysis using a minimal detectable change score for the SADQ-21 showed the difference was not meaningful. ASK showed no benefit over attention control in improving mood and preventing depression in people with aphasia or their family members.
Sections du résumé
BACKGROUND
Stroke patients with aphasia and their caregivers have higher incidence of depression than those without aphasia.
AIMS
The objective of the study is to determine whether a tailored intervention program (Action Success Knowledge; ASK) led to better mood and quality of life (QoL) outcomes than an attention control with a 12-month end point at cluster and individual participant level.
METHODS
A multi-site, pragmatic, two-level single-blind cluster randomized controlled trial compared ASK to an attention control (secondary stroke prevention program). Ten metropolitan and 10 non-metropolitan health regions were randomized. People with aphasia and their family members were recruited within 6 months post-stroke who scored ⩽12 on the Stroke Aphasic Depression Questionnaire Hospital Version-10 at screening. Each arm received manualized intervention over 6-8 weeks followed by monthly telephone calls. Blinded assessments of QoL and depression were taken at 12 months post-onset.
RESULTS
Twenty clusters (health regions) were randomized. Trained speech pathologists screened 1744 people with aphasia and 373 participants consented to intervention (n = 231 people with aphasia and 142 family members). The attrition rate after consent was 26% with 86 and 85 participants with aphasia in the ASK arm and attention control arm, respectively, receiving intervention. Of those 171 who did receive treatment, only 41 met the prescribed minimum dose. Multilevel mixed effects modeling under the intention-to-treat protocol showed a significant difference on the Stroke and Aphasia Depression Questionnaire-21 (SADQ-21, N = 122, 17 clusters) in favor of the attention control (β = -2.74, 95% confidence interval (CI) = -4.76 to -0.73, p = 0.008). Individual data analysis using a minimal detectable change score for the SADQ-21 showed the difference was not meaningful.
CONCLUSION
ASK showed no benefit over attention control in improving mood and preventing depression in people with aphasia or their family members.
Identifiants
pubmed: 37154589
doi: 10.1177/17474930231176718
pmc: PMC10507993
doi:
Banques de données
ANZCTR
['ACTRN12614000979651']
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
996-1004Références
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