Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB)

被引:27
作者
Hilari, Katerina [1 ]
Behn, Nicholas [1 ]
Marshall, Jane [1 ]
Simpson, Alan [2 ]
Thomas, Shirley [3 ]
Northcott, Sarah [1 ]
Flood, Chris [2 ]
McVicker, Sally [4 ]
Jofre-Bonet, Mireia [5 ]
Moss, Becky [1 ]
James, Kirsty [6 ]
Goldsmith, Kimberley [6 ]
机构
[1] City Univ London, Ctr Language & Commun Sci Res, Sch Hlth Sci, Northampton Sq, London EC1V 0HB, England
[2] City Univ London, Ctr Mental Hlth Res, Sch Hlth Sci, Northampton Sq, London EC1V 0HB, England
[3] Univ Nottingham, Queens Med Ctr, Med Sch, Div Rehabil & Ageing,Sch Med, Floor B, Nottingham NG7 2UH, England
[4] City Univ London, Aphasia Reconnect City, Ctr Language & Commun Sci Res, Sch Hlth Sci, Northampton Sq, London EC1V 0HB, England
[5] City Univ London, Dept Econ, Sch Arts & Social Sci, Northampton Sq, London EC1V 0HB, England
[6] Kings Coll London, Biostat & Hlth Informat Dept, Div Psychol & Syst Sci, Inst Psychiat Psychol & Neurosci, De Crespigny Pk, London, England
关键词
Stroke; Aphasia; Peer support; Peer befriending; Randomised controlled trial; Feasibility; Behavioural intervention; SOCIAL-ISOLATION; PSYCHOMETRIC PROPERTIES; DEPRESSION; PEOPLE; OUTCOMES; DESIGN; CONTEXT; SCALE; TOOL;
D O I
10.1186/s40814-019-0397-6
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Background: Despite the high prevalence of mood problems after stroke, evidence on effective interventions particularly for those with aphasia is limited. There is a pressing need to systematically evaluate interventions aiming to improve wellbeing for people with stroke and aphasia. This study aims to evaluate the feasibility of a peer-befriending intervention. Methods/design: SUPERB is a single blind, parallel group feasibility trial of peer befriending for people with aphasia post-stroke and low levels of psychological distress. The trial includes a nested qualitative study and pilot economic evaluation and it compares usual care (n = 30) with usual care + peer befriending (n = 30). Feasibility outcomes include proportion screened who meet criteria, proportion who consent, rate of consent, number of missing/incomplete data on outcome measures, attrition rate at follow-up, potential value of conducting main trial using value of information analysis (economic evaluation), description of usual care, and treatment fidelity of peer befriending. Assessments and outcome measures (mood, wellbeing, communication, and social participation) for participants and significant others will be administered at baseline, with outcome measures re-administered at 4 and 10 months post-randomisation. Peer befrienders will complete outcome measures before training and after they have completed two cycles of befriending. The qualitative study will use semi-structured interviews of purposively sampled participants (n = 20) and significant others (n = 10) from both arms of the trial, and all peer befrienders to explore the acceptability of procedures and experiences of care. The pilot economic evaluation will utilise the European Quality of life measure (EQ-5D-5 L) and a stroke-adapted version of the Client Service Receipt Inventory (CSRI). Discussion: This study will provide information on feasibility outcomes and an initial indication of whether peer befriending is a suitable intervention to explore further in a definitive phase III randomised controlled trial.
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页数:16
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