Pilot randomised clinical trial of an eHealth, self-management support intervention (iVERVE) for stroke: feasibility assessment in survivors 12–24 months post-event

Pilot and Feasibility Studies

Natasha A. Lannin¹  Ian Kneebone²  Jonathan C. Li³  Vincent Thijs⁴  Tara Purvis⁵  Amanda G. Thrift⁵  Nadine E. Andrew⁶  Dominique A. Cadilhac⁷  Monique F. Kilkenny⁷  Doreen Busingye⁸  Jan Cameron⁹  Maree L. Hackett^1,10 

[1] Department of Neurosciences, Central Clinical School, Monash University, Melbourne, VIC, Australia;Department of Allied Health (Occupational Therapy), Alfred Health, Melbourne, VIC, Australia;Discipline of Clinical Psychology, Graduate School of Health, University of Technology Sydney, Ultimo, NSW, Australia;Faculty of Engineering, Monash University, Clayton, VIC, Australia;Florey Institute of Neuroscience and Mental Health, The University of Melbourne, Heidelberg, VIC, Australia;Department of Medicine, Austin Health, Heidelberg, VIC, Australia;Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Level 3 Hudson Institute Building, 27-31 Wright Street, 3168, Clayton, VIC, Australia;Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Level 3 Hudson Institute Building, 27-31 Wright Street, 3168, Clayton, VIC, Australia;Department of Medicine, Peninsula Clinical School, Central Clinical School, Monash University, Frankston, VIC, Australia;Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Level 3 Hudson Institute Building, 27-31 Wright Street, 3168, Clayton, VIC, Australia;Florey Institute of Neuroscience and Mental Health, The University of Melbourne, Heidelberg, VIC, Australia;Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Level 3 Hudson Institute Building, 27-31 Wright Street, 3168, Clayton, VIC, Australia;NPS MedicineWise, Sydney, NSW, Australia;Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Level 3 Hudson Institute Building, 27-31 Wright Street, 3168, Clayton, VIC, Australia;School of Nursing and Midwifery, Monash University, Clayton, VIC, Australia;The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia;Faculty of Health and Wellbeing, The University of Central Lancashire, Preston, UK;

关键词: Stroke;    eHealth;    Feasibility studies;    Healthcare technology;   

DOI  :  10.1186/s40814-020-00706-x

来源: Springer

【 摘 要 】

BackgroundElectronic communication is used in various populations to achieve health goals, but evidence in stroke is lacking. We pilot tested the feasibility and potential effectiveness of a novel personalised electronic self-management intervention to support person-centred goal attainment and secondary prevention after stroke.MethodsA phase I, prospective, randomised controlled pilot trial (1:1 allocation) with assessor blinding, intention-to-treat analysis, and a process evaluation. Community-based survivors of stroke were recruited from participants in the Australian Stroke Clinical Registry (AuSCR) who had indicated their willingness to be contacted for research studies. Inclusion criteria include 1–2 years following hospital admission for stroke and living within 50 km of Monash University (Melbourne). Person-centred goals were set with facilitation by a clinician using a standardised template. The intervention group received electronic support messages aligned to their goals over 4 weeks. The control group received only 2–3 electronic administrative messages. Primary outcomes were study retention, goal attainment (assessed using Goal Attainment Scaling method) and satisfaction. Secondary outcomes were self-management (Health Education Impact Questionnaire: 8 domains), quality of life, mood and acceptability.ResultsOf 340 invitations sent from AuSCR, 73 responded, 68 were eligible and 57 (84%) completed the baseline assessment. At the goal-setting stage, 54/68 (79%) were randomised (median 16 months after stroke): 25 to intervention (median age 69 years; 40% female) and 29 to control (median age 68 years; 38% female). Forty-five (83%) participants completed the outcome follow-up assessment. At follow-up, goal attainment (mean GAS-T score ≥ 50) in the intervention group was achieved for goals related to function, participation and environment (control: environment only). Most intervention participants provided positive feedback and reported that the iVERVE messages were easy to understand (92%) and assisted them in achieving their goals (77%). We found preliminary evidence of non-significant improvements between the groups for most self-management domains (e.g. social integration and support: β coefficient 0.34; 95% CI − 0.14 to 0.83) and several quality-of-life domains in favour of the intervention group.ConclusionThese findings support the need for further randomised effectiveness trials of the iVERVE program to be tested in people with new stroke.Trial registrationANZCTR, ACTRN12618001519246. Registered on 11 September 2018—retrospectively registered.

【 授权许可】

CC BY