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

ABSTRACT: Background: Electronic 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.

Methods: A 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.

Results: Of 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: ? coefficient 0.34; 95% CI -?0.14 to 0.83) and several quality-of-life domains in favour of the intervention group.

Conclusion: These findings support the need for further randomised effectiveness trials of the iVERVE program to be tested in people with new stroke.

Trial registration: ANZCTR, ACTRN12618001519246 . Registered on 11 September 2018-retrospectively registered.

SUBMITTER: Cadilhac DA

PROVIDER: S-EPMC7648386 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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

Cadilhac Dominique A DA Andrew Nadine E NE Busingye Doreen D Cameron Jan J Thrift Amanda G AG Purvis Tara T Li Jonathan C JC Kneebone Ian I Thijs Vincent V Hackett Maree L ML Lannin Natasha A NA Kilkenny Monique F MF

Pilot and feasibility studies 20201107 1

<h4>Background</h4>Electronic 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.<h4>Methods</h4>A phase I, prospective, randomised controlled pilot trial (1:1 allocation) with assessor blinding, intention-to-treat analysis, and a process eva ...[more]

PMID: 33292693

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Dataset Information

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

Publications

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

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