Pilot randomised clinical trial of an eHealth, self-management support intervention (iVERVE) for stroke: feasibility assessment in survivors 12-24 months post-event.
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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DOI：
10.1186/s40814-020-00706-x
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发表时间：
2020-11-07
影响因子：
1.7
通讯作者：
ReCAPS investigators
中科院分区：
文献类型：
--
作者：
Cadilhac DA;Andrew NE;Busingye D;Cameron J;Thrift AG;Purvis T;Li JC;Kneebone I;Thijs V;Hackett ML;Lannin NA;Kilkenny MF;ReCAPS investigators
电子通信在不同人群中用于实现健康目标，但缺乏中风的证据。我们试点测试了一种新的个性化电子自我管理干预的可行性和潜在有效性，以支持以人为本的目标实现和中风后的二级预防。一项I期、前瞻性、随机对照初步试验（1：1分配），包括评估者设盲、意向治疗分析和过程评价。从澳大利亚卒中临床登记处（AuSCR）的参与者中招募了基于社区的卒中幸存者，这些参与者表示愿意联系他们进行研究。入选标准包括中风入院后1-2年，居住在距离莫纳什大学（墨尔本）50公里以内。以人为本的目标是由临床医生使用标准化模板的促进。干预组在4周内收到与其目标一致的电子支持信息。对照组仅收到2-3条电子管理信息。主要结果是研究保留，目标实现（使用目标实现量表方法评估）和满意度。次要结果是自我管理（健康教育影响问卷：8个领域），生活质量，情绪和可接受性。在AuSCR发出的340份邀请中，73份作出了答复，68份符合资格，57份（84%）完成了基线评估。在目标设定阶段，54/68例（79%）被随机分配（卒中后中位数16个月）：25例接受干预（中位年龄69岁; 40%为女性），29例接受对照（中位年龄68岁; 38%为女性）。45名（83%）参与者完成了结局随访评估。在随访时，干预组在功能、参与和环境（对照：仅环境）相关目标方面实现了目标（平均GAS-T评分≥ 50）。大多数干预参与者提供了积极的反馈，并报告说，iVERVE信息易于理解（92%），并帮助他们实现目标（77%）。我们发现，在大多数自我管理领域（例如社会融合和支持：β系数为0.34; 95% CI为-0.14至0.83）和几个生活质量领域，干预组之间的改善并不显著。这些发现支持了对iVERVE项目进行进一步随机有效性试验的必要性，这些试验将在新发卒中患者中进行测试。ANZCTR，ACTRN 12618001519246。于2018年9月11日注册-追溯注册。在线版本包含补充材料，可通过10.1186/s40814-020-00706-x获得。
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. 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. 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: β coefficient 0.34; 95% CI − 0.14 to 0.83) and several quality-of-life domains in favour of the intervention group. These findings support the need for further randomised effectiveness trials of the iVERVE program to be tested in people with new stroke. ANZCTR, ACTRN12618001519246. Registered on 11 September 2018—retrospectively registered. The online version contains supplementary material available at 10.1186/s40814-020-00706-x.
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影响因子：
3.5
作者：
Andrew, N. E.;Kilkenny, M. F.;Cadilhac, D. A.
通讯作者：
Cadilhac, D. A.
影响因子：
3.5
作者：
Chen, Poyu;Lin, Keh-Chung;Chang, Ku-Chou
通讯作者：
Chang, Ku-Chou
影响因子：
1.7
作者：
Hilari, Katerina;Behn, Nicholas;Goldsmith, Kimberley
通讯作者：
Goldsmith, Kimberley
影响因子：
3.4
作者：
Aben, I;Verhey, F;Honig, A
通讯作者：
Honig, A
影响因子：
120.7
作者：
Chow, Clara K.;Redfern, Julie;Thiagalingam, Aravinda
通讯作者：
Thiagalingam, Aravinda