OBJECTIVE: This study aims to perform a pilot randomized controlled trial assessing the acceptability, feasibility, and preliminary effectiveness of a 30-day digitally-enabled community health worker (CHW) intervention in HF.
METHODS: Adults hospitalized with a diagnosis of HF at an academic hospital were randomly assigned to receive digitally-enabled CHW care (intervention; digital platform +CHW) or CHW-enhanced usual care (control; CHW only) for 30 days after hospital discharge. Primary outcomes were feasibility (use of the platform) and acceptability (willingness to use the platform in the future). Secondary outcomes assessed preliminary effectiveness (30-day readmissions, emergency department visits, and missed clinic appointments).
RESULTS: A total of 56 participants were randomized (control: n=31; intervention: n=25) and 47 participants (control: n=28; intervention: n=19) completed all trial activities. Intervention participants who completed trial activities wore the digital sensor on 78% of study days with mean use of 11.4 (SD 4.6) hours/day, completed symptom questionnaires on 75% of study days, used the blood pressure monitor 1.1 (SD 0.19) times/day, and used the digital weight scale 1 (SD 0.13) time/day. Of intervention participants, 100% responded very or somewhat true to the statement \"If I have access to the [platform] moving forward, I will use it.\" Some (n=9, 47%) intervention participants indicated they required support to use the digital platform. A total of 19 (100%) intervention participants and 25 (89%) control participants had ≥5 CHW interactions during the 30-day study period. All intervention (n=19, 100%) and control (n=26, 93%) participants who completed trial activities indicated their CHW interactions were \"very satisfying.\" In the full sample (N=56), fewer participants in the intervention group were readmitted 30 days after hospital discharge compared to the control group (n=3, 12% vs n=8, 26%; P=.12). Both arms had similar rates of missed clinic appointments and emergency department visits.
CONCLUSIONS: This pilot trial of a digitally-enabled CHW intervention for HF demonstrated feasibility, acceptability, and a clinically relevant reduction in 30-day readmissions among participants who received the intervention. Additional investigation is needed in a larger trial to determine the effect of this intervention on HF home management and clinical outcomes.
BACKGROUND: Clinicaltrials.gov NCT05130008; https://clinicaltrials.gov/study/NCT05130008.
UNASSIGNED: RR2-10.2196/55687.
目的:为了进行飞行员RCT评估可接受性,可行性,以及30天数字支持CHW干预HF的初步有效性。
方法:在某学术医院诊断为心力衰竭住院的成年人在出院后30天内被随机分配接受数字化支持的CHW护理(干预;数字平台+CHW)或CHW增强的常规护理(对照;仅CHW)。主要结果是可行性(平台的使用)和可接受性(未来使用平台的意愿)。次要结果评估初步有效性(30天再入院,急诊科(ED)访问,和错过诊所预约)。
结果:共有56名参与者被随机分组(N=31名对照;N=25名干预),47名参与者(N=28名对照;N=19名干预)完成了所有试验活动。完成试验活动的干预参与者在78.0%的研究日佩戴数字传感器,平均使用11.4小时/天(SD4.6)。在75%的研究日完成症状问卷,使用血压计1.1次/天(SD=0.19),并使用数字体重秤1次/天(SD=0.13)。在干预参与者中,89.5%的人非常或有点真实地回答了“如果我可以进入[平台]前进,我会用它。9名(47.4%)的干预参与者表示,他们需要支持才能使用数字平台。在30天的研究期间,有19名(100%)干预参与者和25名(89.3%)对照参与者的CHW相互作用≥5。完成试验活动的所有干预(N=19[100%])和对照(N=26[92.9%])参与者表示他们的CHW相互作用非常令人满意。\“在完整样本中(N=56),与对照组相比,干预组出院后30天再次入院的参与者较少(3[12%]vs8[25.8%];P=0.12).两组都有相似的错过诊所预约和ED就诊率。
结论:这项数字化CHW干预HF的试点试验证明了可行性,可接受性,在接受干预的参与者中,30日再入院的临床相关性减少.需要在更大的试验中进行额外的调查,以确定这种干预对HF家庭管理和临床结果的影响。
背景:Clinicaltrials.govNCT05130008。
■RR2-10.2196/55687。