JJR Macleod Centre for Diabetes Endocrinology & Metabolism, Aberdeen, AB25 2ZN Scotland, United Kingdom.
Vascular Department, Aberdeen Royal Infirmary, Aberdeen, AB25 2ZN Scotland, United Kingdom.
J Vasc Nurs. 2021 Mar;39(1):11-16. doi: 10.1016/j.jvn.2020.10.001. Epub 2020 Nov 3.
This pilot study reports the feasibility of a future randomized controlled trial (RCT) investigating the effect of supported self-management through low-intensity psychological intervention in patients with peripheral arterial disease (PAD) resulting in claudication. The study protocol, measurement instrument, data collection, and analysis were evaluated. Clinical outcome measures include depression and anxiety scores, smoking cessation, activity (step count), weight, and quality of life. Both Quantitative and Qualitative data were collected to evaluate participant experience and the clinical impact of a supported self-management intervention delivered in a routine clinical setting.
Participants received an initial one to one assessment with a health psychologist. Demographic data and baseline clinical outcome measures were recorded. These included Hospital Anxiety and Depression Scale score (HADS), health-related quality of life questionnaire (EQ-5D-3 L), number of cigarettes smoked daily, weight/BMI, and daily step count. Participants each received an activity tracker to record daily step count and were followed up weekly to provide psychological input, including goal setting, overcoming barriers, and preventing relapse. Quantitative data collection was scheduled at baseline, 3 and 6 months (final follow-up). At the final follow-up, participants provided qualitative feedback reflecting upon their experience of the intervention and its impact. Descriptive statistical analysis and simple paired samples t-test were employed in data evaluation.
The sample size was small (n = 30). Twenty-three participants were followed up to 6 months. Depression scores improved with statistical significance from baseline to 6-month follow-up. Eight participants stopped smoking (47% reduction); a further 9 greatly reduced their intake. A borderline statistically significant increase of daily step count was achieved between baseline and 6-month follow-up. In addition, positive weight loss trends were observed in a predominantly obese or overweight cohort. The qualitative feedback highlighted participants understood and embraced the information delivered regarding the importance of health behavior change. Participants were able to link tailored action plans with what mattered to them with the help of the Health Psychologist.
This study embraces the contemporary ideology of enabling self-management of long-term conditions to improve clinical outcomes. As a pilot study, we have shown that an expanded, randomized controlled trial is both safe and feasible. A positive trend in clinical outcomes suggests this patient group may benefit from supported self-management through low-intensity psychological intervention, where other forms of early intervention have historically faltered.
本研究旨在报告一项未来随机对照试验（RCT）的可行性，该试验旨在研究通过低强度心理干预支持自我管理对因跛行而导致外周动脉疾病（PAD）的患者的影响。评估了研究方案、测量工具、数据收集和分析。临床结果测量包括抑郁和焦虑评分、戒烟、活动（步数）、体重和生活质量。收集了定量和定性数据，以评估参与者的体验以及在常规临床环境中提供支持性自我管理干预的临床影响。
参与者接受了健康心理学家的初步一对一评估。记录了人口统计学数据和基线临床结果测量，包括医院焦虑和抑郁量表评分（HADS）、健康相关生活质量问卷（EQ-5D-3L）、每天吸烟的数量、体重/身体质量指数和每天步数。参与者每人都收到了一个活动追踪器来记录每天的步数，并每周进行随访以提供心理投入，包括设定目标、克服障碍和预防复发。定量数据收集在基线、3 个月和 6 个月（最终随访）进行。在最终随访时，参与者提供了反映干预体验及其影响的定性反馈。采用描述性统计分析和简单配对样本 t 检验进行数据分析。
样本量较小（n=30）。23 名参与者随访至 6 个月。抑郁评分从基线到 6 个月随访时显著改善。8 名参与者戒烟（减少 47%）；另外 9 名参与者大大减少了吸烟量。与基线相比，6 个月随访时每天步数有统计学意义上的增加。此外，在肥胖或超重为主的队列中观察到体重呈正下降趋势。定性反馈强调参与者理解并接受了有关健康行为改变重要性的信息。在健康心理学家的帮助下，参与者能够将量身定制的行动计划与对他们重要的事情联系起来。
本研究采用了使慢性病患者能够自我管理以改善临床结果的当代理念。作为一项试点研究，我们已经表明，扩大的随机对照试验既安全又可行。临床结果的积极趋势表明，这类患者可能受益于通过低强度心理干预进行的支持性自我管理，而在其他形式的早期干预中，这一患者群体历来效果不佳。
