The ABLE intervention was developed to enhance the ability to perform activities of daily living (ADL) tasks among persons living with chronic conditions. ABLE is a generic, home-based, individualised, 8-week occupational therapy intervention program, developed to be delivered in Danish municipalities. In a previous study, the feasibility of ABLE was evaluated in terms of content and delivery. In this pilot study, the remaining feasibility aspects of a randomised controlled trial including (i) trial procedures (recruitment and retention), (ii) randomisation, (iii) adherence to program, (iv) feasibility of additional outcome measurements, and (iv) access to information on usual occupational therapy were evaluated. The study was conducted in a Danish municipality, using a two-armed parallel randomised controlled design, planning a recruitment strategy including 20 persons living with one/more chronic conditions and experiencing problems performing ADL. The following progression criteria were used to determine if a future full-scale randomised controlled trial was feasible: (i) recruitment (50% met the eligibility criteria) and retention (80%), (ii) randomisation (80% accepted randomisation, procedure was executed as planned), (iii) adherence to program (100% followed the treatment protocol), (iv) outcome measurements (80% of the participants delivered relevantly and fully answered questionnaires), and (v) usual occupational therapy (extraction of needed information was successful). Due to the COVID-19 pandemic, the study was truncated resulting in limited but sufficient data to answer most of the study questions. (i) Eighteen of 37 eligible persons (48.6%) were recruited; of those treated (n = 6), all remained (100%); (ii) 18 accepted randomisation (100%), and procedure was effective; (iii) ABLE was delivered with adherence (100%); (iv) 92.3–100% of the participants gave relevant and complete answers in two of three questionnaires; and (v) needed information on usual occupational therapy was extractable in seven of nine aspects. Proceeding to full-scale trial is recommendable; however, a few adjustments on outcome measurements, inclusion criteria and extraction of information on usual occupational therapy are needed. The study was registered at ClinicalTrials.gov (Identifier: NCT04295837 ) on December 5th, 2019. Retrospectively registered.

中文翻译：

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职业治疗解决慢性病患者日常生活活动的能力：ABLE 2.0 的随机对照试验研究

ABLE 干预旨在提高慢性病患者执行日常生活活动 (ADL) 任务的能力。ABLE 是一项通用的、以家庭为基础的、个性化的、为期 8 周的职业治疗干预计划，旨在在丹麦市政当局实施。在之前的一项研究中，ABLE 的可行性是从内容和交付方面进行评估的。在这项试点研究中，随机对照试验的其余可行性方面包括 (i) 试验程序（招募和保留），（ii）随机化，（iii）遵守计划，（iv）额外结果测量的可行性，以及（iv） ) 对常规职业治疗信息的获取进行了评估。该研究是在丹麦的一个自治市进行的，采用双臂平行随机对照设计，计划招募策略，包括 20 名患有一种/​​多种慢性病并在执行 ADL 时遇到问题的人 以下进展标准用于确定未来的全面随机对照试验是否可行：(i) 招募（50% 符合资格标准）和保留（80%），（ii）随机化（80% 接受随机化，程序按计划执行），(iii) 遵守计划（100% 遵循治疗方案），(iv) 结果测量（80% 的参与者提供相关且完全回答的问卷），以及 (v) 常规职业治疗（提取所需的信息已成功）。由于 COVID-19 大流行，该研究被截断，导致数据有限但足以回答大多数研究问题。(i) 37 名合格人员中的 18 名 (48. 6%) 被招募；在接受治疗的人中（n = 6），全部保留（100%）；(ii) 18 个接受的随机化 (100%)，并且程序有效；(iii) ABLE 交付时依从性 (100%)；(iv) 92.3-100% 的参与者在三份问卷中的两份中给出了相关且完整的答案；(v) 可以从九个方面中的七个方面提取有关常规职业治疗的所需信息。建议进行全面试验；然而，需要对结果测量、纳入标准和常规职业治疗信息的提取进行一些调整。该研究于2019年12月5日在ClinicalTrials.gov注册（标识符：NCT04295837）。追溯注册。(iii) ABLE 交付时依从性 (100%)；(iv) 92.3-100% 的参与者在三份问卷中的两份中给出了相关且完整的答案；(v) 可以从九个方面中的七个方面提取有关常规职业治疗的所需信息。建议进行全面试验；然而，需要对结果测量、纳入标准和常规职业治疗信息的提取进行一些调整。该研究于2019年12月5日在ClinicalTrials.gov注册（标识符：NCT04295837）。追溯注册。(iii) ABLE 交付时依从性 (100%)；(iv) 92.3-100% 的参与者在三份问卷中的两份中给出了相关且完整的答案；(v) 可以从九个方面中的七个方面提取有关常规职业治疗的所需信息。建议进行全面试验；然而，需要对结果测量、纳入标准和常规职业治疗信息的提取进行一些调整。该研究于2019年12月5日在ClinicalTrials.gov注册（标识符：NCT04295837）。追溯注册。需要对结果测量、纳入标准和常规职业治疗信息的提取进行一些调整。该研究于2019年12月5日在ClinicalTrials.gov注册（标识符：NCT04295837）。追溯注册。需要对结果测量、纳入标准和常规职业治疗信息的提取进行一些调整。该研究于2019年12月5日在ClinicalTrials.gov注册（标识符：NCT04295837）。追溯注册。