Occupational therapy addressing the ability to perform activities of daily living among persons living with chronic conditions: a randomised controlled pilot study of ABLE 2.0

Vita Hagelskjær, Kristina Tomra Nielsen, Cecilie von Bülow, Maud Graff, Eva Ejlersen Wæhrens, Vita Hagelskjær, Kristina Tomra Nielsen, Cecilie von Bülow, Maud Graff, Eva Ejlersen Wæhrens

Abstract

Background: 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.

Methods: 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).

Results: 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.

Conclusions: 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.

Trial registration: The study was registered at ClinicalTrials.gov (Identifier: NCT04295837 ) on December 5th, 2019. Retrospectively registered.

Keywords: ADL ability; Complex interventions; Everyday life; Goal setting; Occupational Therapy Intervention Process Model (OTIPM); Rehabilitation.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
The ABLE 2.0 Intervention Program including a brief case example. 1 GAS levels of scoring: The level of goal attainment is described using an ordinal scale from −2 to +2. The actual level of performance is described at level −1, and the expected level is described at level 0. Levels +1 and +2 are descriptions of what the person will be able to, if he or she achieves more than expected. Level −2 describes the level, where the person achieves less than expected. ADL=Activities of Daily Living; ADL-I= Activities of Daily Living-Interview; AMPS=Assessment of Motor and Process Skills; COPD= Chronic Obstructive Pulmonary Disease; GAS=Goal Attainment Scaling, OT=Occupational Therapist; PEO=Person Environment Occupation; TMO=Transactional Model of Occupation
Fig. 2
Fig. 2
CONSORT diagram for pilot and feasibility trials: the ABLE 2.0 pilot

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