Cross-sectorial Management Program for People Living with Hand Osteoarthritis: a Randomised Controlled Pilot and Feasibility Study

Background Globally, nearly 600 million people are affected by osteoarthritis (OA), causing pain and stiffness (1). Hand OA (HOA) is the second most common subtype of OA. People with HOA often experience decreased ability to perform Activities of Daily Living (ADL) (2,3)This includes Personal ADL (PADL) tasks such as getting dressed, eating, and performing manicure, and Instrumental ADL (IADL) tasks, such as hot and cold meal preparation, cleaning, and bicycling (4). Research suggests that occupational therapy interventions are effective in improving ADL ability among people with chronic conditions (5-7). Still, rigorous studies, testing the outcomes of occupational therapy introducing compensatory strategies (e.g., strategy training, assistive devices, and splints) to reduce symptoms and improve ADL ability in people with HOA are limited (8,9). Furthermore, a recent audit among Danish general practitioners (n=348) indicates that among people with HOA experiencing decreased ADL ability (n=147) only one was referred for occupation therapy (10).

Accordingly, to ensure that people with HOA are referred for and will receive effective occupational therapy interventions, the development of a multidisciplinary cross-sectorial management program for people with HOA, named HANDY, was initiated in 2023. In the development process, the United Kingdom's Medical Research Council's (MRC) framework for developing and evaluating complex interventions was employed (11). The MRC framework prescribes four phases: 1) development, 2) feasibility/piloting, 3) evaluation, and 4) implementation (11). As recommended by the MRC framework, a core element in the development of the HANDY program has been the involvement of stakeholders through co-productional activities (12) to ensure the sustainability of the HANDY program. Accordingly, the content and delivery of the HANDY program was based on the experiences and preferences among people with HOA, clinicians (i.e., general practitioners (GPs), occupational therapists (OTs), rheumatologists), and previous research (5,13-18).

The manualised HANDY program consists of two parts: an organizational part and an occupational therapy intervention part. The organizational part includes 1) a needs evaluation conducted by the GP to clarify the client's need for referral to occupational therapy, 2) procedures for referral for occupational therapy in the municipality, and 3) procedures for the cross-sectorial communication and collaboration between the GP and OT (19). The occupational therapy part of the program will be delivered in the municipality and includes: an individual session evaluating the ADL ability of the person with HOA and establishing goals for the intervention; four group-based sessions involving peer-learning activities using compensatory strategies; homework between sessions; and an individual session re-evaluating the individual's ADL ability(19).

A feasibility study, of the first version of the HANDY program (v1.0), based on the guidance developed by O'Cathain and al (20), was carried out from January to June 2024, addressing the following feasibility aspects (19): 1) Intervention development, 2) Intervention components, 3) Perceived value, benefits, harms or unintended consequences, 4) Acceptability in principle, 5) Feasibility and acceptability in practice, and 6) Fidelity, reach and dose. The results of the feasibility study revealed needs to i) improve identification of people with HOA in need for occupational therapy in the general practices; ii) establish a stronger connection between the evaluation of ADL ability and goal setting (first session) and the solutions presented in the group sessions; iii) improve the learning activity designed to support participants in gaining a transactional understanding of their problems with ADL, and iv) improve procedures for homework. Based on these results, the second version of the HANDY program (v2.0) was developed.

In accordance with the MRC framework (11) and the guidelines by O'Cathain and al. (20), the next step will be to conduct a study to evaluate remaining feasibility aspects and pilot aspects of trial design, conduct and processes, outcomes, and measures, prior to initiating a full scale randomised controlled trial (RCT) of the HANDY program (v.2.0).

Methods Specific aims

Based on the guidance by O'Cathain and al. (20), the specific study aims are to:

1. Pilot central aspects of trial design, conduct and processes in terms of:

* effectiveness of recruitment, randomisation, and retention (Recruitment and retention). * acceptability of study procedures (Acceptability of the trial in practice). * appropriateness of outcomes and measurements (Breadth and selection of outcomes) * completion of outcome measures (Completion of measures) 2. Evaluate remaining feasibility aspects:

* Explore mechanisms of actions assumed to be essential for the HANDY occupational therapy intervention to produce the intended outcomes (Mechanisms of action). * Explore if the revised HANDY program (v 2.0) is feasible and acceptable, based on adjustments made (Feasibility and acceptability in practice).

Study design and settings The HANDY pilot study is designed as a two-armed parallel RCT following the CONSORT guideline (21). Following baseline assessments, participants will be randomised either to the HANDY occupational therapy intervention or usual care. Since people with HOA rarely are referred from GP to OT, usual care represents no intervention. Accordingly, to mimic real-life settings and enhance the applicability of the study results, the control group will consist of a waiting list. Outcomes assessments will be carried out at baseline and post intervention (week 7). After study completion, participants in the control group will be offered the occupational therapy intervention part of the HANDY program.

The study will be conducted between January 1st and June 30th, 2025, in two municipalities previously involved in the feasibility study of the HANDY 1.0 program, both located in the Capital Region of Denmark (19).

Participants and recruitment People diagnosed by GP with HOA, aged \> 18 years, experiencing decreased ADL ability due to HOA, without severe vision and hearing loss, or cognitive deficits affecting the ability to engage in peer-learning activities and group discussions. People unable to participate in two or more group sessions due to other scheduled activities (e.g. holidays/travels) are not eligible. Furthermore, people where acute illness is the primary reason for decreased ADL ability, will be referred to other services in the municipality.

Participants with HOA will be recruited through various approaches. First, GPs working in general practices in the municipalities involved will be introduced to the needs evaluation and referral procedures of the HANDY program (v2.0) and asked to suggest study participation to people in their clinic with need for occupational therapy due to HOA. Second, posters informing on the HANDY pilot study will be posted in GP clinics and municipal rehabilitation centres. The posters will include information about who will be eligible, study period, and encourage people with HOA experiencing decreased ADL ability to ask their GP for a referral. Also, contact information to researchers will be provided, if any question arises or the need of assistance occurs.

The GP will decide if referral for occupational therapy is relevant, based on the needs evaluation. When the referral for occupational therapy is received in the municipality, the person with HOA meeting the study inclusion criteria will be informed about the pilot study and invited to participate. Information will include allocation, trial procedures, and the rights to withdraw. If the person wants to participate in the study, written consent is obtained. People not meeting the inclusion criteria or not interested in study participation, will be offered a standard occupational therapy session to clarify if other municipal services are relevant.

OTs, working in each of the municipal rehabilitation centres involved, with at least six months of working experience in this type of setting will be responsible for the delivery of the HANDY program. To support the delivery, the OTs will be trained in procedures related to the HANDY program v2.0.

The HANDY program Organisational part (Needs evaluation, referral and communication) The needs evaluation is conducted by the GP to determine if the HOA affects the client's performance of ADL tasks. It is based on the GP's assessment and the client's perspective. First, the GP asks questions on how the person with HOA perceives using the hands in performance of ADL tasks (e.g., zipping zippers when dressing, cutting nails, opening cans when cooking, or wringing a cloth when cleaning). Then a screening involving seven aspects is conducted: 1) decreased grip strength, 2) problems turning things with the hands, for example turning a key in a lock, or turning a rounded doorknob or handle, 3) problems related to turning taps on and off, 4) problems peeling vegetables or fruit, 5) problems picking up big, heavy thing, 6) problems wringing a washcloth or dishcloth, and 7), problems related to buttoning buttons. Grip strength is assessed using simple handshake (i.e., GP's assessment), and the remaining aspects are assessed by asking the person with HOA (i.e., self-report). All aspects are rated as "yes" or "no". The person with HOA is referred to occupational therapy based on rating at least one of the five aspects as "yes".

Referral is conducted using existing electronic procedures. As part of the referral the GP takes an anamnesis focusing on the level of functioning and the identified problems related to ADL. Also, the specific diagnosis is included. In the municipality, the referral is received and processed according to standard procedures.

Immediately after the final session of the occupational therapy intervention, the OT submits a medical discharge summary to the GP, representing the primary part of the cross-sectorial communication and Collaboration. The summary includes information on the level of goal-attainment, obtained changes in ADL-I and AMPS measures, descriptions of any referrals to other services (e.g., assistive devices or assistance in the home) and future recommendations.

Occupational Therapy Intervention The HANDY occupational therapy intervention is occupation-centred and follows the Occupational Therapy Intervention Process Model (OTIPM) (22), specifying the steps of a problem-solving process focused on enabling performance of tasks in everyday life. The HANDY occupational therapy intervention consists of six mandatory sessions of 120 minutes representing a combination of individual and group sessions. Each group includes a maximum of eight participants with HOA, facilitated by two OTs.

Session 1 consists of an individual session in the person with HOA's home involving evaluations of self-reported and observed ADL task performance. The Activities of Daily Living Interview (ADL-I) is used to measure self-reported ADL ability (23), and the Assessment of Motor and Process Skills (AMPS) to measure observed ADL ability (24,25). Both ADL-I and AMPS are valid and reliable measurements for people with chronic conditions. Following the ADL evaluations, the person with HOA and the OT will together formulate goals for the intervention using the Goal Attainment Scale (GAS) (26) and together consider reasons for decreased ADL ability.

Sessions 2 to 5 are group-based, held at the rehabilitation centre, and involve peer learning activities. In session 2 the people with HOA are introduced to how a transactional perspective can identify factors not only related to hand function but influencing their individual ADL task performances (22). The results of the individual analyses form the basis for sessions 3 to 5 focusing on improving ADL task

• Observed ADL process ability [Срок оценки: up to 3 months]