Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06794632

Cross-sectorial Management Program for People with Hand Osteoarthritis A Randomised Controlled Pilot Study of the HANDY Occupational Therapy Intervention

Led by Parker Research Institute · Updated on 2025-01-27

32

Participants Needed

1

Research Sites

24 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the HANDY program version 2.0, a cross-sectorial management program designed for people living with hand osteoarthritis (HOA). The study is a pilot randomized controlled trial (RCT) to test the feasibility, recruitment, retention, and acceptability of this occupational therapy intervention. The program aims to improve the ability to perform daily activities that are often impaired by HOA, such as dressing, eating, and cooking. This pilot study builds on a previous feasibility study and incorporates stakeholder input to refine the program before a full-scale RCT. The HANDY program includes an organizational part where general practitioners (GPs) evaluate the need for occupational therapy referral based on hand function and daily activity challenges. The occupational therapy intervention consists of six 120-minute sessions combining individual and group activities focused on compensatory strategies like energy conservation, assistive devices, and goal setting. Participants receive one individual home session at the start and end to assess and evaluate their daily activity abilities and four group sessions involving peer learning and strategy training. Participants with HOA will be assessed for eligibility and referred by their GP. During the study, they will complete self-reported and observed measures of daily activity ability, goal attainment, and quality of life at baseline and after the intervention. Researchers will also collect data on recruitment, retention, intervention acceptability, and mechanisms of action through registration forms, diaries, and focus group interviews. The study runs from January to June 2025 and includes follow-up assessments to inform a future larger trial.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • People diagnosed by general practitioner with hand osteoarthritis
  • Aged > 18 years
  • Experiencing decreased ADL ability
Not Eligible

You will not qualify if you...

  • Severe vision loss
  • Severe hearing loss
  • Cognitive deficits affecting the ability to engage in peer-learning activities
  • Unable to participate in two or more group sessions due to other scheduled activities (e.g. holidays/travels)
  • Acute illness is the primary reason for decreased ADL ability (Will be referred to other services in the municipality)

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Parker Institute

Copenhagen, Capital Region, Denmark, 2000

Actively Recruiting

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Research Team

U

Ulla Andersen, Master of occupational therapy

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial

Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting.

Katie Mellor, Charlotte Albury, Susan J Dutton...

https://pubmed.ncbi.nlm.nih.gov/37061720

Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP).

Gillian A Hawker, Samra Mian, Tetyana Kendzerska...

https://pubmed.ncbi.nlm.nih.gov/22588748

An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database.

Sophie A M Billingham, Amy L Whitehead, Steven A Julious

https://pubmed.ncbi.nlm.nih.gov/23961782

How a group-based occupational therapy program works in woman with fibromyalgia: A process evaluation of the ADAPT program.

Cecilie von Bülow, Eva Ejlersen Wæhrens, Ulla Andersen...

https://pubmed.ncbi.nlm.nih.gov/37557901

An occupation-based intervention in patients with hand-related disorders grouped using the sense of coherence scale-A randomized controlled trial.

Alice Ørts Hansen, Hanne Kaae Kristensen, Ragnhild Cederlund...

https://pubmed.ncbi.nlm.nih.gov/32156580

Evidence of the efficacy of occupational therapy in different conditions: an overview of systematic reviews.

Esther M J Steultjens, Joost Dekker, Lex M Bouter...

https://pubmed.ncbi.nlm.nih.gov/15859525
Cross-sectorial Management Program for People with Hand Osteoarthritis A Randomised Controlled Pilot Study of the HANDY Occupational Therapy Intervention | DecenTrialz