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/37061720Actively Recruiting
Led by Parker Research Institute · Updated on 2025-01-27
32
Participants Needed
1
Research Sites
24 weeks
Total Duration
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
Cross-sectorial Management Program for People Living with Hand Osteoarthritis: a Randomised Controlled Pilot and Feasibility Study
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Total: 1 location
1
The Parker Institute
Copenhagen, Capital Region, Denmark, 2000
Actively Recruiting
U
Ulla Andersen, Master of occupational therapy
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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