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Recruiting Not applicable

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

NCT06794632 · tracked via the Priya Life Science Denmark tracker
Sponsor
Parker Research Institute
Phase
Not applicable
Started
2025-01-13
Last updated
2025-01-27

Condition(s) studied

Hand Osteoarthritis

Investigational drug(s) / intervention(s)

HANDY occupational therapy intervention

HANDY occupational therapy intervention: The HANDY occupational therapy intervention is occupation-centred and follows the Occupational Therapy Intervention Process Model (OTIPM), 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 hand osteoarthritis, facilitated by two OTs.

Study summary

To investigate the research design (pilot-RCT) and feasibility of the HANDY program for people with hand osteoarthritis (version 2.0). In collaboration with two municipalities (Lyngby-Taarbæk and Ballerup), the research design is tested in a pilot-RCT before planning a full-scale RCT study. The entire HANDY program is described in a manual, which has been adjusted to version 2.0 based on a previous feasibility study. The focus of the study will be on procedures related to recruitment and retention, the study's acceptance in practice, and the appropriateness of assessment tools in connection with the occupational therapy group intervention. The feasibility and acceptance of the HANDY program version 2.0 are also examined in this study.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * People diagnosed by general practitioner with hand osteoarthritis * Aged \> 18 years * Experiencing decreased ADL ability Exclusion Criteria: * 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).

Primary outcome measure(s)

  • Observed ADL motor ability — up to 3 months
    Change in observed ADL motor ability, using the Assessment of Motor and Process Skills (AMPS). Raw ordinal scores are converted into linear, interval scale (i.e. infinite scale) measures of ADL motor ability based on Rasch measurement models and reported in logits. Higher measures indicate higher ADL motor ability
  • Selfreported ADL ability — up to 3 months
    Change in self-reported ADL ability, using the standardised ADL-Interview (ADL-I). Raw ordinal scores are converted into linear, interval scale (i.e. infinite scale) measures of self-reported ADL ability based on Rasch measurement models and reported in logits. Higher measures indicate higher self-reported ADL ability

Trial sites (1)

FacilityCityRegionStatus
The Parker Institute Copenhagen Capital Region Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06794632 on ClinicalTrials.gov ↗ ← All trials in Denmark