About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
People diagnosed by general practitioner with hand osteoarthritis
Aged > 18 years
Experiencing decreased ADL ability
Disqualifiers
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).
Trial design
Parallel
Treatments tested in this trial
HANDY occupational therapy intervention
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Observed ADL motor ability
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
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
Secondary outcomes
Observed ADL process ability
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 process ability based on Rasch measurement models and reported in logits. Higher measures indicate higher ADL process ability
Other outcomes
Selfreported health-related quality of life
Selfreported health-related quality of life will be assessed by the European Quality of life 5 Dimensions (EQ-5D) including five quistions and visual analogue scale. The five quistions (Mobility; Self-care; Usual activities; Pain/Discomfort; Anixiety/Depression) on a likert scale 1 to 5 (1= very low degree, 5= very high degree). The visual analogue scale (0 to 100) with zero representing the worst health imagined and 100 the best health imagined.
Selfreported pain
Change in selfreported hand pain will be assessed using the Australian Canadian Osteoarthritis Hand Index (AUSCAN) questionnaire . AUSCAN items are rated on a visual analogue scale from zero mm (no symptoms) to 100 mm (worst symptoms), AUSCAN pain subscales will be reported in cm based on item sum scores for each subscale: pain (five items, score 0 to 50).
Selfreported stiffness
Change in selfreported hand stiffness will be assessed using the Australian Canadian Osteoarthritis Hand Index (AUSCAN) questionnaire. AUSCAN items are rated on a visual analogue scale from zero mm (no symptoms) to 100 mm (worst symptoms), AUSCAN subscales were reported in cm based on item sum scores for each subscale: stiffness (one item, score 0 to10).
Selfreported function
Selfreported function function will be assessed using the Australian Canadian Osteoarthritis Hand Index (AUSCAN) questionnaire. AUSCAN items are rated on a visual analogue scale from zero mm (no symptoms) to 100 mm (worst symptoms), AUSCAN subscales were reported in cm based on item sum scores for each subscale: function (nine items, score 0 to 90).
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