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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorParker Research Institute

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • HANDY occupational therapy intervention

    Other 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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: HANDY occupational therapy interventionExperimental treatment 1 intervention
Group B: Waiting listNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
up to 3 months
2

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

Time frame
up to 3 months

Secondary outcomes

1

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

Time frame
up to 3 months

Other outcomes

1

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.

Time frame
up to 3 months
2

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).

Time frame
up to 3 months
3

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).

Time frame
up to 3 months
4

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).

Time frame
up to 3 months

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