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

NCT06794632 | Recruiting DMC

• 1 other identifier: HANDY pilot-RCT
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hand Osteoarthritis

Keywords

Hand osteoarthritis; Activity of Daily Living; Group intervention

Outcome Measures

Primary Outcomes (2)

• 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

  up to 3 months

• 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

  up to 3 months

Secondary Outcomes (1)

• Observed ADL process ability

  up to 3 months

Other Outcomes (10)

• Selfreported health-related quality of life

  up to 3 months

• Selfreported pain

  up to 3 months

• Selfreported stiffness

  up to 3 months

Study Arms (2)

HANDY occupational therapy intervention

EXPERIMENTAL

Group-based occupational therapy

Other: HANDY occupational therapy intervention

Waiting list

NO INTERVENTION

Waiting list will receive no intervention (usual care)

Interventions

HANDY occupational therapy intervention OTHER

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.

HANDY occupational therapy intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People diagnosed by general practitioner with hand osteoarthritis
• Aged \> 18 years
• Experiencing decreased ADL ability

You may not qualify if:

• 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).

Sponsors & Collaborators

• Parker Research Institute: lead

Study Sites (1)

The Parker Institute

Copenhagen, Capital Region, 2000, Denmark

RECRUITING

Related Publications (10)

• Mellor K, Albury C, Dutton SJ, Eldridge S, Hopewell S. Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting. Pilot Feasibility Stud. 2023 Apr 15;9(1):59. doi: 10.1186/s40814-023-01291-5.

  PMID: 37061720 BACKGROUND

• Wallstrom A, Nordenskiold U. Assessing hand grip endurance with repetitive maximal isometric contractions. J Hand Ther. 2001 Oct-Dec;14(4):279-85. doi: 10.1016/s0894-1130(01)80006-5.

  PMID: 11762728 BACKGROUND

• Hawker GA, Mian S, Kendzerska T, French M. 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). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

  PMID: 22588748 BACKGROUND

• Wittrup-Jensen KU, Lauridsen J, Gudex C, Pedersen KM. Generation of a Danish TTO value set for EQ-5D health states. Scand J Public Health. 2009 Jul;37(5):459-66. doi: 10.1177/1403494809105287. Epub 2009 May 1.

  PMID: 19411320 BACKGROUND

• Billingham SA, Whitehead AL, Julious SA. 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. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.

  PMID: 23961782 BACKGROUND

• Wong G, Westhorp G, Manzano A, Greenhalgh J, Jagosh J, Greenhalgh T. RAMESES II reporting standards for realist evaluations. BMC Med. 2016 Jun 24;14(1):96. doi: 10.1186/s12916-016-0643-1.

  PMID: 27342217 BACKGROUND

• von Bulow C, Waehrens EE, Andersen U, Amris K, la Cour K. How a group-based occupational therapy program works in woman with fibromyalgia: A process evaluation of the ADAPT program. Scand J Occup Ther. 2023 Nov;30(8):1523-1540. doi: 10.1080/11038128.2023.2242380. Epub 2023 Aug 9.

  PMID: 37557901 BACKGROUND

• Hansen AO, Kristensen HK, Cederlund R, Moller S, Tromborg H. An occupation-based intervention in patients with hand-related disorders grouped using the sense of coherence scale-A randomized controlled trial. J Hand Ther. 2020 Oct-Dec;33(4):455-469. doi: 10.1016/j.jht.2019.12.009. Epub 2020 Mar 7.

  PMID: 32156580 BACKGROUND

• Hand C, Law M, McColl MA. Occupational therapy interventions for chronic diseases: a scoping review. Am J Occup Ther. 2011 Jul-Aug;65(4):428-36. doi: 10.5014/ajot.2011.002071.

  PMID: 21834458 BACKGROUND

• Steultjens EM, Dekker J, Bouter LM, Leemrijse CJ, van den Ende CH. Evidence of the efficacy of occupational therapy in different conditions: an overview of systematic reviews. Clin Rehabil. 2005 May;19(3):247-54. doi: 10.1191/0269215505cr870oa.

  PMID: 15859525 BACKGROUND

Related Links

• Related Info

Central Study Contacts

Ulla Andersen, Master of occupational therapy

CONTACT

004520286578; ulla.andersen.03@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study is designed as a two-armed parallel pilot RCT following the CONSORT guideline - extension for pilot and feasibility trials. Following baseline assessments, participants will be randomised either to the HANDY occupational therapy intervention or usual care.

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 27, 2025
• Study Start: January 13, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)