NCT06254105

Brief Summary

To support the referral of people with Hand Osteoarthritis (HOA) to evidence-based occupational therapy addressing decreased ADL ability, a cross-sectorial management program for people with HOA, named HANDY, was developed. The HANDY program includes procedures for needs evaluation and referral, and a group-based occupational therapy program. The development was based on the United Kingdom's Medical Research Councils recommendations. A core element is involvement of stakeholders. Therefore, the research group has worked closely with GPs, OTs, people with HOA and specialist within rheumatology. Through a co-productional process the HANDY program was developed based on theories, research evidence, current best practice and the preferences of people with HOA. The aim of this study is to evaluate the feasibility of the HANDY

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

January 22, 2024

Last Update Submit

February 23, 2024

Conditions

Keywords

FeasibilityOccupational therapyHand Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Participant flow

    Counts of participant flow

    up to 6 months

Secondary Outcomes (6)

  • Registration forms from GP

    up to 6 months

  • Registration forms from OT

    up to 6 months

  • Registration forms from people with hand osteoarthritis

    up to 2 months

  • Observation based ADL motor ability

    up to 2 months

  • Observation based ADL process ability

    up to 2 months

  • +1 more secondary outcomes

Study Arms (1)

Intervention group

EXPERIMENTAL

Receive the HANDY programme

Other: HANDY programme

Interventions

The manualised HANDY program includes descriptions of procedures related to the GP's evaluation of the client's need for referral to occupational therapy, procedures for referral from the GP to community-based occupational therapy, the group-based occupational therapy programme, and recommendations related to collaboration and communication between GP and occupational therapist.

Intervention group

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People diagnosed with hand OA, \> 18 years and motivated to participate in a group program focusing on improvement in ADL task performance
  • General practitioners (GPs) working in a clinic with agreement with the Danish health insurance receiving patients with all kinds of everyday symptoms and illnesses, who express interest in contributing to development and evaluation of a program for people with hand OA.
  • Occupational therapists (OTs) working with community-based rehabilitation and with six months of community-based working experience

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parker Institute

Frederiksberg, Capital Region, 2000, Denmark

RECRUITING

Related Publications (23)

  • GBD 2021 Low Back Pain Collaborators. Global, regional, and national burden of low back pain, 1990-2020, its attributable risk factors, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 May 22;5(6):e316-e329. doi: 10.1016/S2665-9913(23)00098-X. eCollection 2023 Jun.

    PMID: 37273833BACKGROUND
  • Haugen IK, Englund M, Aliabadi P, Niu J, Clancy M, Kvien TK, Felson DT. Prevalence, incidence and progression of hand osteoarthritis in the general population: the Framingham Osteoarthritis Study. Ann Rheum Dis. 2011 Sep;70(9):1581-6. doi: 10.1136/ard.2011.150078. Epub 2011 May 27.

    PMID: 21622766BACKGROUND
  • Andersen U; Doessing, A; Gudbergsen, H; Hagelskjaer, V ; Bliddal, H; Waehrens, EE. Indicators of need for Occupational Therapy. Pending publication.

    BACKGROUND
  • Bukhave EB, Huniche L. Activity problems in everyday life--patients' perspectives of hand osteoarthritis: "try imagining what it would be like having no hands". Disabil Rehabil. 2014;36(19):1636-43. doi: 10.3109/09638288.2013.863390. Epub 2013 Dec 6.

    PMID: 24308906BACKGROUND
  • Kloppenburg M, Kroon FP, Blanco FJ, Doherty M, Dziedzic KS, Greibrokk E, Haugen IK, Herrero-Beaumont G, Jonsson H, Kjeken I, Maheu E, Ramonda R, Ritt MJ, Smeets W, Smolen JS, Stamm TA, Szekanecz Z, Wittoek R, Carmona L. 2018 update of the EULAR recommendations for the management of hand osteoarthritis. Ann Rheum Dis. 2019 Jan;78(1):16-24. doi: 10.1136/annrheumdis-2018-213826. Epub 2018 Aug 28.

    PMID: 30154087BACKGROUND
  • Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care Res (Hoboken). 2020 Feb;72(2):149-162. doi: 10.1002/acr.24131. Epub 2020 Jan 6.

    PMID: 31908149BACKGROUND
  • Lykkegaard J, Møller A and GH. Håndartrose blandt +70 årige i Almen Praksis, Denmark. [Hand Osteoarthritis among +70 year olds in General Practice, Denmark] Copenhagen; 2021.

    BACKGROUND
  • Bobos P, Nazari G, Szekeres M, Lalone EA, Ferreira L, MacDermid JC. The effectiveness of joint-protection programs on pain, hand function, and grip strength levels in patients with hand arthritis: A systematic review and meta-analysis. J Hand Ther. 2019 Apr-Jun;32(2):194-211. doi: 10.1016/j.jht.2018.09.012. Epub 2018 Dec 23.

    PMID: 30587434BACKGROUND
  • Takata SC, Wade ET, Roll SC. Hand therapy interventions, outcomes, and diagnoses evaluated over the last 10 years: A mapping review linking research to practice. J Hand Ther. 2019 Jan-Mar;32(1):1-9. doi: 10.1016/j.jht.2017.05.018. Epub 2017 Jun 21.

    PMID: 28647322BACKGROUND
  • Kjeken I, Smedslund G, Moe RH, Slatkowsky-Christensen B, Uhlig T, Hagen KB. Systematic review of design and effects of splints and exercise programs in hand osteoarthritis. Arthritis Care Res (Hoboken). 2011 Jun;63(6):834-48. doi: 10.1002/acr.20427.

    PMID: 21630479BACKGROUND
  • Osteras N, Kjeken I, Smedslund G, Moe RH, Slatkowsky-Christensen B, Uhlig T, Hagen KB. Exercise for hand osteoarthritis. Cochrane Database Syst Rev. 2017 Jan 31;1(1):CD010388. doi: 10.1002/14651858.CD010388.pub2.

    PMID: 28141914BACKGROUND
  • 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: 21834458BACKGROUND
  • 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: 15859525BACKGROUND
  • Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.

    PMID: 34593508BACKGROUND
  • O'Cathain A, Hoddinott P, Lewin S, Thomas KJ, Young B, Adamson J, Jansen YJ, Mills N, Moore G, Donovan JL. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers. Pilot Feasibility Stud. 2015 Sep 7;1:32. doi: 10.1186/s40814-015-0026-y. eCollection 2015.

    PMID: 27965810BACKGROUND
  • Fisher AG, Marterella A. Powerful practice: a Model for Authentic Occupational Therapy. Fisher AG, Marterella A, editors. Fort Collins, Colorado, USA: CIOTS - Center for innovative OT solutions..; 2019.

    BACKGROUND
  • Waehrens EE, Nielsen KT. ADL-Interview (ADL-I). Klinisk version 1.0 - Introduktion, ADL-I og administration [Clinical version 1.0 - Introduction, ADL-I, and administration]. Copenhagen; 2020.

    BACKGROUND
  • Waehrens EE, Bliddal H, Danneskiold-Samsoe B, Lund H, Fisher AG. Differences between questionnaire- and interview-based measures of activities of daily living (ADL) ability and their association with observed ADL ability in women with rheumatoid arthritis, knee osteoarthritis, and fibromyalgia. Scand J Rheumatol. 2012 Mar;41(2):95-102. doi: 10.3109/03009742.2011.632380. Epub 2012 Jan 30.

    PMID: 22283877BACKGROUND
  • Fisher AG, Jones KB. Assessment of motor and process skills : Volume 1: Development, standardization, and administration manual. 7. ed., Re. Fisher AG, Jones KB, editors. Fort Collins, Colo: Three Star Press; 2012.

    BACKGROUND
  • Fisher AG, Jones KB. Assessment of motor and process skills : Volume 2: User Manual. 7. ed. Fisher AG, Jones KB, editors. Fort Collins, Colo: Three Star Press; 2014.

    BACKGROUND
  • Waehrens EE. Measuring quality of occupational performance based on self-report and observation : development and validation of instruments to evaluate ADL task performance. Sweden, Umeå; 2010.

    BACKGROUND
  • Bard-Pondarre R, Villepinte C, Roumenoff F, Lebrault H, Bonnyaud C, Pradeau C, Bensmail D, Isner-Horobeti ME, Krasny-Pacini A. Goal Attainment Scaling in rehabilitation: An educational review providing a comprehensive didactical tool box for implementing Goal Attainment Scaling. J Rehabil Med. 2023 Jun 14;55:jrm6498. doi: 10.2340/jrm.v55.6498.

    PMID: 37317629BACKGROUND
  • Andersen U, Hagelskjaer V, von Bulow C, Gudbergsen H, Bliddal H, Dossing A, Waehrens EE. A multidisciplinary, cross-sectorial management program for people living with hand osteoarthritis (HANDY): protocol for a feasibility study. Pilot Feasibility Stud. 2025 May 15;11(1):68. doi: 10.1186/s40814-025-01653-1.

Study Officials

  • Eva Elisabet Ejlersen Wæhrens, PhD

    Parker Institute, Copenhagen University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulla Andersen, MScOT

CONTACT

Eva Elisabet Ejlersen Wæhrens, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Cohort design involving people with hand OA, general practitioners and occupational therapist employing a mixed-method approach
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2024

First Posted

February 12, 2024

Study Start

January 5, 2024

Primary Completion

May 3, 2024

Study Completion

June 28, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations