Digital Knee Osteoarthritis Mindset Intervention

NCT05698368 | Completed Results DMC

• 1 other identifier: 69227
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our clinical trial is to test if an online mindset intervention improves mindsets and physical activity levels more than an education intervention in individuals with knee osteoarthritis.

Conditions

Knee Osteoarthritis

Keywords

Mindset; Physical Activity; Exercise; Psychology; Pain; Digital Health; Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Knee Pain Measured by Numeric Pain Rating Scale

  Knee pain scored from 0 - 10 (0 being no pain and 10 being the worst pain)

  Change from Baseline at 1 month

• Change From Baseline in Physical Activity Measured by Physical Activity Scale for the Elderly

  The Physical Activity Scale for the Elderly (PASE) asks respondents about the frequency of light, moderate, and strenuous work and leisure activities and is a validated measure of self-reported physical activity for individuals with osteoarthritis. The scale is scored from 0 (no physical activity) to 793 (very high physical activity).

  Change from Baseline at 1 month

• Change From Baseline in Mindset About the Process of Health - Physical Activity (MPH-Physical Activity) Scale

  The Process of Health Mindset -- Exercise measure is a one-factor scale developed and validated to assess mindset about the process of engaging in physical activity (e.g., physical activity is difficult/easy, unpleasant/pleasurable, boring/fun). The scale consists of 7 items scored from 1 to 4, with a higher score reflecting a more appeal-focused mindset about physical activity, and then averaged for a total score between 1 to 4.

  Change from Baseline at Post-intervention (immediately following intervention completion)

• Change From Baseline in Osteoarthritis Mindset by the Illness Mindset Inventory

  The Illness Mindset Inventory measures three mindsets about the nature and meaning of illness: that it is a catastrophe, manageable, or an opportunity. The scale consists of 20 items measured on a 6-point scale and scored from 1 to 6, with 10 of those questions capturing mindsets about osteoarthritis. The extent to which a participant endorses a particular mindset can be obtained by calculating the mean score for each mindset. A higher score indicates greater agreement with the mindset. The investigators adapted the scale to focus on mindsets about "knee osteoarthritis" as opposed to "chronic disease." There are three subscales, Osteoarthritis is Castrophic, Osteoarthritis is Manageable, and Osteoarthritis is Opportunistic. The questions pertaining to each subscale are averaged for a total score from 1 to 6 for each subscale.

  Change from Baseline at Post-intervention (immediately following intervention completion)

Secondary Outcomes (9)

• Change From Baseline in Knee Pain and Functioning by the Short Version of Western Ontario and McMaster Universities Arthritis Index (shortMAC)

  Change from Baseline at 1 month

• Change From Baseline in Knee Osteoarthritis Knowledge by the Knee Osteoarthritis Knowledge Scale

  Change from Baseline at Post-intervention (immediately following intervention completion)

• Change From Baseline in Perceived Need for Surgery by a Surgery Perception Question

  Change from Baseline at 1 month

• Change From Baseline in Symptom Management Strategy by an Osteoarthritis Symptom Management Question. The Variable is Reported as a % of Participants Who Reported Using the Symptom Management Strategy.

  Change from Baseline at 1 month

• Change From Baseline in Fear of Movement by the Brief Fear of Movement Scale for Osteoarthritis

  Change from Baseline at 1 month

Study Arms (3)

Active comparator group

ACTIVE COMPARATOR

A series of educational videos and reflective questions of the same duration and required attention as the mindset intervention program. The videos are sourced videos from YouTube that educate about osteoarthritis. The content consists of information about osteoarthritis that patients would typically receive if looking for more information about the disease, including disease pathology, risks, symptoms, and treatment strategies. The included videos contain factual content with a similar format to the mindset intervention videos, including live experts sharing information with animations and supplementary b-roll footage.

Other: Active comparator

Mindset intervention group

EXPERIMENTAL

Four modules, each with a series of videos and reflective questions. Each module takes approximately 20-60 minutes to complete, with a total of about two hours to complete the entire program. Participants have one week to complete the program at their own pace. Participants are suggested to complete one module per day but are encouraged to go at the pace that works best for them.

Behavioral: Mindset intervention

Waitlist control group

NO INTERVENTION

This group will take the same surveys as the other groups at the same time points but will not receive any additional content.

Interventions

Mindset intervention BEHAVIORAL

Participants receive a digital mindset intervention to improve mindsets about osteoarthritis and exercise.

Mindset intervention group

Active comparator OTHER

Participants receive a series of osteoarthritis education videos and reflective questions that matches the digital mindset intervention in duration and attention.

Also known as: Educational content

Active comparator group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 45 years of age
• Self-reported doctor's diagnosis of knee osteoarthritis OR meets the National Institute for - - Health and Care Excellence osteoarthritis clinical criteria (activity-related knee pain and no knee morning stiffness lasting ≥ 30 minutes)
• Knee pain for at least 3 months
• Ability to walk unaided
• Can read and write in English
• Consistent internet access
• Willingness and ability to comply with the study requirements

You may not qualify if:

• Past total knee arthroplasty or scheduled surgical procedure on any back or lower limb with osteoarthritis within the next 12 months
• Recent serious injury (within the past 2 months) on the knee(s) with osteoarthritis
• Any condition making it unsafe to participate in physical activity
• Intra-articular therapy within the past 6 months (e.g. injections such as corticosteroids and hyaluronic acid)
• Participates in physical exercise for 30 minutes or more 5 days per week

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (20)

• Boswell MA, Evans KM, Zion SR, Boles DZ, Hicks JL, Delp SL, Crum AJ. Mindset is associated with future physical activity and management strategies in individuals with knee osteoarthritis. Ann Phys Rehabil Med. 2022 Nov;65(6):101634. doi: 10.1016/j.rehab.2022.101634. Epub 2022 Apr 28.

  PMID: 35091113 BACKGROUND

• Hinman RS, Campbell PK, Lawford BJ, Briggs AM, Gale J, Bills C, Kasza J, Harris A, French SD, Bunker SJ, Forbes A, Bennell KL. Does telephone-delivered exercise advice and support by physiotherapists improve pain and/or function in people with knee osteoarthritis? Telecare randomised controlled trial. Br J Sports Med. 2020 Jul;54(13):790-797. doi: 10.1136/bjsports-2019-101183. Epub 2019 Nov 20.

  PMID: 31748198 BACKGROUND

• Crum AJ, Salovey P, Achor S. Rethinking stress: the role of mindsets in determining the stress response. J Pers Soc Psychol. 2013 Apr;104(4):716-33. doi: 10.1037/a0031201. Epub 2013 Feb 25.

  PMID: 23437923 BACKGROUND

• Gay C, Guiguet-Auclair C, Mourgues C, Gerbaud L, Coudeyre E. Physical activity level and association with behavioral factors in knee osteoarthritis. Ann Phys Rehabil Med. 2019 Jan;62(1):14-20. doi: 10.1016/j.rehab.2018.09.005. Epub 2018 Oct 2.

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• Fransen M, McConnell S. Exercise for osteoarthritis of the knee. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD004376. doi: 10.1002/14651858.CD004376.pub2.

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• Marks R. Knee osteoarthritis and exercise adherence: a review. Curr Aging Sci. 2012 Feb;5(1):72-83. doi: 10.2174/1874609811205010072.

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• Hunter DJ, March L, Chew M. Osteoarthritis in 2020 and beyond: a Lancet Commission. Lancet. 2020 Nov 28;396(10264):1711-1712. doi: 10.1016/S0140-6736(20)32230-3. Epub 2020 Nov 4. No abstract available.

  PMID: 33159851 BACKGROUND

• Stanton TR, Karran EL, Butler DS, Hull MJ, Schwetlik SN, Braithwaite FA, Jones HG, Moseley GL, Hill CL, Tomkins-Lane C, Maher C, Bennell K. A pain science education and walking program to increase physical activity in people with symptomatic knee osteoarthritis: a feasibility study. Pain Rep. 2020 Sep 24;5(5):e830. doi: 10.1097/PR9.0000000000000830. eCollection 2020 Sep-Oct.

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• Thorstensson CA, Garellick G, Rystedt H, Dahlberg LE. Better Management of Patients with Osteoarthritis: Development and Nationwide Implementation of an Evidence-Based Supported Osteoarthritis Self-Management Programme. Musculoskeletal Care. 2015 Jun;13(2):67-75. doi: 10.1002/msc.1085. Epub 2014 Oct 24.

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• Pisters MF, Veenhof C, Schellevis FG, De Bakker DH, Dekker J. Long-term effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized controlled trial comparing two different physical therapy interventions. Osteoarthritis Cartilage. 2010 Aug;18(8):1019-26. doi: 10.1016/j.joca.2010.05.008. Epub 2010 May 19.

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• Skou ST, Koes BW, Gronne DT, Young J, Roos EM. Comparison of three sets of clinical classification criteria for knee osteoarthritis: a cross-sectional study of 13,459 patients treated in primary care. Osteoarthritis Cartilage. 2020 Feb;28(2):167-172. doi: 10.1016/j.joca.2019.09.003. Epub 2019 Sep 17.

  PMID: 31539621 BACKGROUND

• Boles DZ, DeSousa M, Turnwald BP, Horii RI, Duarte T, Zahrt OH, Markus HR, Crum AJ. Can Exercising and Eating Healthy Be Fun and Indulgent Instead of Boring and Depriving? Targeting Mindsets About the Process of Engaging in Healthy Behaviors. Front Psychol. 2021 Oct 5;12:745950. doi: 10.3389/fpsyg.2021.745950. eCollection 2021.

  PMID: 34712186 BACKGROUND

• Washburn RA, Smith KW, Jette AM, Janney CA. The Physical Activity Scale for the Elderly (PASE): development and evaluation. J Clin Epidemiol. 1993 Feb;46(2):153-62. doi: 10.1016/0895-4356(93)90053-4.

  PMID: 8437031 BACKGROUND

• Abbott JH, Hobbs C, Gwynne-Jones D; MOA Trial Team. The ShortMAC: Minimum Important Change of a Reduced Version of the Western Ontario and McMaster Universities Osteoarthritis Index. J Orthop Sports Phys Ther. 2018 Feb;48(2):81-86. doi: 10.2519/jospt.2018.7676. Epub 2017 Oct 21.

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• Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.

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• Darlow B, Abbott H, Bennell K, Briggs AM, Brown M, Clark J, Dean S, French S, Hinman RS, Krageloh C, Metcalf B, O'Brien D, Stanley J, Whittaker JL. Knowledge about osteoarthritis: Development of the Hip and Knee Osteoarthritis Knowledge Scales and protocol for testing their measurement properties. Osteoarthr Cartil Open. 2021 Apr 9;3(2):100160. doi: 10.1016/j.ocarto.2021.100160. eCollection 2021 Jun.

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• Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.

  PMID: 20685078 BACKGROUND

• Shelby RA, Somers TJ, Keefe FJ, DeVellis BM, Patterson C, Renner JB, Jordan JM. Brief Fear of Movement Scale for osteoarthritis. Arthritis Care Res (Hoboken). 2012 Jun;64(6):862-71. doi: 10.1002/acr.21626. Epub 2012 Jan 30.

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  PMID: 2912463 BACKGROUND

• Boswell MA, Evans KM, Ghandwani D, Hastie T, Zion SR, Moya PL, Giori NJ, Hicks JL, Crum AJ, Delp SL. A randomized clinical trial testing digital mindset intervention for knee osteoarthritis pain and activity improvement. NPJ Digit Med. 2024 Oct 17;7(1):285. doi: 10.1038/s41746-024-01281-8.

  PMID: 39414999 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity; Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Melissa Boswell
• Organization: Stanford University

boswellm@stanford.edu

(650) 725-4009

Study Officials

• Melissa Boswell, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Scott Delp, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Alia Crum, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blind investigator and outcomes assessor: does not know group label
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Investigator

Model Details: Participants are randomly assigned to one of three groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: January 26, 2023
• Study Start: April 10, 2023
• Primary Completion: September 19, 2023
• Study Completion: September 19, 2023
• Last Updated: February 13, 2025
• Results First Posted: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Upon manuscript submission
• Access Criteria: Open-source

Locations

US (1)