Digital Knee Osteoarthritis Mindset Intervention

Knee Osteoarthritis Clinical Trial

Official title:

A Digital Mindset Intervention to Improve Pain and Exercise Participation in Individuals With Knee Osteoarthritis: A Randomized, Parallel-group Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05698368
• Other study ID #: 69227
• Status: Completed
• Phase: N/A
• Start date: April 10, 2023
• Est. completion date: September 19, 2023

Study information

• Verified date: September 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Osteoarthritis affects 7% of the global population and is a leading cause of disability globally. Physical activity improves health outcomes, weight management, and knee function for people with knee osteoarthritis and should be considered first-line treatment. Yet, physical activity levels in this population are low compared to those without knee osteoarthritis. Existing knowledge: Emerging research has highlighted the powerful influence of mindsets about exercise on engagement in physical activity. Mindsets are core assumptions about a domain or category that orient individuals to a particular set of attributions, expectations, and goals (a "meaning system"). In individuals with knee osteoarthritis, mindsets about the appeal of physical activity relate to future physical activity levels and one's chosen symptom management strategy, and mindsets about osteoarthritis relate to knee symptoms. The investigators developed a digital mindset intervention to improve mindsets about exercise and osteoarthritis in individuals with knee osteoarthritis. The investigators piloted the intervention on 21 individuals with knee osteoarthritis throughout the United States. Participants improved in exercise and osteoarthritis mindsets. However, this was a small sample size, a control group was not used, and it was cross-sectional, thus, not able to evaluate changes in physical activity and osteoarthritis symptoms. Need for a trial: A digital, low-cost, and, thus, scalable intervention to improve mindsets about osteoarthritis and exercise may improve pain and function and physical activity levels for the millions of individuals affected with knee osteoarthritis. A large randomized trial is therefore needed to evaluate if our mindset intervention leads to improvements in physical activity levels and osteoarthritis symptoms and, further, if these changes are due to more adaptive mindsets about exercise and osteoarthritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 527
• Est. completion date: September 19, 2023
• Est. primary completion date: September 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion criteria:

• 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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Mindset intervention
Participants receive a digital mindset intervention to improve mindsets about osteoarthritis and exercise.

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

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (19)

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989 Jan;32(1):37-44. doi: 10.1002/anr.1780320107. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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 to over 400 with higher scores indicating higher levels of physical activity.	Change from Baseline at 1 month
Primary	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 measured on a 4-point scale and scored from 1 to 4, with a higher score reflecting a more appeal-focused mindset about physical activity.	Change from Baseline at Post-intervention (immediately following intervention completion)
Primary	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."	Change from Baseline at Post-intervention (immediately following intervention completion)
Secondary	Change from baseline in knee pain and functioning by the Short version of Western Ontario and McMaster Universities Arthritis Index (shortMAC)	The short-version of the Western Ontario and McMaster Universities Osteoarthritis Index (ShortMAC) is a disease-specific 12-item measure of knee pain, stiffness, and function. It has been validated and shown to be reliable in patients with knee osteoarthritis. It is measured on the Likert scale and can be divided into two subscales: pain and function.	Change from Baseline at 1 month
Secondary	Change from baseline in knee osteoarthritis knowledge by the Knee Osteoarthritis Knowledge Scale	The Knee Osteoarthritis Knowledge Scale is scored from 11-55 and measures knowledge about osteoarthritis in individuals with knee or hip osteoarthritis.	Change from Baseline at Post-intervention (immediately following intervention completion)
Secondary	Change from baseline in perceived need for surgery by a surgery perception question	Perceived need for surgery will be assessed by the single question, "How likely do you think you are of needing knee replacement surgery in the future?" It is answered on the Likert scale from 1 (very unlikely) to 5 (very likely)	Change from Baseline at 1 month
Secondary	Change from baseline in symptom management strategy by an osteoarthritis symptom management question	Chosen symptom management strategy(ies) will be assessed by the single question, "Which of the following are ways in which you manage and/or improve your osteoarthritis symptoms? Please select all that apply." It is answer via multiple choice with multiple selection option. The options available are the most common strategies as determined by previous studies with an additional option for fill in.	Change from Baseline at 1 month
Secondary	Change from baseline in fear of movement by the Brief Fear of Movement Scale for Osteoarthritis	The Brief Fear of Movement Scale for Osteoarthritis is a 6-item scale validated to assess fear of movement in individuals with osteoarthritis.	Change from Baseline at 1 month
Secondary	Change from baseline in arthritis self-efficacy: pain and other symptoms by the Arthritis self-efficacy pain and other symptoms subscales	The Arthritis-Self Efficacy Scale is scored from a 1 to 10 with higher scores indicating greater self-efficacy. The scale will be divided into the "pain" and "other symptoms" subscales.	Change from Baseline at 1 month
Secondary	Change from baseline in physical and mental health: Global Health: Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 - Global Health (Physical and mental health sub-scales)	The PROMIS v.1.1 Global Health Short Form is a 10-item survey that measures overall physical function, fatigue, pain, emotional distress, and social health in healthy and clinical adult populations. It will be divided into two sub-scales: physical health and mental health.	Change from Baseline at 1 month
Secondary	Change from baseline in body mindset by the Illness Mindset Inventory	The Illness Mindset Inventory measures three mindsets about the nature of the body in the context of a chronic illness: that it is adversarial, responsive, or resilient. 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 the body. 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."	Change from Baseline at Post-intervention (immediately following intervention completion)
Secondary	Change from baseline in self-fulfilling meta-mindset by the Self-fulfilling Meta-Mindset Scale	The Self-fulfilling Meta-Mindset Scale is a 4-item survey that measures the extent to which one believes that having a mindset about something might change its outcome.	Change from Baseline at Post-intervention (immediately following intervention completion)
Secondary	Change from baseline in controllable meta-mindset by the Controllable Meta-Mindset Scale	The Controllable Meta-Mindset Scale is a 4-item survey that measures one's beliefs about your ability to change and control their mindsets.	Change from Baseline at Post-intervention (immediately following intervention completion)
Secondary	Change from baseline in adequacy mindset by the Adequacy of Activity Mindset Measure	The Adequacy of Activity Mindset Measure is a scale developed to assess mindsets about the adequacy and benefits of ones' physical activity as it relates to health. The scale consists of 5 items measured on a 7-point scale and scored from 1 to 7, with a higher score reflecting a more adaptive mindset about the benefits and risks associated with current levels of physical activity.	Change from Baseline at Post-intervention (immediately following intervention completion)