scholarly journals Moderators of the Effect of a Self-directed Digitally Delivered Exercise Program for People With Knee Osteoarthritis: Exploratory Analysis of a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Rachel K Nelligan ◽  
Rana S Hinman ◽  
Fiona McManus ◽  
Karen E Lamb ◽  
Kim L Bennell
Keyword(s):  
Self Efficacy ◽  
Controlled Trial ◽  
Patient Characteristics ◽  
Web Based ◽  
Knee Oa ◽  
Randomized Controlled ◽  
Unit Increase ◽  
Baseline Characteristics ◽  
And Function ◽  
Web Based Education

BACKGROUND A 24-week self-directed digitally delivered intervention was found to improve pain and function in people with knee osteoarthritis (OA). However, it is possible that this intervention may be better suited to certain subgroups of people with knee OA compared to others. OBJECTIVE The aim of this study was to explore whether certain individual baseline characteristics moderate the effects of a self-directed digitally delivered intervention on changes in pain and function over 24 weeks in people with knee OA. METHODS An exploratory analysis was conducted on data from a randomized controlled trial involving 206 people with a clinical diagnosis of knee OA. This trial compared a self-directed digitally delivered intervention comprising of web-based education, exercise, and physical activity program supported by automated exercise behavior change mobile phone text messages to web-based education alone (control). The primary outcomes were changes in overall knee pain (assessed on an 11-point numerical rating scale) and physical function (assessed using the Western Ontario and McMaster Universities Osteoarthritis Index function subscale [WOMAC]) at 24 weeks. Five baseline patient characteristics were selected as the potential moderators: (1) number of comorbidities, (2) number of other painful joints, (3) pain self-efficacy, (4) exercise self-efficacy, and (5) self-perceived importance of exercise. Separate linear regression models for each primary outcome and each potential moderator were fit, including treatment group, moderator, and interaction between treatment group and moderator, adjusting for the outcome at baseline. RESULTS There was evidence that pain self-efficacy moderated the effect of the intervention on physical function compared to the control at 24 weeks (interaction <i>P</i>=.02). Posthoc assessment of the mean change in WOMAC function by treatment arm showed that each 1-unit increase in baseline pain self-efficacy was associated with a 1.52 (95% CI 0.27 to 2.78) unit improvement in the control group. In contrast, a reduction of 0.62 (95% CI –1.93 to 0.68) units was observed in the intervention group with each unit increase in pain self-efficacy. There was only weak evidence that pain self-efficacy moderated the effect of the intervention on pain and that number of comorbidities, number of other painful joints, exercise self-efficacy, or exercise importance moderated the effect of the intervention on pain or function. CONCLUSIONS With the exception of pain self-efficacy, which moderated changes in function but not pain, we found limited evidence that our selected baseline patient characteristics moderated intervention outcomes. This indicates that people with a range of baseline characteristics respond similarly to the unsupervised digitally delivered exercise intervention. As these findings are exploratory in nature, they require confirmation in future studies.

scholarly journals Moderators of the Effect of a Self-directed Digitally Delivered Exercise Program for People With Knee Osteoarthritis: Exploratory Analysis of a Randomized Controlled Trial

10.2196/30768 ◽  
2021 ◽  
Vol 23 (10) ◽  
pp. e30768
Author(s):  
Rachel K Nelligan ◽  
Rana S Hinman ◽  
Fiona McManus ◽  
Karen E Lamb ◽  
Kim L Bennell
Keyword(s):  
Self Efficacy ◽  
Controlled Trial ◽  
Patient Characteristics ◽  
Web Based ◽  
Knee Oa ◽  
Randomized Controlled ◽  
Unit Increase ◽  
Baseline Characteristics ◽  
And Function ◽  
Web Based Education

Background A 24-week self-directed digitally delivered intervention was found to improve pain and function in people with knee osteoarthritis (OA). However, it is possible that this intervention may be better suited to certain subgroups of people with knee OA compared to others. Objective The aim of this study was to explore whether certain individual baseline characteristics moderate the effects of a self-directed digitally delivered intervention on changes in pain and function over 24 weeks in people with knee OA. Methods An exploratory analysis was conducted on data from a randomized controlled trial involving 206 people with a clinical diagnosis of knee OA. This trial compared a self-directed digitally delivered intervention comprising of web-based education, exercise, and physical activity program supported by automated exercise behavior change mobile phone text messages to web-based education alone (control). The primary outcomes were changes in overall knee pain (assessed on an 11-point numerical rating scale) and physical function (assessed using the Western Ontario and McMaster Universities Osteoarthritis Index function subscale [WOMAC]) at 24 weeks. Five baseline patient characteristics were selected as the potential moderators: (1) number of comorbidities, (2) number of other painful joints, (3) pain self-efficacy, (4) exercise self-efficacy, and (5) self-perceived importance of exercise. Separate linear regression models for each primary outcome and each potential moderator were fit, including treatment group, moderator, and interaction between treatment group and moderator, adjusting for the outcome at baseline. Results There was evidence that pain self-efficacy moderated the effect of the intervention on physical function compared to the control at 24 weeks (interaction P=.02). Posthoc assessment of the mean change in WOMAC function by treatment arm showed that each 1-unit increase in baseline pain self-efficacy was associated with a 1.52 (95% CI 0.27 to 2.78) unit improvement in the control group. In contrast, a reduction of 0.62 (95% CI –1.93 to 0.68) units was observed in the intervention group with each unit increase in pain self-efficacy. There was only weak evidence that pain self-efficacy moderated the effect of the intervention on pain and that number of comorbidities, number of other painful joints, exercise self-efficacy, or exercise importance moderated the effect of the intervention on pain or function. Conclusions With the exception of pain self-efficacy, which moderated changes in function but not pain, we found limited evidence that our selected baseline patient characteristics moderated intervention outcomes. This indicates that people with a range of baseline characteristics respond similarly to the unsupervised digitally delivered exercise intervention. As these findings are exploratory in nature, they require confirmation in future studies.

scholarly journals Long-Term Smoking Cessation Outcomes for Sexual Minority Versus Nonminority Smokers in a Large Randomized Controlled Trial of Two Web-Based Interventions

2019 ◽  
Vol 22 (9) ◽  
pp. 1596-1604
Author(s):  
Jaimee L Heffner ◽  
Kristin E Mull ◽  
Noreen L Watson ◽  
Jennifer B McClure ◽  
Jonathan B Bricker
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Treatment Outcomes ◽  
Sexual Minority ◽  
Controlled Trial ◽  
Web Based ◽  
Psychosocial Profile ◽  
Randomized Controlled ◽  
Quit Smoking ◽  
Baseline Characteristics

Abstract Introduction Despite greater smoking prevalence among sexual minority (SM) individuals relative to non-SM individuals, minimal research has examined whether SM smokers have differential success at quitting, and no prior treatment studies have examined differences within SM subgroups. There is also limited knowledge of the psychosocial characteristics of treatment-seeking SM smokers, which could inform targeted treatments. To address these gaps, we compared treatment outcomes and baseline characteristics for SM and non-SM smokers and for bisexual versus lesbian or gay smokers in a large randomized controlled trial of two web-based cessation treatments. Methods Trial participants completed a survey to assess baseline characteristics, including self-identification as either SM (n = 253; lesbian or gay, n = 122; bisexual, n = 131) or non-SM (n = 2384). The primary cessation outcome was complete-case, self-reported 30-day abstinence at 12 months after randomization. Results Cessation outcomes did not differ significantly for SM versus non-SM smokers (24% vs. 25%, adjusted OR = 0.91, 95% CI = 0.65 to 1.28) or across SM subgroups (24% for bisexual vs. 23% for lesbian or gay, adjusted OR = 1.01, 95% CI = 0.51 to 2.00), and there were no interactions with treatment group assignment. At baseline, SM smokers differed from non-SM smokers on most demographics, were more likely to screen positive for all mental health conditions assessed, and had greater exposure to other smokers in the home. Conclusions Substantial differences in baseline characteristics of SM versus non-SM smokers and bisexual versus lesbian or gay smokers did not translate into differential treatment outcomes. Nonetheless, SM smokers’ willingness or ability to quit smoking could be enhanced by taking their unique psychosocial profile into account when designing targeted interventions. Implications The findings of this study, which included the largest sample of SM smokers in a prospective intervention trial to date, support those of a small extant body of literature showing no differences in treatment-assisted cessation outcomes between SM and non-SM smokers. Regardless of their quit rates relative to non-SM smokers, SM smokers’ willingness or ability to quit smoking could potentially be enhanced by taking their unique psychosocial profile into account in intervention design, including their younger age, lower socioeconomic status, greater likelihood of being racial or ethnic minorities, and greater prevalence of mental health symptoms.

scholarly journals Effectiveness of combined chain exercises on pain and function in patients with knee osteoarthritis

2016 ◽  
Vol 15 (2) ◽  
pp. 178-188 ◽  
Author(s):  
Oladapo Michael Olagbegi ◽  
Babatunde Olusola Adeleke Adegoke ◽  
Adesola C Odole
Keyword(s):  
Controlled Trial ◽  
Medical Science ◽  
Hip Osteoarthritis ◽  
Kinetic Chain ◽  
Knee Oa ◽  
Randomized Controlled ◽  
Dependent Variables ◽  
Before And After ◽  
And Function ◽  
Better Than

Objective: This randomized controlled trial was designed to investigate and compare the effectiveness of twelve-week open, closed and combined kinetic-chain exercises (OKCEs, CKCEs and CCEs) on pain and physical function (PF) in the management of knee osteoarthritis.Method: Ninety-six consecutive patients with knee OA were randomly assigned to one of OKCE, CKCE and CCE groups. Participants’ average daily pain (ADP), pain before and after walking (PBW and PAW), were evaluated using Visual Analogue Scale while PF was assessed using Ibadan Knee/Hip Osteoarthritis Outcome Measure.Results: Seventy-nine participants completed the study but data of another 4 participants who completed only 8-week treatment were included in data analysis (total=83; mean age = 61.10±13.75 years). The groups’ demographic and dependent variables were comparable at baseline but CCE group demonstrated significantly more reductions (p < 0.05) in ADP, PBW and PAW than OKCE and CKCE groups at weeks 4, 8 and 12 of the study. However, there were significant within group improvements (p < 0.05) in all four variables for the three groups. Conclusion: CCEs are better than OKCEs and CKCEs for pain reduction in though all three exercise regimens are singly effective. CCEs are recommended for improving treatment outcome for pain in patients with knee osteoarthritis.Bangladesh Journal of Medical Science Vol.15(2) 2016 p.178-188

scholarly journals Effectiveness of the Fun for Wellness Web-Based Behavioral Intervention to Promote Physical Activity in Adults With Obesity (or Overweight): Randomized Controlled Trial

10.2196/15919 ◽  
2020 ◽  
Vol 4 (2) ◽  
pp. e15919 ◽  
Author(s):  
Nicholas D Myers ◽  
Adam McMahon ◽  
Isaac Prilleltensky ◽  
Seungmin Lee ◽  
Samantha Dietz ◽  
...  
Keyword(s):  
Physical Activity ◽  
Direct Effect ◽  
Behavioral Intervention ◽  
Self Efficacy ◽  
Controlled Trial ◽  
The United States ◽  
Web Based ◽  
Randomized Controlled ◽  
Global Pandemic ◽  
Insufficient Physical Activity

Background Insufficient physical activity in the adult population is a global pandemic. Fun for Wellness (FFW) is a self-efficacy theory- and Web-based behavioral intervention developed to promote growth in well-being and physical activity by providing capability-enhancing opportunities to participants. Objective This study aimed to evaluate the effectiveness of FFW to increase physical activity in adults with obesity in the United States in a relatively uncontrolled setting. Methods This was a large-scale, prospective, double-blind, parallel-group randomized controlled trial. Participants were recruited through an online panel recruitment company. Adults with overweight were also eligible to participate, consistent with many physical activity–promoting interventions for adults with obesity. Also consistent with much of the relevant literature the intended population as simply adults with obesity. Eligible participants were randomly assigned to the intervention (ie, FFW) or the usual care (ie, UC) group via software code that was written to accomplish equal allocations to the FFW and UC groups. Data collection was Web based, fully automated, and occurred at three time points: baseline, 30 days after baseline (T2), and 60 days after baseline (T3). Participants (N=461) who were assigned to the FFW group (nFFW=219) were provided with 30 days of 24-hour access to the Web-based intervention. A path model was fit to the data consistent with the FFW conceptual model for the promotion of physical activity. Results There was evidence for a positive direct effect of FFW on transport-related physical activity self-efficacy (beta=.22, P=.02; d=0.23), domestic-related physical activity self-efficacy (beta=.22, P=.03; d=0.22), and self-efficacy to regulate physical activity (beta=.16, P=.01; d=0.25) at T2. Furthermore, there was evidence for a positive indirect effect of FFW on physical activity at T3 through self-efficacy to regulate physical activity at T2 (beta=.42, 95% CI 0.06 to 1.14). Finally, there was evidence for a null direct effect of FFW on physical activity (beta=1.04, P=.47; d=0.07) at T3. Conclusions This study provides some initial evidence for both the effectiveness (eg, a positive indirect effect of FFW on physical activity through self-efficacy to regulate physical activity) and the ineffectiveness (eg, a null direct effect of FFW on physical activity) of the FFW Web-based behavioral intervention to increase physical activity in adults with obesity in the United States. More broadly, FFW is a scalable Web-based behavioral intervention that may effectively, although indirectly, promote physical activity in adults with obesity and therefore may be useful in responding to the global pandemic of insufficient physical activity in this at-risk population. Self-efficacy to regulate physical activity appears to be a mechanism by which FFW may indirectly promote physical activity in adults with obesity. Trial Registration ClinicalTrials.gov, identifier: NCT03194854; https://clinicaltrials.gov/ct2/show/NCT03194854.

scholarly journals Efficacy of a Web-Based Self-Management Enhancing Program for Patients with Rheumatoid Arthritis: Explorative Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Rixt Zuidema ◽  
Sandra van Dulmen ◽  
Maria Nijhuis-van der Sanden ◽  
Inger Meek ◽  
Cornelia van den Ende ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Randomized Controlled Trial ◽  
Outcome Measures ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Management ◽  
Web Based ◽  
Positive Effects ◽  
Randomized Controlled

BACKGROUND Web-based self-management enhancing programs have the potential to support patients with rheumatoid arthritis (RA) in their self-management; for example, improve their health status by increasing their self-efficacy or taking their prescribed medication. We developed a Web-based self-management enhancing program in collaboration with RA patients and professionals as co-designers on the basis of the intervention mapping framework. Although self-management programs are complex interventions, it is informative to perform an explorative randomized controlled trial (RCT) before embarking on a larger trial. OBJECTIVE This study aimed to evaluate the efficacy of a Web-based self-management enhancing program for patients with RA and identify outcome measures most likely to capture potential benefits. METHODS A multicenter exploratory RCT was performed with an intervention group and a control group. Both groups received care as usual. In addition, the intervention group received 12 months of access to a Web-based self-management program. Assessment occurred at baseline, 6 months, and 12 months. Outcome measures included self-management behavior (Patient Activation Measurement, Self-Management Ability Scale), self-efficacy (Rheumatoid Arthritis task-specific Self-Efficacy, Perceived Efficacy in Patient-Physician Interaction), general health status (RAND-36), focus on fatigue (Modified Pain Coping Inventory for Fatigue), and perceived pain and fatigue (Numeric Rating Scales). A linear mixed model for repeated measures, using the intention-to-treat principle, was applied to study differences between the patients in the intervention (n=78) and control (n=79) groups. A sensitivity analysis was performed in the intervention group to study the influence of patients with high (N=30) and low (N=40) use of the intervention. RESULTS No positive effects were found regarding the outcome measurements. Effect sizes were low. CONCLUSIONS Based on these results, it is not possible to conclude on the positive effects of the intervention or to select outcome measures to be regarded as the primary/main or secondary outcomes for a future trial. A process evaluation should be performed to provide more insight into the low compliance with and effectiveness of the intervention. This can determine for whom this sort of program will work and help to fine-tune the inclusion criteria. CLINICALTRIAL Netherlands Trial Register NTR4871; https://www.trialregister.nl/trial/4726

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