scholarly journals Effects of a 12-Week Digital Care Program for Chronic Knee Pain on Pain, Mobility, and Surgery Risk: Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Gabriel Mecklenburg ◽  
Peter Smittenaar ◽  
Jennifer C Erhart-Hledik ◽  
Daniel A Perez ◽  
Simon Hunter
Keyword(s):  
Randomized Controlled Trial ◽  
Physical Function ◽  
Knee Pain ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Care Program ◽  
Control Group ◽  
Randomized Controlled ◽  
Chronic Knee Pain ◽  
Secondary Outcomes

BACKGROUND Chronic knee pain, most commonly caused by knee osteoarthritis, is a prevalent condition which in most cases can be effectively treated through conservative, non-surgical care involving exercise therapy, education, psychosocial support, and weight loss. However, most people living with chronic knee pain do not receive adequate care, leading to unnecessary use of opiates and surgical procedures. OBJECTIVE Assess the efficacy of a remotely delivered digital care program for chronic knee pain. METHODS We enrolled 162 participants into a randomized controlled trial between January and March 2017. Participants were recruited from participating employers using questionnaires for self-assessment of their knee pain, and randomized into treatment (n=101) and control (n=61) groups. Participants in the treatment group were enrolled in the Hinge Health digital care program for chronic knee pain. This is a remotely delivered, home-based 12-week intervention that includes sensor-guided exercise therapy, education, cognitive behavioral therapy, weight loss, and psychosocial support through a personal coach and team-based interactions. The control group received three education pieces regarding self-care for chronic knee pain. Both groups had access to treatment-as-usual. The primary outcome was the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale and KOOS Physical Function Shortform (KOOS-PS). Secondary outcomes were visual analog scales (VAS) for pain and stiffness respectively, surgery intent, and self-reported understanding of the condition and treatment options. Outcome measures were analyzed by intention to treat (excluding 7 control participants who received the digital care program due to administrative error) and per protocol. RESULTS In an intent-to-treat analysis the digital care program group had a significantly greater reduction in KOOS Pain compared to the control group at the end of the program (greater reduction of 7.7, 95% CI 3.0 to 12.3, P=.002), as well as a significantly greater improvement in physical function (7.2, 95% CI 3.0 to 11.5, P=.001). This was also reflected in the secondary outcomes VAS pain (12.3, 95% CI 5.4 to 19.1, P<.001) and VAS stiffness (13.4, 95% CI 5.6 to 21.1, P=.001). Participants’ self-reported likelihood (from 0% to 100%) of having surgery also reduced more strongly in the digital care program group compared to the control group over the next 1 year (–9.4 percentage points, pp, 95% CI –16.6 to –2.2, P=.01), 2 years (–11.3 pp, 95% CI –20.1 to –2.5, P=.01), and 5 years (–14.6 pp, 95% CI –23.6 to –5.5, P=.002). Interest in surgery (from 0 to 10) also reduced more so in the digital care program compared to control group (–1.0, 95% CI –1.7 to –0.2, P=.01). Participants’ understanding of the condition and treatment options (on a scale from 0 to 4) increased more substantially for participants in the digital care program than those in the control group (0.9, 95% CI 0.6 to 1.3, P<.001). In an analysis on participants that completed the intervention (per protocol analysis) all primary and secondary outcomes remained significant at greater effect magnitudes compared to intention to treat, with those completing the program showing a 61% (95% CI 48 to 74) reduction in VAS pain compared to 21% (95% CI 5 to 38) in the control group (P<.001). Accounting for the cost of administering the program, we estimate net cost savings on surgery alone of US $4340 over 1 year and $7900 over 5 years for those participants completing the digital care program compared to those in the control group receiving treatment-as-usual. In an exploratory subgroup analysis including only participants exhibiting clinical symptoms of osteoarthritis the program proved equally effective. CONCLUSIONS This trial provides strong evidence that a comprehensive 12-week digital care program for chronic knee pain, including osteoarthritis, yields significantly improved outcomes for pain, physical function, stiffness, surgery risk, and understanding of the condition, compared to a control group. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 13307390; http://www.isrctn.com/ISRCTN13307390 (Archived by WebCite at http://www.webcitation.org/6ycwjGL73)

scholarly journals Effects of a 12-Week Digital Care Program for Chronic Knee Pain on Pain, Mobility, and Surgery Risk: Randomized Controlled Trial

2018 ◽  
Vol 20 (4) ◽  
pp. e156 ◽  
Author(s):  
Gabriel Mecklenburg ◽  
Peter Smittenaar ◽  
Jennifer C Erhart-Hledik ◽  
Daniel A Perez ◽  
Simon Hunter
Keyword(s):  
Randomized Controlled Trial ◽  
Knee Pain ◽  
Controlled Trial ◽  
Care Program ◽  
Randomized Controlled ◽  
Chronic Knee Pain

scholarly journals Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Vol 18 (6) ◽  
pp. 3097
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

scholarly journals A randomized controlled trial on a self-guided Internet-based intervention for gambling problems

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Lara Bücker ◽  
Josefine Gehlenborg ◽  
Steffen Moritz ◽  
Stefan Westermann
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Group Differences ◽  
Control Group ◽  
Gambling Problems ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Internet Based Intervention

AbstractThe majority of individuals with problematic and pathological gambling remain untreated, and treatment barriers are high. Internet-based interventions can help to address existing barriers, and first studies suggest their potential for this target group. Within a randomized controlled trial (N = 150) with two assessment times (baseline and post-intervention), we aimed to investigate the feasibility, acceptance, and effectiveness of a self-guided Internet-based intervention targeted at gambling problems. We expected a significant reduction in gambling symptoms (primary outcome) and depressive symptoms as well gambling-specific dysfunctional thoughts (secondary outcomes) in the intervention group (IG) compared to a wait-list control group with access to treatment-as-usual (control group, CG) after the intervention period of 8 weeks. Results of the complete cases, per protocol, intention-to-treat (ITT), and frequent user analyses showed significant improvements in both groups for primary and secondary outcomes but no significant between-group differences (ITT primary outcome, F(1,147) = .11, p = .739, ηp2 < .001). Moderation analyses indicated that individuals in the IG with higher gambling and depressive symptoms, older age, and comorbid anxiety symptoms showed significant improvement relative to the CG. The intervention was positively evaluated (e.g., 96.5% rated the program as useful). Possible reasons for the nonsignificant between-group differences are discussed. Future studies should include follow-up assessments and larger samples to address limitations of the present study. Trial Registration ClinicalTrials.gov (NCT03372226), http://clinicaltrials.gov/ct2/show/NCT03372226, date of registration (13/12/2017).

scholarly journals The Effects of Telemonitoring on Patient Compliance With Self-Management Recommendations and Outcomes of the Innovative Telemonitoring Enhanced Care Program for Chronic Heart Failure: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Hang Ding ◽  
Rajiv Jayasena ◽  
Sheau Huey Chen ◽  
Andrew Maiorana ◽  
Alison Dowling ◽  
...  
Keyword(s):  
Heart Failure ◽  
Randomized Controlled Trial ◽  
Chronic Heart Failure ◽  
Patient Compliance ◽  
Controlled Trial ◽  
Care Program ◽  
Self Management ◽  
Control Group ◽  
Randomized Controlled ◽  
Management Recommendations

BACKGROUND Telemonitoring enables care providers to remotely support outpatients in self-managing chronic heart failure (CHF), but the objective assessment of patient compliance with self-management recommendations has seldom been studied. OBJECTIVE This study aimed to evaluate patient compliance with self-management recommendations of an innovative telemonitoring enhanced care program for CHF (ITEC-CHF). METHODS We conducted a multicenter randomized controlled trial with a 6-month follow-up. The ITEC-CHF program comprised the provision of Bluetooth-enabled scales linked to a call center and nurse care services to assist participants with weight monitoring compliance. Compliance was defined a priori as weighing at least 4 days per week, analyzed objectively from weight recordings on the scales. The intention-to-treat principle was used to perform the analysis. RESULTS A total of 184 participants (141/184, 76.6% male), with a mean age of 70.1 (SD 12.3) years, were randomized to receive either ITEC-CHF (n=91) or usual care (control; n=93), of which 67 ITEC-CHF and 81 control participants completed the intervention. For the compliance criterion of weighing at least 4 days per week, the proportion of compliant participants in the ITEC-CHF group was not significantly higher than that in the control group (ITEC-CHF: 67/91, 74% vs control: 56/91, 60%; <i>P</i>=.06). However, the proportion of ITEC-CHF participants achieving the stricter compliance standard of at least 6 days a week was significantly higher than that in the control group (ITEC-CHF: 41/91, 45% vs control: 23/93, 25%; <i>P</i>=.005). CONCLUSIONS ITEC-CHF improved participant compliance with weight monitoring, although the withdrawal rate was high. Telemonitoring is a promising method for supporting both patients and clinicians in the management of CHF. However, further refinements are required to optimize this model of care. CLINICALTRIAL Australian New Zealand Clinical Trial Registry ACTRN12614000916640; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366691

scholarly journals Community Health Workers as a Strategy to Tackle Psychosocial Suffering due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic some family physicians were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psycho-social support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received &lsquo;care as usual&rsquo;. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW in-terventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

Participants’ Understanding of Informed Consent in a Randomized Controlled Trial for Chronic Knee Pain

2015 ◽  
Vol 10 (5) ◽  
pp. 435-443 ◽  
Author(s):  
Marilys Guillemin ◽  
Emma Barnard ◽  
Hannah Walker ◽  
Kim Bennell ◽  
Rana Hinman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Informed Consent ◽  
Knee Pain ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Chronic Knee Pain

Efficacy of a transdiagnostic cognitive-behavioral intervention for eating disorder psychopathology delivered through a smartphone app: a randomized controlled trial

2020 ◽  
pp. 1-12 ◽  
Author(s):  
Jake Linardon ◽  
Adrian Shatte ◽  
John Rosato ◽  
Matthew Fuller-Tyszkiewicz
Keyword(s):  
Randomized Controlled Trial ◽  
Eating Disorder ◽  
Binge Eating ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Smartphone App ◽  
Control Group ◽  
Randomized Controlled ◽  
Post Test ◽  
Secondary Outcomes

Abstract Background Although effective treatments exist for diagnostic and subthreshold-level eating disorders (EDs), a significant proportion of affected individuals do not receive help. Interventions translated for delivery through smartphone apps may be one solution towards reducing this treatment gap. However, evidence for the efficacy of smartphones apps for EDs is lacking. We developed a smartphone app based on the principles and techniques of transdiagnostic cognitive-behavioral therapy for EDs and evaluated it through a pre-registered randomized controlled trial. Methods Symptomatic individuals (those who reported the presence of binge eating) were randomly assigned to the app (n = 197) or waiting list (n = 195). Of the total sample, 42 and 31% exhibited diagnostic-level bulimia nervosa and binge-eating disorder symptoms, respectively. Assessments took place at baseline, 4 weeks, and 8 weeks post-randomization. Analyses were intention-to-treat. The primary outcome was global levels of ED psychopathology. Secondary outcomes were other ED symptoms, impairment, and distress. Results Intervention participants reported greater reductions in global ED psychopathology than the control group at post-test (d = −0.80). Significant effects were also observed for secondary outcomes (d's = −0.30 to −0.74), except compensatory behavior frequency. Symptom levels remained stable at follow-up. Participants were largely satisfied with the app, although the overall post-test attrition rate was 35%. Conclusion Findings highlight the potential for this app to serve as a cost-effective and easily accessible intervention for those who cannot receive standard treatment. The capacity for apps to be flexibly integrated within current models of mental health care delivery may prove vital for addressing the unmet needs of people with EDs.

scholarly journals Weight Lifting and Physical Function Among Survivors of Breast Cancer: A Post Hoc Analysis of a Randomized Controlled Trial

2015 ◽  
Vol 33 (19) ◽  
pp. 2184-2189 ◽  
Author(s):  
Justin C. Brown ◽  
Kathryn H. Schmitz
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Physical Function ◽  
Standard Care ◽  
Controlled Trial ◽  
Weight Lifting ◽  
Control Group ◽  
Post Hoc Analysis ◽  
Randomized Controlled ◽  
Post Hoc

Purpose Survivors of breast cancer may experience deterioration of physical function. This is important because poor physical function may be associated with premature mortality, injurious falls, bone fracture, and disability. We conducted a post hoc analysis to explore the potential efficacy of slowly progressive weight lifting to reduce the incidence of physical function deterioration among survivors of breast cancer. Methods Between October 2005 and August 2008, we conducted a single-blind, 12-month, randomized controlled trial of twice-per-week slowly progressive weight lifting or standard care among 295 survivors of nonmetastatic breast cancer. In this post hoc analysis of data from the Physical Activity and Lymphedema Trial, we examined incident deterioration of physical function after 12 months, defined as a ≥ 10-point decrease in the physical function subscale of the Medical Outcomes Short-Form 36-item questionnaire. Results The proportion of participants who experienced incident physical function deterioration after 12 months was 16.3% (24/147) in the control group and 8.1% (12/148) in the weight lifting group (relative risk, 0.49; 95% CI, 0.25 to 0.96; P = .04). No serious or unexpected adverse events occurred that were related to weight lifting. Conclusion Slowly progressive weight lifting compared with standard care reduced the incidence of physical function deterioration among survivors of breast cancer. These data are hypothesis generating. Future studies should directly compare the efficacy of weight lifting with other modalities of exercise, such as brisk walking, to appropriately inform the development of a confirmatory study designed to preserve physical function among survivors of breast cancer.

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