scholarly journals The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Julia Nordlund ◽  
Richard S. Henry ◽  
Linda Kwakkenbos ◽  
Marie-Eve Carrier ◽  
Brooke Levis ◽  
...  

Abstract Background Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. We completed an initial feasibility trial of an online self-administered version of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program using the cohort multiple randomized controlled trial (RCT) design. Due to low intervention offer uptake, we will conduct a new feasibility trial with progression to full-scale trial, using a two-arm parallel, partially nested RCT design. The SPIN-SELF Program has also been revised to include facilitator-led videoconference group sessions in addition to online material. We will test the group-based intervention delivery format, then evaluate the effect of the SPIN-SELF Program on disease management self-efficacy (primary) and patient activation, social appearance anxiety, and functional health outcomes (secondary). Methods This study is a feasibility trial with progression to full-scale RCT, pending meeting pre-defined criteria, of the SPIN-SELF Program. Participants will be recruited from the ongoing SPIN Cohort (http://www.spinsclero.com/en/cohort) and via social media and partner patient organizations. Eligible participants must have SSc and low to moderate disease management self-efficacy (Self-Efficacy for Managing Chronic Disease (SEMCD) Scale score ≤ 7.0). Participants will be randomized (1:1 allocation) to the group-based SPIN-SELF Program or usual care for 3 months. The primary outcome in the full-scale trial will be disease management self-efficacy based on SEMCD Scale scores at 3 months post-randomization. Secondary outcomes include SEMCD scores 6 months post-randomization plus patient activation, social appearance anxiety, and functional health outcomes at 3 and 6 months post-randomization. We will include 40 participants to assess feasibility. At the end of the feasibility portion, stoppage criteria will be used to determine if the trial procedures or SPIN-SELF Program need important modifications, thereby requiring a re-set for the full-scale trial. Otherwise, the full-scale RCT will proceed, and outcome data from the feasibility portion will be utilized in the full-scale trial. In the full-scale RCT, 524 participants will be recruited. Discussion The SPIN-SELF Program may improve disease management self-efficacy, patient activation, social appearance anxiety, and functional health outcomes in people with SSc. SPIN works with partner patient organizations around the world to disseminate its programs free-of-charge. Trial registration ClinicalTrials.govNCT04246528. Registered on 27 January 2020

10.2196/15927 ◽  
2020 ◽  
Vol 8 (3) ◽  
pp. e15927
Author(s):  
Scott Sittig ◽  
Jing Wang ◽  
Sriram Iyengar ◽  
Sahiti Myneni ◽  
Amy Franklin

Background Although there is a rise in the use of mobile health (mHealth) tools to support chronic disease management, evidence derived from theory-driven design is lacking. Objective The objective of this study was to determine the impact of an mHealth app that incorporated theory-driven trigger messages. These messages took different forms following the Fogg behavior model (FBM) and targeted self-efficacy, knowledge, and self-care. We assess the feasibility of our app in modifying these behaviors in a pilot study involving individuals with diabetes. Methods The pilot randomized unblinded study comprised two cohorts recruited as employees from within a health care system. In total, 20 patients with type 2 diabetes were recruited for the study and a within-subjects design was utilized. Each participant interacted with an app called capABILITY. capABILITY and its affiliated trigger (text) messages integrate components from social cognitive theory (SCT), FBM, and persuasive technology into the interactive health communications framework. In this within-subjects design, participants interacted with the capABILITY app and received (or did not receive) text messages in alternative blocks. The capABILITY app alone was the control condition along with trigger messages including spark and facilitator messages. A repeated-measures analysis of variance (ANOVA) was used to compare adherence with behavioral measures and engagement with the mobile app across conditions. A paired sample t test was utilized on each health outcome to determine changes related to capABILITY intervention, as well as participants’ classified usage of capABILITY. Results Pre- and postintervention results indicated statistical significance on 3 of the 7 health survey measures (general diet: P=.03; exercise: P=.005; and blood glucose: P=.02). When only analyzing the high and midusers (n=14) of capABILITY, we found a statistically significant difference in both self-efficacy (P=.008) and exercise (P=.01). Although the ANOVA did not reveal any statistically significant differences across groups, there is a trend among spark conditions to respond more quickly (ie, shorter log-in lag) following the receipt of the message. Conclusions Our theory-driven mHealth app appears to be a feasible means of improving self-efficacy and health-related behaviors. Although our sample size is too small to draw conclusions about the differential impact of specific forms of trigger messages, our findings suggest that spark triggers may have the ability to cue engagement in mobile tools. This was demonstrated with the increased use of capABILITY at the beginning and conclusion of the study depending on spark timing. Our results suggest that theory-driven personalization of mobile tools is a viable form of intervention. Trial Registration ClinicalTrials.gov NCT04132089; http://clinicaltrials.gov/ct2/show/NCT004122089


2019 ◽  
Author(s):  
Scott Sittig ◽  
Jing Wang ◽  
Sriram Iyengar ◽  
Sahiti Myneni ◽  
Amy Franklin

BACKGROUND Although there is a rise in the use of mobile health (mHealth) tools to support chronic disease management, evidence derived from theory-driven design is lacking. OBJECTIVE The objective of this study was to determine the impact of an mHealth app that incorporated theory-driven trigger messages. These messages took different forms following the Fogg behavior model (FBM) and targeted self-efficacy, knowledge, and self-care. We assess the feasibility of our app in modifying these behaviors in a pilot study involving individuals with diabetes. METHODS The pilot randomized unblinded study comprised two cohorts recruited as employees from within a health care system. In total, 20 patients with type 2 diabetes were recruited for the study and a within-subjects design was utilized. Each participant interacted with an app called capABILITY. capABILITY and its affiliated trigger (text) messages integrate components from social cognitive theory (SCT), FBM, and persuasive technology into the interactive health communications framework. In this within-subjects design, participants interacted with the capABILITY app and received (or did not receive) text messages in alternative blocks. The capABILITY app alone was the control condition along with trigger messages including spark and facilitator messages. A repeated-measures analysis of variance (ANOVA) was used to compare adherence with behavioral measures and engagement with the mobile app across conditions. A paired sample <i>t</i> test was utilized on each health outcome to determine changes related to capABILITY intervention, as well as participants’ classified usage of capABILITY. RESULTS Pre- and postintervention results indicated statistical significance on 3 of the 7 health survey measures (general diet: <i>P</i>=.03; exercise: <i>P</i>=.005; and blood glucose: <i>P</i>=.02). When only analyzing the high and midusers (n=14) of capABILITY, we found a statistically significant difference in both self-efficacy (<i>P</i>=.008) and exercise (<i>P</i>=.01). Although the ANOVA did not reveal any statistically significant differences across groups, there is a trend among spark conditions to respond more quickly (ie, shorter log-in lag) following the receipt of the message. CONCLUSIONS Our theory-driven mHealth app appears to be a feasible means of improving self-efficacy and health-related behaviors. Although our sample size is too small to draw conclusions about the differential impact of specific forms of trigger messages, our findings suggest that spark triggers may have the ability to cue engagement in mobile tools. This was demonstrated with the increased use of capABILITY at the beginning and conclusion of the study depending on spark timing. Our results suggest that theory-driven personalization of mobile tools is a viable form of intervention. CLINICALTRIAL ClinicalTrials.gov NCT04132089; http://clinicaltrials.gov/ct2/show/NCT004122089


10.2196/16799 ◽  
2020 ◽  
Vol 9 (4) ◽  
pp. e16799
Author(s):  
Marie-Eve Carrier ◽  
Linda Kwakkenbos ◽  
Warren R Nielson ◽  
Claire Fedoruk ◽  
Karen Nielsen ◽  
...  

Background Systemic sclerosis (SSc), or scleroderma, is a rare disease that often results in significant disruptions to activities of daily living and can negatively affect physical and psychological well-being. Because there is no known cure, SSc treatment focuses on reducing symptoms and disability and improving health-related quality of life (HRQoL). Self-management programs are known to increase self-efficacy for disease management in many chronic diseases. The Scleroderma Patient-centered Intervention Network (SPIN) developed a Web-based self-management program (SPIN self-management; SPIN-SELF) to increase self-efficacy for disease management and to improve HRQoL for patients with SSc. Objective The proposed study aims to assess the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF program by evaluating the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-SELF program. Methods The SPIN-SELF feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with low disease management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale score ≤7), who have indicated interest in using a Web-based self-management program, will be randomized with a 3:2 ratio into the SPIN-SELF program or usual care for 3 months. Feasibility outcomes include trial implementation processes, required resources and management, scientific aspects, and patient acceptability and usage of the SPIN-SELF program. Results Enrollment of the 40 participants occurred between July 5, 2019, and July 27, 2019. By November 25, 2019, data collection of trial outcomes was completed. Data analysis is underway, and results are expected to be published in 2020. Conclusions The SPIN-SELF program is a self-help tool that may improve disease-management self-efficacy and improve HRQoL in patients with SSc. The SPIN-SELF feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-SELF program. International Registered Report Identifier (IRRID) DERR1-10.2196/16799


2018 ◽  
Author(s):  
Elizabeth Mollard ◽  
Kaleb Michaud

BACKGROUND Patient outcomes are improved and the burden to the health care system is reduced when individuals are active self-managers of their own health. There is a need for technology that facilitates self-management of rheumatoid arthritis (RA) and can reduce the number of patient visits, promptly identify treatment needs, and reduce the costs associated with poor RA management. A mobile app named LiveWith Arthritis (eTreatMD, Vancouver, BC) has been developed that allows patients with RA to use their mobile device to regularly collect self-management data and to take objective measurements of the impact of RA on their finger joints using optical imaging technology. OBJECTIVE The objectives of this pilot study were to (1) gather preliminary data as to whether a mobile app with hand optical imaging capabilities improves self-management behaviors (self-efficacy in managing symptoms and patient activation), (2) determine if app use shows promise in improving health outcomes (Pain, Health Assessment Questionnaire-II [HAQ-II]), and (3) determine barriers to using the mobile app in adults with RA. METHODS This pilot study used a mixed-methods design. The quantitative portion was a traditional 2-group experimental design, and the qualitative portion was a follow-up telephone interview for intervention participants who did not complete the study. Measures of self-management included the Patient-Reported Outcomes Measurement Information System (PROMIS) self-efficacy in managing symptoms (P-SEMS) and Patient Activation Measure (PAM). Health outcomes included pain by Visual Analog Scale and disability by HAQ-II. RESULTS The final sample consisted of 21 intervention participants and 15 controls. There was a statistically significant improvement in P-SEMS and promising trends for improvement in PAM, HAQ-II, and pain scores for participants who used the app. Of the intervention participants who did not complete the study, 12 completed the qualitative interview on barriers to use. Qualitative content analysis revealed 3 themes for barriers to using the app, including (1) frustration with technology, (2) RA made the app difficult to use, and (3) satisfaction with current self-management system. CONCLUSIONS The LiveWith Arthritis app shows promise for improving self-management behaviors and health outcomes in adults with RA. Future study with a larger sample size is required to confirm findings. Initial app experience is important for adoption and continual use of the app. Individuals with significant disability to the hand would benefit from voice-activated app features. Participants who already have a system of managing their RA may not feel compelled to switch methods, even when a novel optical imaging feature is available.


2019 ◽  
Author(s):  
Marie-Eve Carrier ◽  
Linda Kwakkenbos ◽  
Warren R Nielson ◽  
Claire Fedoruk ◽  
Karen Nielsen ◽  
...  

BACKGROUND Systemic sclerosis (SSc), or scleroderma, is a rare disease that often results in significant disruptions to activities of daily living and can negatively affect physical and psychological well-being. Because there is no known cure, SSc treatment focuses on reducing symptoms and disability and improving health-related quality of life (HRQoL). Self-management programs are known to increase self-efficacy for disease management in many chronic diseases. The Scleroderma Patient-centered Intervention Network (SPIN) developed a Web-based self-management program (SPIN self-management; SPIN-SELF) to increase self-efficacy for disease management and to improve HRQoL for patients with SSc. OBJECTIVE The proposed study aims to assess the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF program by evaluating the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-SELF program. METHODS The SPIN-SELF feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with low disease management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale score ≤7), who have indicated interest in using a Web-based self-management program, will be randomized with a 3:2 ratio into the SPIN-SELF program or usual care for 3 months. Feasibility outcomes include trial implementation processes, required resources and management, scientific aspects, and patient acceptability and usage of the SPIN-SELF program. RESULTS Enrollment of the 40 participants occurred between July 5, 2019, and July 27, 2019. By November 25, 2019, data collection of trial outcomes was completed. Data analysis is underway, and results are expected to be published in 2020. CONCLUSIONS The SPIN-SELF program is a self-help tool that may improve disease-management self-efficacy and improve HRQoL in patients with SSc. The SPIN-SELF feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-SELF program. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/16799


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Elizabeth A. Salerno ◽  
Neha P. Gothe ◽  
Jason Fanning ◽  
Lindsay L. Peterson ◽  
Graham A. Colditz ◽  
...  

Abstract Background Supervised physical activity interventions improve functional health during cancer survivorship, but remain costly and inaccessible for many. We previously reported on the benefits of a DVD-delivered physical activity program (FlexToBa™) in older adults. This is a secondary analysis of the intervention effects among cancer survivors in the original sample. Methods Low active, older adults who self-reported a history of cancer (N = 46; M time since diagnosis = 10.7 ± 9.4 years) participated in a 6-month, home-based physical activity intervention. Participants were randomized to either the DVD-delivered physical activity program focused on flexibility, toning, and balance (FlexToBa™; n = 22) or an attentional control condition (n = 24). Physical function was assessed by the Short Physical Performance Battery (SPPB) at baseline, end of intervention, and at 12 and 24 months after baseline. Results Repeated measures linear mixed models indicated a significant group*time interaction for the SPPB total score (β = − 1.14, p = 0.048), driven by improved function from baseline to six months in the FlexToBa™ group. The intervention group also had improved balance (β = − 0.56, p = 0.041) compared with controls. Similar trends emerged for the SPPB total score during follow-up; the group*time interaction from 0 to 12 months approached significance (β = − 0.97, p = 0.089) and was significant from 0 to 24 months (β = − 1.84, p = 0.012). No significant interactions emerged for other outcomes (ps > 0.11). Conclusions A DVD-delivered physical activity intervention designed for cancer-free older adults was capable of eliciting and maintaining clinically meaningful functional improvements in a subgroup of cancer survivors, with similar effects to the original full sample. These findings inform the dissemination of evidence-based physical activity programs during survivorship. Trial registration ClinicalTrials.govNCT01030419. Registered 11 December 2009


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