Dataset Information

Short-Term Findings From Testing EPIO, a Digital Self-Management Program for People Living With Chronic Pain: Randomized Controlled Trial.

ABSTRACT:

Background

Chronic pain conditions involve numerous physical and psychological challenges, and while psychosocial self-management interventions can be of benefit for people living with chronic pain, such in-person treatment is not always accessible. Digital self-management approaches could improve this disparity, potentially bolstering outreach and providing easy, relatively low-cost access to pain self-management interventions.

Objective

This randomized controlled trial aimed to evaluate the short-term efficacy of EPIO (ie, inspired by the Greek goddess for the soothing of pain, Epione), a digital self-management intervention, for people living with chronic pain.

Methods

Patients (N=266) were randomly assigned to either the EPIO intervention (n=132) or a care-as-usual control group (n=134). Outcome measures included pain interference (Brief Pain Inventory; primary outcome measure), anxiety and depression (Hospital Anxiety and Depression Scale), self-regulatory fatigue (Self-Regulatory Fatigue 18 scale), health-related quality of life (SF-36 Short Form Health Survey), pain catastrophizing (Pain Catastrophizing Scale), and pain acceptance (Chronic Pain Acceptance Questionnaire). Linear regression models used change scores as the dependent variables.

Results

The participants were primarily female (210/259, 81.1%), with a median age of 49 (range 22-78) years and a variety of pain conditions. Analyses (n=229) after 3 months revealed no statistically significant changes for the primary outcome of pain interference (P=.84), but significant reductions in the secondary outcomes of depression (mean difference -0.90; P=.03) and self-regulatory fatigue (mean difference -2.76; P=.008) in favor of the intervention group. No other statistically significant changes were observed at 3 months (all P>.05). Participants described EPIO as useful (ie, totally agree or agree; 95/109, 87.2%) and easy to use (101/109, 92.7%), with easily understandable exercises (106/109, 97.2%).

Conclusions

Evidence-informed, user-centered digital pain self-management interventions such as EPIO may have the potential to effectively support self-management and improve psychological functioning in the form of reduced symptoms of depression and improved capacity to regulate thoughts, feelings, and behavior for people living with chronic pain.

Trial registration

ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104.

SUBMITTER: Bostrom K

PROVIDER: S-EPMC10492177 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Publications

Short-Term Findings From Testing EPIO, a Digital Self-Management Program for People Living With Chronic Pain: Randomized Controlled Trial.

Bostrøm Katrine K Børøsund Elin E Eide Hilde H Varsi Cecilie C Kristjansdottir Ólöf Birna ÓB Schreurs Karlein M G KMG Waxenberg Lori B LB Weiss Karen E KE Morrison Eleshia J EJ Stavenes Støle Hanne H Cvancarova Småstuen Milada M Stubhaug Audun A Solberg Nes Lise L

Journal of medical Internet research 20230825

<h4>Background</h4>Chronic pain conditions involve numerous physical and psychological challenges, and while psychosocial self-management interventions can be of benefit for people living with chronic pain, such in-person treatment is not always accessible. Digital self-management approaches could improve this disparity, potentially bolstering outreach and providing easy, relatively low-cost access to pain self-management interventions.<h4>Objective</h4>This randomized controlled trial aimed to ...[more]

PMID: 37624622

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Project description:BackgroundWe present the results of a feasibility, randomized waitlist control group (CG) parallel design study with a 1:1 allocation ratio. Participants were randomized into an intervention group (IG) or a waitlist CG. The intervention was a 6-week digital self-management program, Help to Overcome Problems Effectively (HOPE), for people with cancer.ObjectiveThis study aims to test the feasibility of a digitally delivered self-management program for people with cancer. This will inform the design of a definitive randomized controlled trial. In addition, a preliminary assessment of the impact of the HOPE program via secondary outcomes will be used to assess signals of efficacy in a trial context.MethodsParticipants were drawn from an opportunity sample, referred by Macmillan Cancer Support, and were invited via email to participate in the study (N=61). Primary outcomes were rates of recruitment, retention, follow-up, completion and adherence, sample size and effect size estimation, and assessment of progression criteria for a definitive trial. Secondary outcomes were self-report measures of participants' positive mental well-being, depression, anxiety, and patient activation (ie, confidence in managing their cancer). The intervention and data collection took place on the web.ResultsThe recruitment rate was 77% (47/61). A total of 41 participants completed the baseline questionnaires and were randomized to either the IG (n=21) or the waitlist CG (n=20). The retention rate (attending all program sessions) was greater than 50% (all: 21/41, 51%, IG: 10/21, 48%; and CG: 11/20, 55%). The follow-up rate (completing all questionnaires) was greater than 80% (all: 33/41, 80%; IG: 16/21, 76%; and CG: 17/20, 85%). The completion rate (attending ≥3 sessions and completing all questionnaires) was greater than 60% (all: 25/41, 61%; IG: 13/21, 62%; and CG: 12/20, 60%). Engagement data showed that participants viewed between half (5.1/10, 51%) and three-quarters (12.2/16, 76%) of the pages in each session.ConclusionsAll progression criteria for a definitive trial were met, as supported by the primary outcome data. The IG showed improved postprogram scores on measures of positive mental well-being, depression, anxiety, and patient activation. A full-scale trial of the digital HOPE program for people with cancer will allow us to fully evaluate the efficacy of the intervention relative to a CG.Trial registrationISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250.International registered report identifier (irrid)RR2-10.2196/24264.

Project description:BackgroundChronic pain conditions entail significant personal and societal burdens and improved outreach of evidence-based pain self-management programs are needed. Digital cognitive-behavioral self-management interventions have shown promise. However, evidence is still scarce and several challenges with such interventions for chronic pain exist. Exploring patients' experiences and engagement with digital interventions may be an essential step towards developing meaningful digital self-management interventions for those living with chronic pain.ObjectivesThis study aimed to gain insight into the experiences of people with chronic pain when engaging with EPIO, an application (app)-based cognitive-behavioral pain self-management intervention program.MethodsParticipants (N = 50) living with chronic pain received access to the EPIO intervention in a feasibility pilot-study for 3 months. During this time, all participants received a follow-up phone call at 2-3 weeks, and a subsample (n = 15) also participated in individual semi-structured interviews after 3 months. A qualitative design was used and thematic analysis was employed aiming to capture participants' experiences when engaging with the EPIO intervention program.ResultsFindings identifying program-related experiences and engagement were organized into three main topics, each with three sub-themes: (1) Engaging with EPIO; motivation to learn, fostering joy and enthusiasm, and helpful reminders and personalization, (2) Coping with pain in everyday life; awareness, practice and using EPIO in everyday life, and (3) The value of engaging with the EPIO program; EPIO - a friend, making peace with the presence of pain, and fostering communication and social support.ConclusionsThis qualitative study explored participants' experiences and engagement with EPIO, a digital self-management intervention program for people living with chronic pain. Findings identified valued aspects related to motivation for engagement, and showed how such a program may be incorporated into daily life, and encourage a sense of acceptance, social support and relatedness. The findings highlight vital components for facilitating digital program engagement and use in support of self-management for people living with chronic pain.Trial registrationClinicalTrials.gov NCT03705104 .

Project description:BackgroundChronic pain can be complex and taxing to live with, and treatment and support require a multicomponent approach, which may not always be offered or available. Smartphones, tablets, and personal computers are already incorporated into patients' daily lives, and therefore, they can be used to communicate, educate, and support self-management. Although some web-based self-management interventions exist, research examining the evidence and effect of digital solutions supporting self-management for patients living with chronic pain is limited, findings are inconclusive, and new innovative ideas and solutions are needed.ObjectiveThis feasibility pilot study aimed to explore the system use, perceived usefulness, ease of use, and preliminary effects of EPIO, an app-based cognitive-behavioral pain self-management intervention program for patients living with chronic pain.MethodsThe EPIO intervention was delivered in a blended-care model containing (1) one face-to-face introduction session, (2) nine cognitive behavior-based pain self-management modules, delivered in an app-based format for smartphones or tablets, and (3) one follow-up phone call at 2 to 3 weeks after the introduction session. Patients living with chronic pain (N=50) completed pre-post outcome measures at baseline and 3 months after the introduction session, with registration of system use (ie, log data) until 6 months. The use, perceived usefulness, and ease of use of the EPIO program were examined through system use data, as well as a study-specific use/usability questionnaire and the System Usability Scale (SUS). Outcome measures to test feasibility of use and estimate preliminary effects included the Brief Pain Inventory, health-related quality of life (HRQoL) scale, Hospital Anxiety and Depression Scale, Self-Regulatory Fatigue scale, Pain Catastrophizing Scale, and Chronic Pain Acceptance Questionnaire.ResultsParticipants (N=50) had a median age of 52 years (range 29-74 years) at inclusion and were mainly female (40/50, 80%). Thirty-one participants completed at least six of the nine modules within the 3-month study period (62% completion rate). Forty-five participants completed outcome measures at 3 months, and the EPIO program was rated as useful (ie, "totally agree" or "agree"; 39/45, 87%) and easy to use (42/45, 93%), and as having easily understandable exercises (44/45, 98%). The average overall system usability (SUS) score was 85.7, indicating grade A and excellent system usability. Preliminary psychosocial outcome measure estimates showed primarily nonsignificant pre-post intervention improvements at 3 months, but with significant positive effects related to some aspects of HRQoL (bodily pain, P=.02 and change, P=.049).Conclusions Digital self-management intervention programs may be of use and support for patients living with chronic pain. In this feasibility study, EPIO showed an acceptable program completion rate and was rated as useful and easy to use, with excellent user satisfaction. Program optimization and efficacy testing in a large-scale randomized controlled trial are warranted and in progress.Trial registrationClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104.

Project description:BackgroundHealth care self-management is important for people living with nondialysis chronic kidney disease (CKD). However, the few available resources are of variable quality.ObjectiveThis work describes the systematic codevelopment of "My Kidneys & Me" (MK&M), a theory-driven and evidence-based digital self-management resource for people with nondialysis CKD, guided by an established process used for the successful development of the diabetes education program MyDESMOND (Diabetes Education and Self-Management for Ongoing and Newly Diagnosed, DESMOND).MethodsA multidisciplinary steering group comprising kidney health care professionals and researchers and specialists in the development of complex interventions and digital health provided expertise in the clinical and psychosocial aspects of CKD, self-management, digital health, and behavior change. A patient and public involvement group helped identify the needs and priorities of MK&M and co-design the resource. MK&M was developed in 2 sequential phases. Phase 1 involved the codevelopment process of the MK&M resource (content and materials), using Intervention Mapping (IM) as a framework. The first 4 IM steps guided the development process: needs assessment was conducted to describe the context of the intervention; intervention outcomes, performance objectives, and behavioral determinants were identified; theory- and evidence-based change methods and practical strategies to deliver change methods were selected; and program components were developed and refined. Phase 2 involved the adoption and adaptation of the existing MyDESMOND digital platform to suit the MK&M resource.ResultsThe needs assessment identified that individuals with CKD have multiple differing needs and that delivering a self-management program digitally would enable accessible, tailored, and interactive information and support. The intended outcomes of MK&M were to improve and maintain effective self-management behaviors, including physical activity and lifestyle, improve knowledge, promote self-care skills, increase self-efficacy, and enhance well-being. This was achieved through the provision of content and materials designed to increase CKD knowledge and patient activation, reduce health risks, manage symptoms, and improve physical function. Theories and behavior change techniques selected include Self-Management Framework, Capability, Opportunity, Motivation Behavior model components of Behaviour Change Wheel and taxonomy of behavior change techniques, Health Action Process Approach Model, Common Sense Model, and Social Cognitive Theory. The program components developed comprised educational and behavior change sessions, health trackers (eg, monitoring blood pressure, symptoms, and exercise), goal-setting features, and forums for social support. The MyDESMOND digital platform represented an ideal existing platform to host MK&M; thus, the MyDESMOND interface and features were adopted and adapted for MK&M.ConclusionsApplying the IM framework enabled the systematic application of theory, empirical evidence, and practical perspectives in the codevelopment of MK&M content and materials. Adopting and adapting a preexisting platform provided a cost- and time-efficient approach for developing our digital intervention. In the next stage of work, the efficacy of MK&M in increasing patient activation will be tested in a randomized controlled trial.

Project description:BackgroundLow back pain (LBP) is prevalent across all social classes, in all age groups, and across industrialized and developing countries. From a global perspective, LBP is considered the leading cause of disability and negatively impacts everyday life and well-being. Self-management is a recommended first-line treatment, and mobile apps are a promising platform to support self-management of conditions like LBP. In the selfBACK project, we have developed a digital decision support system made available for the user via an app intended to support tailored self-management of nonspecific LBP.ObjectiveThe trial aims to evaluate the effectiveness of using the selfBACK app to support self-management in addition to usual care (intervention group) versus usual care only (control group) in people with nonspecific LBP.MethodsThis is a single-blinded, randomized controlled trial (RCT) with two parallel arms. The selfBACK app provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of plans is achieved by using case-based reasoning (CBR) methodology, which is a branch of artificial intelligence. The core of the CBR methodology is to use data about the current case (participant) along with knowledge about previous and similar cases to tailor the self-management plan to the current case. This enables a person-centered intervention based on what has and has not been successful in previous cases. Participants in the RCT are people with LBP who consulted a health care professional in primary care within the preceding 8 weeks. Participants are randomized to using the selfBACK app in addition to usual care versus usual care only. We aim to include a total of 350 participants (175 participants in each arm). Outcomes are collected at baseline, 6 weeks, and 3, 6, and 9 months. The primary end point is difference in pain-related disability between the intervention group and the control group assessed by the Roland-Morris Disability Questionnaire at 3 months.ResultsThe trial opened for recruitment in February 2019. Data collection is expected to be complete by fall 2020, and the results for the primary outcome are expected to be published in fall 2020.ConclusionsThis RCT will provide insights regarding the benefits of supporting tailored self-management of LBP through an app available at times convenient for the user. If successful, the intervention has the potential to become a model for the provision of tailored self-management support to people with nonspecific LBP and inform future interventions for other painful musculoskeletal conditions.Trial registrationClinicalTrial.gov NCT03798288; https://clinicaltrials.gov/ct2/show/NCT03798288.International registered report identifier (irrid)DERR1-10.2196/14720.

Project description:Chronic pain affects up to 28% of U.S. adults, costing ∼$560 billion each year. Chronic pain is an instantiation of the perennial complexity of how to best assess and treat chronic diseases over time, especially in populations where age, medical comorbidities, and socioeconomic barriers may limit access to care. Chronic disease management poses a particular challenge for the healthcare system's transition from fee-for-service to value and risk-based reimbursement models. Remote, passive real-time data from smartphones could enable more timely interventions and simultaneously manage risk and promote better patient outcomes through predicting and preventing costly adverse outcomes; however, there is limited evidence whether remote monitoring is feasible, especially in the case of older patients with chronic pain. Here, we introduce the Pain Intervention and Digital Research (Pain-IDR) Program as a pilot initiative launched in 2022 that combines outpatient clinical care and digital health research. The Pain-IDR seeks to test whether functional status can be assessed passively, through a smartphone application, in older patients with chronic pain. We discuss two perspectives-a narrative approach that describes the clinical settings and rationale behind changes to the operational design, and a quantitative approach that measures patient recruitment, patient experience, and HERMES data characteristics. Since launch, we have had 77 participants with a mean age of 55.52, of which n = 38 have fully completed the 6 months of data collection necessitated to be considered in the study, with an active data collection rate of 51% and passive data rate of 78%. We further present preliminary operational strategies that we have adopted as we have learned to adapt the Pain-IDR to a productive clinical service. Overall, the Pain-IDR has successfully engaged older patients with chronic pain and presents useful insights for others seeking to implement digital phenotyping in other chronic disease settings.

Project description:BackgroundOsteoarthritis (OA) is not curable, but the symptoms can be managed through self-management programs (SMPs). Owing to the growing burden of OA on the health system and the need to ensure high-quality integrated services, delivering SMPs through digital technologies could be an economic and effective community-based approach.ObjectiveThis study aims to analyze the effectiveness of digital-based structured SMPs on patient outcomes in people with OA.MethodsA total of 7 web-based and 3 gray literature databases were searched for randomized controlled trials assessing digital-based structured SMPs on self-reported outcomes including pain, physical function, disability, and health-related quality of life (QoL) in people with OA. Two reviewers independently screened the search results and reference lists of the identified papers and related reviews. Data on the intervention components and delivery and behavioral change techniques used were extracted. A meta-analysis, risk of bias sensitivity analysis, and subgroup analysis were performed where appropriate. The Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach was used to assess the quality of evidence.ResultsA total of 8 studies were included in this review involving 2687 patients with knee (n=2); knee, hip, or both (n=5); and unspecified joint (n=1) OA. SMPs were delivered via telephone plus audio and video, internet, or mobile apps. Studies reported that digital-based structured SMPs compared with the treatment as usual control group (n=7) resulted in a significant, homogeneous, medium reduction in pain and improvement in physical function (standardized mean difference [SMD] -0.28, 95% CI -0.38 to -0.18 and SMD -0.26, 95% CI -0.35 to -0.16, respectively) at posttreatment. The digital-based structured SMP effect on pain and function reduced slightly at the 12-month follow-up but remained to be medium and significant. The posttreatment effect of digital-based structured SMPs was small and significant for disability, but nonsignificant for QoL (SMD -0.10, 95% CI -0.17 to 0.03 and SMD -0.17, 95% CI -0.47 to 0.14, respectively; each reported in 1 study only). The 12-month follow-up effect of the intervention was very small for disability and QoL. The quality of evidence was rated as moderate for pain and physical function and low and very low for disability and QoL, respectively, using the GRADE approach.ConclusionsDigital-based structured SMPs may result in improvement in pain and physical function that is largely sustained at the 12-month follow-up in people with knee and hip OA. The effects on disability and QoL are smaller and less clear. The quality of evidence is moderate to low, and further research is required to confirm the findings of the review and assess the effects of digital-based structured SMPs on other health-related outcomes.

Dataset Information

Short-Term Findings From Testing EPIO, a Digital Self-Management Program for People Living With Chronic Pain: Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

Publications

Short-Term Findings From Testing EPIO, a Digital Self-Management Program for People Living With Chronic Pain: Randomized Controlled Trial.

Similar Datasets

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