Dataset Information

Digital Self-Management in Support of Patients Living With Chronic Pain: Feasibility Pilot Study.

ABSTRACT: BACKGROUND:Chronic 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. OBJECTIVE:This 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. METHODS:The 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. RESULTS:Participants (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 REGISTRATION:ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104.

SUBMITTER: Bostrom K

PROVIDER: S-EPMC7647816 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Digital Self-Management in Support of Patients Living With Chronic Pain: Feasibility Pilot Study.

Bostrøm Katrine K Børøsund Elin E Varsi Cecilie C Eide Hilde H Flakk Nordang Elise E Schreurs Karlein Mg KM Waxenberg Lori B LB Weiss Karen E KE Morrison Eleshia J EJ Cvancarova Småstuen Milada M Stubhaug Audun A Solberg Nes Lise L

JMIR formative research 20201023 10

<h4>Background</h4>Chronic 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 s ...[more]

PMID: 33094734

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Project description:BackgroundChronic low back pain can lead to individual suffering, high medical expenditures, and impaired social well-being. Although the role of physical activity in pain management is well established, the underlying mechanisms of biological and clinical outcomes are unknown. This study aimed to assess the feasibility and acceptability of a pain self-management intervention, Problem-Solving Pain to Enhance Living Well, which employs wearable activity tracking technology and nurse consultations for people with chronic low back pain.MethodsThis one-arm longitudinal study recruited 40 adults aged 18-60 years with chronic low back pain. Over 12 weeks, participants watched 10 short video modules, wore activity trackers, and participated in nurse consultations every 2 weeks. At baseline and the 12-week follow-up, they completed study questionnaires, quantitative sensory testing, and blood sample collection.ResultsForty participants were recruited, and their mean age was 29.8. Thirty-two participants completed the survey questionnaire, quantitative sensory testing, Fitbit activity tracker, and bi-weekly nurse consultation, and 25 completed the evaluation of biological markers. The overall satisfaction with the Problem-Solving Pain to Enhance Living Well video modules, nurse consultations, and Fitbit in pain management was rated as excellent. No adverse events were reported. Between the baseline and 12-week follow-up, there was a significant decrease in pain intensity and interference and an increase in the warm detection threshold at the pain site.ConclusionsDespite concerns about the participant burden due to multidimensional assessment and intensive education, the feasibility of the Problem-Solving Pain to Enhance Living Well intervention was favorable. Technology-based self-management interventions can offer personalized strategies by integrating pain phenotypes, genetic markers, and physical activity types affecting pain conditions.Trial registrationThis pilot study was registered with ClinicalTrials.gov [NCT03637998, August 20, 2018]. The first participant was enrolled on September 21, 2018.

Project description:BackgroundChronic 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.ObjectiveThis 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.MethodsPatients (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.ResultsThe 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%).ConclusionsEvidence-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 registrationClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104.

Project description:BackgroundLow back pain (LBP) is a common cause of disability and is ranked as the most burdensome health condition globally. Self-management, including components on increased knowledge, monitoring of symptoms, and physical activity, are consistently recommended in clinical guidelines as cost-effective strategies for LBP management and there is increasing interest in the potential role of digital health.ObjectiveThe study aimed to synthesize and critically appraise published evidence concerning the use of interactive digital interventions to support self-management of LBP. The following specific questions were examined: (1) What are the key components of digital self-management interventions for LBP, including theoretical underpinnings? (2) What outcome measures have been used in randomized trials of digital self-management interventions in LBP and what effect, if any, did the intervention have on these? and (3) What specific characteristics or components, if any, of interventions appear to be associated with beneficial outcomes?MethodsBibliographic databases searched from 2000 to March 2016 included Medline, Embase, CINAHL, PsycINFO, Cochrane Library, DoPHER and TRoPHI, Social Science Citation Index, and Science Citation Index. Reference and citation searching was also undertaken. Search strategy combined the following concepts: (1) back pain, (2) digital intervention, and (3) self-management. Only randomized controlled trial (RCT) protocols or completed RCTs involving adults with LBP published in peer-reviewed journals were included. Two reviewers independently screened titles and abstracts, full-text articles, extracted data, and assessed risk of bias using Cochrane risk of bias tool. An independent third reviewer adjudicated on disagreements. Data were synthesized narratively.ResultsOf the total 7014 references identified, 11 were included, describing 9 studies: 6 completed RCTs and 3 protocols for future RCTs. The completed RCTs included a total of 2706 participants (range of 114-1343 participants per study) and varied considerably in the nature and delivery of the interventions, the duration/definition of LBP, the outcomes measured, and the effectiveness of the interventions. Participants were generally white, middle aged, and in 5 of 6 RCT reports, the majority were female and most reported educational level as time at college or higher. Only one study reported between-group differences in favor of the digital intervention. There was considerable variation in the extent of reporting the characteristics, components, and theories underpinning each intervention. None of the studies showed evidence of harm.ConclusionsThe literature is extremely heterogeneous, making it difficult to understand what might work best, for whom, and in what circumstances. Participants were predominantly female, white, well educated, and middle aged, and thus the wider applicability of digital self-management interventions remains uncertain. No information on cost-effectiveness was reported. The evidence base for interactive digital interventions to support patient self-management of LBP remains weak.

Project description:BackgroundFamily-based behavioral therapy is an efficacious approach to deliver weight management counseling to children and their parents. However, most families do not have access to in-person, evidence-based treatment. We previously developed and tested DRIVE (Developing Relationships that Include Values of Eating and Exercise), a home-based parent training program to maintain body weight among children at risk for obesity, with the intent to eventually disseminate it nationally alongside SafeCare, a parent support program that focuses on parent-child interactions. Currently the DRIVE program has only been tested independently of SafeCare. This study created the "mHealth DRIVE" program by further adapting DRIVE to incorporate digital and mobile health tools, including remotely delivered sessions, a wireless scale that enabled a child-tailored weight graph, and a pedometer. Telehealth delivery via mHealth platforms and other digital tools can improve program cost-effectiveness, deliver long-term care, and directly support both families and care providers.ObjectiveThe objective of this study was to examine preliminary acceptability and effectiveness of the mHealth DRIVE program among children and parents who received it and among SafeCare providers who potentially could deliver it.MethodsStudy 1 was a 13-week pilot study of a remotely delivered mHealth family-based weight management program. Satisfaction surveys were administered, and height and weight were measured pre- and post-study. Study 2 was a feasibility/acceptability survey administered to SafeCare providers.ResultsParental and child satisfaction (mean of 4.9/6.0 and 3.8/5.0, respectively) were high, and children's (N=10) BMI z-scores significantly decreased (mean -0.14, SD 0.17; P=.025). Over 90% of SafeCare providers (N=74) indicated that SafeCare families would benefit from learning how to eat healthily and be more active, and 80% of providers reported that they and the families would benefit from digital tools to support child weight management.ConclusionsPediatric mHealth weight management interventions show promise for effectiveness and acceptability by families and providers.Trial registrationClinicaltrials.gov NCT03297541, https://clinicaltrials.gov/ct2/show/NCT03297541.

Project description:Background:Very few of the publicly available apps directed towards self-management of low back pain (LBP) have been rigorously tested and their theoretical underpinnings seldom described. The selfBACK app was developed in collaboration with end-users and clinicians and its content is supported by best evidence on self-management of LBP. The objectives of this pilot study were to investigate the basis for recruitment and screening procedures for the subsequent randomized controlled trial (RCT), to test the inclusion process in relation to questionnaires and app installation, and finally to investigate the change in primary outcome over time. Methods:This single-armed pilot study enrolled 51 participants who had sought help for LBP of any duration from primary care (physiotherapy, chiropractic, or general practice) within the past 8?weeks. Participants were screened for eligibility using the PROMIS-Physical-Function-4a questionnaire. Participants were asked to use the selfBACK app for 6?weeks. The app provided weekly tailored self-management plans targeting physical activity, strength and flexibility exercises, and education. The construction of the self-management plans was achieved using case-based reasoning (CBR) methodology to capture and reuse information from previous successful cases. Participants completed the primary outcome pain-related disability (Roland-Morris Disability Questionnaire [RMDQ]) at baseline and 6-week follow-up along with a range of secondary outcomes. Metrics of app use were collected throughout the intervention period. Results:Follow-up data at 6?weeks was obtained for 43 participants. The recruitment procedures were feasible, and the number needed to screen was acceptable (i.e., 1.6:1). The screening questionnaire was altered during the pilot study. The inclusion process, answering questionnaires and app installation, were feasible. The primary outcome (RMDQ) improved from 8.6 (SD 5.1) at baseline to 5.9 (SD 4.0) at 6-week follow-up (change score 1.8, 95% CI 0.7 to 2.9). Participants spent on average 134?min (range 0-889?min) using the app during the 6-week period. Conclusion:The recruitment, screening, and inclusion procedures were feasible for the subsequent RCT with a small adjustment. The improvement on the RMDQ from baseline to follow-up was small. Time pattern of app usage varied considerably between the participants. Trial registration:NCT03697759. Registered on August 10, 2018. https://clinicaltrials.gov/ct2/show/NCT03697759.

Project description:Patients with chronic low back (cLBP) pain report reduced physical function and ability to participate in social roles and are more likely to use opioid pain medications. While self-management interventions have been shown to support these patients, their effectiveness has been limited due to poor patient engagement. "Patient activation" encompasses the skills, knowledge, and motivation that a person has to manage their health. Supporting patient activation may improve the effectiveness of self-management for cLBP. In this single-masked pilot study of adults with cLBP, patients were randomized to receive either no intervention (control) or 6 weekly sessions of an evidence-based web-based self-management program (SMP) with or without health behavior change counseling (HBCC) using motivational interviewing. Participants were assessed at baseline and at 12 and 26 weeks using the Patient Activation Measure, Oswestry Disability Index and PROMIS physical function, social role participation, and pain interference. We assessed acceptability and feasibility based on recruitment, session attendance, and follow-up. Of 187 individuals screened, 105 were eligible and 34 were randomized to control (n = 12), SMP (n = 4), or SMP + HBCC (n = 18). The population had 19 women, 22 patients married or living with significant other, 13 Black or African American patients, and 4 Hispanic or Latino patients. Participants had a mean (SD) Oswestry Disability Index score of 42 (12), moderate impairments in physical function (40 (6.6)) and social roles (45 (10)), and moderately severe pain interference (61 (6.7)). Of 22 participants receiving SMP sessions, 20 participated in at least 1, 15 participated in at least 3, and 7 participated in all 6 sessions. Loss to follow-up was 6 over the 26-week study. Participants in the SMP and SMP + HBCC groups had at least medium effect size improvements in Patient Activation Measures and small-to-medium effect size improvements in Oswestry Disability Index scores and physical function and large effect size improvement in social roles at 12 weeks. Improvements persisted in the SMP + HBCC group at 26 weeks. A web-based SMP is acceptable and feasible in this population. Participants who received augmentation with HBCC had persistent improvements in health outcomes at 26 weeks. ClinicalTrials.gov Identifier NCT06236529 (2/1/2024 - retrospectively registered).

Dataset Information

Digital Self-Management in Support of Patients Living With Chronic Pain: Feasibility Pilot Study.

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Digital Self-Management in Support of Patients Living With Chronic Pain: Feasibility Pilot Study.

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