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Improving chronic pain management with eHealth and mHealth: study protocol for a randomised controlled trial.

ABSTRACT: INTRODUCTION:Chronic pain has become a matter of public health concern due to its high prevalence and because public costs associated with treatment and disability increase each year. Research suggests that limitations in the traditional assessment of chronic pain patients limit the effectiveness of current medical treatments. The use of technology might serve change patient traditional monitoring into ecological momentary assessments, which might be visualised by physicians live. This study describes a randomised control trial designed to test the utility of a technology-based solution for pain telemonitoring consisting of a smartphone app for patients and a web application for physicians. The goal of this study will be to explore whether this combination of eHealth and mHealth improves the effectiveness of existing pain treatments. METHODS AND ANALYSIS:Participants will be 250 patients randomly assigned to one of these two conditions: treatment-as-usual (TAU) and TAU +app+?web. All participants will receive the usual treatment for their pain. Only the TAU +app+?web group use Pain Monitor app, which generates alarms that are sent to the physicians in the face of previously established undesired events. Physicians will be able to monitor app reports using a web application, which might result in an adjustment of treatment. We anticipate that the use of Pain Monitor plus the therapist web will result in a reduction of pain intensity and side effects of the medication. Improvements on secondary outcomes, namely fatigue, mood, pain interference, rescue medication use and quality of life, are also expected. Mixed repeated-measure multivariate analyses of variances will be conducted to investigate whether there are differences between preassessment and postassessment scores as a function of the experimental condition. ETHICS AND DISSEMINATION:Ethical approval from the Hospital General Universitari de Castellon was obtained. The findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT03606265.

SUBMITTER: Jaen I

PROVIDER: S-EPMC6937108 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Improving chronic pain management with eHealth and mHealth: study protocol for a randomised controlled trial.

Jaén Irene I Suso-Ribera Carlos C Castilla Diana D Zaragoza Irene I García-Palacios Azucena A Gómez Palones Jose Luis JL

BMJ open 20191229 12

<h4>Introduction</h4>Chronic pain has become a matter of public health concern due to its high prevalence and because public costs associated with treatment and disability increase each year. Research suggests that limitations in the traditional assessment of chronic pain patients limit the effectiveness of current medical treatments. The use of technology might serve change patient traditional monitoring into ecological momentary assessments, which might be visualised by physicians live. This s ...[more]

PMID: 31888939

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Project description:INTRODUCTION:For patients with advanced cancer, research shows that pain is frequent, burdensome and undertreated. Evidence-based approaches to support cancer pain management have been developed but have not been implemented within the context of the UK National Health Service. This protocol is for a pragmatic multicentre randomised controlled trial (RCT) to assess feasibility, acceptability, effectiveness and cost-effectiveness for a multicomponent intervention for pain management in patients with advanced cancer. METHODS AND ANALYSIS:This trial will assess the feasibility of implementation and uptake of evidence-based interventions, developed and piloted as part of the Improving the Management of Pain from Advanced Cancer in the Community Programme grant, into routine clinical practice and determine whether there are potential differences with respect to patient-rated pain, patient pain knowledge and experience, healthcare use, quality of life and cost-effectiveness. 160 patients will receive either the intervention (usual care plus supported self-management) delivered within the oncology clinic and palliative care services by locally assigned community palliative care nurses, consisting of a self-management educational intervention and eHealth intervention for routine pain assessment and monitoring; or usual care. The primary outcomes are to assess implementation and uptake of the interventions, and differences in terms of pain severity. Secondary outcomes include pain interference, participant pain knowledge and experience, and cost-effectiveness. Outcome assessment will be blinded and patient-reported outcome measures collected via post at 6 and 12 weeks following randomisation. ETHICS AND DISSEMINATION:This RCT has the potential to significantly influence National Health Service delivery to community-based patients with pain from advanced cancer. We aim to provide definitive evidence of whether two simple interventions delivered by community palliative care nurse in palliative care that support-self-management are clinically effective and cost-effective additions to standard community palliative care. TRIAL REGISTRATION NUMBER:ISRCTN18281271; Pre-results.

Project description:BackgroundChronic pain (CP) has serious medical and social consequences and leads to economic burden that threatens the sustainability of healthcare services. Thus, optimized management of pain tools to support CP patients in adjusting to their condition and improving their quality of life is timely. Although acceptance and commitment therapy (ACT) is considered an evidence-based psychological approach for CP, evidence for the efficacy of online-delivered ACT for CP is still scarce. At the same time, studies suggest that self-compassion mediates the change in disability and psychopathological symptoms in ACT interventions for CP, although self-compassion is not a specific target in ACT. Thus, an explicit focus on self-compassion might increase the efficacy of ACT interventions for CP, although this hypothesis has not been tested. This study aims to develop an eHealth ACT and compassion-based self-management intervention for CP, the iACTwithPain, and to compare its efficacy in improving health outcomes to a similar ACT-only intervention and a medical TAU group.MethodsThe eHealth platform that will host the interventions will be developed using a flat design identity and will be interactive. The iACTwithPain intervention will comprise eight weekly self-management sessions and will be developed taking into consideration the psychological flexibility model applied to CP, with the addition of explicit compassion-based components. To analyze whether the iACTwithPain intervention will present superiority in improving CP's impact and related health markers over the two other conditions, this study will follow an RCT design with three arms. CP patients will be recruited through direct contact with patient associations and healthcare services and a national press release in Portugal. Outcome measurement will be conducted at baseline, post-intervention and at 3- and 6-month follow-ups. The interventions' acceptability will also be assessed.DiscussionThe iACTwithPain intervention is expected to improve CP patients' psychosocial functioning, quality of life, and empowerment, by promoting adaptive disease management and regulation of pain-related internal experiences. Results will contribute to a better understanding on the pertinence of adding compassion elements to ACT for CP and to reach an optimized intervention for CP.Clinical trial registrationThis trial has been registered at ClinicalTrials.Gov (NCT04200183; 16 December 2019; https://clinicaltrials.gov/ct2/show/NCT04200183). The current manuscript comprises the first version of this clinical trial's protocol.

Project description:An increasing number of people are living with multimorbidity. The evidence base for how best to manage these patients is weak. Current clinical guidelines generally focus on single conditions, which may not reflect the needs of patients with multimorbidity. The aim of the 3D study is to develop, implement and evaluate an intervention to improve the management of patients with multimorbidity in general practice.This is a pragmatic two-arm cluster randomised controlled trial. 32 general practices around Bristol, Greater Manchester and Glasgow will be randomised to receive either the '3D intervention' or usual care. 3D is a complex intervention including components affecting practice organisation, the conduct of patient reviews, integration with secondary care and measures to promote change in practice organisation. Changes include improving continuity of care and replacing reviews of each disease with patient-centred reviews with a focus on patients' quality of life, mental health and polypharmacy. We aim to recruit 1383 patients who have 3 or more chronic conditions. This provides 90% power at 5% significance level to detect an effect size of 0.27 SDs in the primary outcome, which is health-related quality of life at 15 months using the EQ-5D-5L. Secondary outcome measures assess patient centredness, illness burden and treatment burden. The primary analysis will be a multilevel regression model adjusted for baseline, stratification/minimisation, clustering and important co-variables. Nested process evaluation will assess implementation, mechanisms of effectiveness and interaction of the intervention with local context. Economic analysis of cost-consequences and cost-effectiveness will be based on quality-adjusted life years.This study has approval from South-West (Frenchay) National Health Service (NHS) Research Ethics Committee (14/SW/0011). Findings will be disseminated via final report, peer-reviewed publications and guidance to healthcare professionals, commissioners and policymakers.ISRCTN06180958; Pre-results.

Project description:INTRODUCTION:Multimorbidity increases care needs and primary care use among people with chronic diseases. The Concerto Health Program (CHP) has been developed to optimise chronic disease management in primary care services. However, in its current version, the CHP primarily targets clinicians and does not aim to answer directly patients' and their informal caregivers' needs for chronic disease management. Various studies have shown that interventions that increase patient activation level are associated with better health outcomes. Furthermore, educational tools must be adapted to patients and caregivers in terms of health literacy and usability. This project aims to develop, implement and evaluate a user-centred, multifunctional and personalised eHealth platform (CONCERTO+) to promote a more active patient role in chronic disease management and decision-making. METHODS AND ANALYSIS:This project uses a collaborative research approach, aiming at the personalisation of CHP through three phases: (1) the development of one module of an eHealth platform based on scientific evidence and user-centred design; (2) a feasibility study of CONCERTO+ through a pilot cluster randomised controlled trial where patients with chronic diseases from a primary healthcare practice will receive CONCERTO+ during 6 months and be compared to patients from a control practice receiving usual care and (3) an analysis of CONCERTO+ potential for scaling up. To do so, we will conduct two focus groups with patients and informal caregivers and individual interviews with health professionals at the two study sites, as well as health care managers, information officers and representatives of the Ministry of Health. ETHICS AND DISSEMINATION:This study received ethical approval from Ethics Committee of Université Laval. The findings will be used to inform the effectiveness of CONCERTO+ to improve management care in chronic diseases. We will disseminate findings through presentations in scientific conferences and publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT03628963; Pre-results.

Project description:INTRODUCTION:Chronic musculoskeletal pain is a complex medical condition that can significantly impact quality of life. Patients with chronic pain demonstrate attentional biases towards pain-related information. The therapeutic benefits of modifying attentional biases by implicitly training attention away from pain-related information towards neutral information have been supported in a small number of published studies. Limited research however has explored the efficacy of modifying pain-related biases via the internet. This protocol describes a randomised, double-blind, internet-delivered attentional bias modification intervention, aimed to evaluate the efficacy of the intervention on reducing pain interference. Secondary outcomes are pain intensity, state and trait anxiety, depression, pain-related fear, and sleep impairment. This study will also explore the effects of training intensity on these outcomes, along with participants' perceptions about the therapy. METHODS AND ANALYSIS:The study is a double-blind, randomised controlled trial with four arms exploring the efficacy of online attentional bias modification training versus placebo training theorised to offer no specific therapeutic benefit. Participants with chronic musculoskeletal pain will be randomised to one of four groups: (1) 10-session attentional modification group; (2) 10-session placebo training group; (3) 18-session attentional modification group; or (4) 18-session placebo training group. In the attentional modification groups, the probe-classification version of the visual-probe task will be used to implicitly train attention away from threatening information towards neutral information. Following the intervention, participants will complete a short interview exploring their perceptions about the online training. In addition, a subgroup analysis for participants aged 16-24 and 25-60 will be undertaken. ETHICS AND DISSEMINATION:This study has been approved by the University of Southampton Research Ethics Committee. Results will be published in peer-reviewed journals, academic conferences, and in lay reports for pain charities and patient support groups. TRIAL REGISTRATION NUMBER:NCT02232100; Pre-results.

Project description:BACKGROUND: Acupuncture is increasingly being used for many conditions including chronic neck pain. However the evidence remains inconclusive, indicating the need for further well-designed research. The aim of this study was to conduct a pilot randomised controlled parallel arm trial, to establish key features required for the design and implementation of a large-scale trial on acupuncture for chronic neck pain. METHODS: Patients whose GPs had diagnosed neck pain were recruited from one general practice, and randomised to receive usual GP care only, or acupuncture (up to 10 treatments over 3 months) as an adjunctive treatment to usual GP care. The primary outcome measure was the Northwick Park Neck Pain Questionnaire (NPQ) at 3 months. The primary analysis was to determine the sample size for the full scale study. RESULTS: Of the 227 patients with neck pain identified from the GP database, 28 (12.3%) consenting patients were eligible to participate in the pilot and 24 (10.5%) were recruited to the trial. Ten patients were randomised to acupuncture, receiving an average of eight treatments from one of four acupuncturists, and 14 were randomised to usual GP care alone. The sample size for the full scale trial was calculated from a clinically meaningful difference of 5% on the NPQ and, from this pilot, an adjusted standard deviation of 15.3%. Assuming 90% power at the 5% significance level, a sample size of 229 would be required in each arm in a large-scale trial when allowing for a loss to follow-up rate of 14%. In order to achieve this sample, one would need to identify patients from databases of GP practices with a total population of 230,000 patients, or approximately 15 GP practices roughly equal in size to the one involved in this study (i.e. 15,694 patients). CONCLUSION: This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence base on acupuncture for neck pain.

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Improving chronic pain management with eHealth and mHealth: study protocol for a randomised controlled trial.

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Improving chronic pain management with eHealth and mHealth: study protocol for a randomised controlled trial.

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