scholarly journals Online mindfulness-based intervention to prevent chronic pain after cardiac surgery: Protocol of a pilot randomized controlled trial (Preprint)

2021 ◽  
Author(s):  
Geraldine Martorella ◽  
Adam W. Hanley ◽  
Scott M. Pickett ◽  
Céline Gelinas
Keyword(s):  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Cardiac Surgery ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Management ◽  
Opioid Use ◽  
Pain Acceptance ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

BACKGROUND Cardiac surgeries are frequent procedures. However, pain after cardiac surgery may become chronic (lasting >3 months) in adults. Once discharged from the hospital, patients are at greater risk for chronic post-surgical pain (CPSP) and prolonged opioid use, as they need to self-manage their pain. Psychological risk and protective factors, such as pain-related catastrophic thoughts and pain acceptance, will determine their ability to cope and their opioid use, which makes a support for pain self-management crucial. Studies on mindfulness-based cognitive therapy (MBCT) have multiplied regarding their potential effect on pain acceptance and catastrophic thoughts. Brief, Online MBCT for the prevention of CPSP have not been examined. OBJECTIVE We will pilot test a brief online 4-week MBCT intervention for adults following discharge from hospital by 1) assessing the acceptability/feasibility of the intervention; and 2) examining preliminary effects on pain intensity, pain interference with activities and opioid use, as well as pain acceptance and catastrophic thoughts in the 6 months following surgery. METHODS A double blinded pilot randomized controlled trial will be used to assess the online MBCT intervention. Patients will be selected according to the following criteria: a) age ≥ 18 years, b) first-time elective cardiac surgery via a median sternotomy, c) worst pain in the past week ≥4/10, d) ability to understand and complete questionnaires in English, and e) ability to use an electronic device such as a smartphone, computer, or tablet. After baseline measures, 32 participants will be randomized into two groups: one receiving both the brief 4-week online MBCT intervention and usual care (Experimental Group), the other one receiving solely one standardized educational online session with weekly reminders and usual care (Attention Control Group). Peer-reviewed competitive funding was received from the Florida State University’s Council on Research and Creativity in January 2021 as well as research ethics approval. RESULTS Recruitment has started in June 2021. CONCLUSIONS This research is significant because it targets the trajectory of CPSP, a leading cause of disability and opioid misuse. It is the first study to assess MBCT for the prevention of CPSP after cardiac surgery in the recovery phase. This approach is innovative because it promotes pain self-management through the modulation of individual factors. If successful, the intervention could be expanded to numerous populations at risk for chronic pain. CLINICALTRIAL NCT04848428

scholarly journals Evaluation of FindMyApps: protocol for a randomized controlled trial of the effectiveness and cost-effectiveness of a tablet-based intervention to improve self-management and social participation of community-dwelling people with mild dementia, compared to usual tablet use

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
David Peter Neal ◽  
Yvonne J. F. Kerkhof ◽  
Teake P. Ettema ◽  
Majon Muller ◽  
Judith Bosmans ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Social Participation ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Self Management ◽  
Tablet Computer ◽  
Randomized Controlled ◽  
People With Dementia

Abstract Background For the rising number of people living with dementia, cost-effective community-based interventions to support psychosocial care are needed. The FindMyApps intervention has been developed with and for people with dementia and their caregivers, to help them use tablets to facilitate self-management and engagement in meaningful social activities. A feasibility study and exploratory pilot trial evaluating FindMyApps have been carried out. This definitive trial further evaluates the effectiveness of the intervention and, for the first time, the cost-effectiveness. Methods A randomized controlled non-blinded single-center two-arm superiority trial will be conducted. Community-dwelling people with Mild Cognitive Impairment (MCI), or dementia with a Mini Mental-State Examination (MMSE) of > 17 and < 26, or Global Deterioration Scale 3 or 4, with an informal caregiver and access to a wireless internet connection will be included. In total, 150 patient-caregiver dyads will be randomly allocated to receive either usual care (control arm – tablet computer; n = 75 dyads) or usual care and the FindMyApps intervention (experimental arm – tablet computer and FindMyApps; n = 75 dyads). The primary outcomes are: for people with dementia, self-management and social participation; for caregivers, sense of competence. In addition to a main effect analysis, a cost-effectiveness analysis will be performed. In line with MRC guidance for evaluation of complex interventions a process evaluation will also be undertaken. Discussion Results of the trial are expected to be available in 2023 and will be submitted for publication in international peer-reviewed scientific journals, in addition to conference presentations and reporting via the EU Marie Sklodowska-Curie DISTINCT ITN network. By providing evidence for or against the effectiveness and cost-effectiveness of the FindMyApps intervention, the results of the trial will influence national implementation of FindMyApps. We hope that the results of the trial will further stimulate research and development at the intersection of technology and psycho-social care in dementia. We hope to further demonstrate that the randomized controlled trial is a valuable and feasible means of evaluating new digital technologies, to stimulate further high-quality research in this growing field. Trial registration number Netherlands Trial Register: NL8157; registered 15th November 2019.

scholarly journals The Effectiveness of Web-Based Asthma Self-Management System, My Asthma Portal (MAP): A Pilot Randomized Controlled Trial

2016 ◽  
Vol 18 (12) ◽  
pp. e313 ◽  
Author(s):  
Sara Ahmed ◽  
Pierre Ernst ◽  
Susan J Bartlett ◽  
Marie-France Valois ◽  
Tasneem Zaihra ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Management System ◽  
Controlled Trial ◽  
Self Management ◽  
Web Based ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

scholarly journals Smartphone Cardiac Rehabilitation, Assisted Self-Management Versus Usual Care: Protocol for a Multicenter Randomized Controlled Trial to Compare Effects and Costs Among People With Coronary Heart Disease (Preprint)

2019 ◽  
Author(s):  
Jonathan Charles Rawstorn ◽  
Kylie Ball ◽  
Brian Oldenburg ◽  
Clara K Chow ◽  
Sarah A McNaughton ◽  
...  
Keyword(s):  
Health Care ◽  
Coronary Heart Disease ◽  
Randomized Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Management ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Delivery Models

BACKGROUND Alternative evidence-based cardiac rehabilitation (CR) delivery models that overcome significant barriers to access and delivery are needed to address persistent low utilization. Models utilizing contemporary digital technologies could significantly improve reach and fidelity as complementary alternatives to traditional center-based programs. OBJECTIVE The aim of this study is to compare the effects and costs of the innovative <i>Smartphone Cardiac Rehabilitation, Assisted self-Management</i> (SCRAM) intervention with usual care CR. METHODS In this investigator-, assessor-, and statistician-blinded parallel 2-arm randomized controlled trial, 220 adults (18+ years) with coronary heart disease are being recruited from 3 hospitals in metropolitan and regional Victoria, Australia. Participants are randomized (1:1) to receive advice to engage with usual care CR or the SCRAM intervention. SCRAM is a 24-week dual-phase intervention that includes 12 weeks of real-time remote exercise supervision and coaching from exercise physiologists, which is followed by 12 weeks of data-driven nonreal-time remote coaching via telephone. Both intervention phases include evidence- and theory-based multifactorial behavior change support delivered via smartphone push notifications. Outcomes assessed at baseline, 12 weeks, and 24 weeks include maximal aerobic exercise capacity (primary outcome at 24 weeks), modifiable cardiovascular risk factors, exercise adherence, secondary prevention self-management behaviors, health-related quality of life, and adverse events. Economic and process evaluations will determine cost-effectiveness and participant perceptions of the treatment arms, respectively. RESULTS The trial was funded in November 2017 and received ethical approval in June 2018. Recruitment began in November 2018. As of September 2019, 54 participants have been randomized into the trial. CONCLUSIONS The innovative multiphase SCRAM intervention delivers real-time remote exercise supervision and evidence-based self-management behavioral support to participants, regardless of their geographic proximity to traditional center-based CR facilities. Our trial will provide unique and valuable information about effects of SCRAM on outcomes associated with cardiac and all-cause mortality, as well as acceptability and cost-effectiveness. These findings will be important to inform health care providers about the potential for innovative program delivery models, such as SCRAM, to be implemented at scale, as a complement to existing CR programs. The inclusion of a cohort comprising metropolitan-, regional-, and rural-dwelling participants will help to understand the role of this delivery model across health care contexts with diverse needs. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ACTRN): 12618001458224; anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374508. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15022

scholarly journals Delivery of Peer Support Through a Self-Management mHealth Intervention (Healing Circles) in Patients With Cardiovascular Disease: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Brodie M Sakakibara ◽  
Santabhanu Chakrabarti ◽  
Andrew Krahn ◽  
Martha H Mackay ◽  
Tara Sedlak ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Peer Support ◽  
Controlled Trial ◽  
Health Care Use ◽  
Self Management ◽  
Mhealth Intervention ◽  
Randomized Controlled ◽  
Questionnaire Version

BACKGROUND Cardiovascular disease (CVD) is a leading cause of hospitalization and death around the world. The prevalence of CVD is increasing and, therefore, development and investigation of effective programs to help people better self-manage their CVD and prevent secondary complications are needed. OBJECTIVE In this paper, we report on a protocol to evaluate Healing Circles—an evidence-based and patient-informed peer support mobile health program designed to facilitate self-management and support patients in their recovery from and management of CVD. We hypothesize that individuals with CVD who use Healing Circles will experience greater improvements to their self-management ability than individuals receiving usual care. METHODS In this single-blinded (assessor) randomized controlled trial, 250 community-living individuals with CVD will be randomized on a 1:1 basis to either Healing Circles or Usual Care. The primary outcome of self-management will be measured using the Health Education Impact Questionnaire version 3.0. Secondary outcomes include self-efficacy with chronic disease management, health-related quality of life, health resource use and costs, and electronic health literacy. Measurements will be taken at the baseline and every 6 months for 24 months. RESULTS The study started recruitment in September 2017. Individuals are currently being recruited for participation, and existing participants are currently on follow-up. Measurements will be taken every 6 months until the study end, which is anticipated in December 2019. CONCLUSIONS Healing Circles is a novel program aimed toward improving self-management through peer support. Given our real-world study design, our findings will be readily translatable into practice. If the results support our hypothesis, it will indicate that Healing Circles is an effective intervention for improving self-management and reducing health care use. CLINICALTRIAL ClinicalTrials.gov NCT03159325; https://clinicaltrials.gov/ct2/show/NCT03159325 (Archived by WebCite at http://www.webcitation.org/74DvxVKUd) INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12322

scholarly journals Feasibility of a Hybrid Web-Based and In-Person Self-management Intervention Aimed at Preventing Acute to Chronic Pain Transition After Major Lower Extremity Trauma (iPACT-E-Trauma): A Pilot Randomized Controlled Trial

Pain Medicine ◽  
2019 ◽  
Vol 20 (10) ◽  
pp. 2018-2032 ◽  
Author(s):  
M Bérubé ◽  
C Gélinas ◽  
N Feeley ◽  
G Martorella ◽  
J Côté ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Pain Catastrophizing ◽  
Controlled Trial ◽  
Self Management ◽  
Anxiety And Depression ◽  
Management Intervention ◽  
Randomized Controlled ◽  
Extremity Trauma ◽  
Experimental Group ◽  
Pilot Randomized Controlled Trial

Abstract Objective 1) To assess the feasibility of research methods to test a self-management intervention aimed at preventing acute to chronic pain transition in patients with major lower extremity trauma (iPACT-E-Trauma) and 2) to evaluate its potential effects at three and six months postinjury. Design A pilot randomized controlled trial (RCT) with two parallel groups. Setting A supraregional level 1 trauma center. Methods Fifty-six adult patients were randomized. Participants received the intervention or an educational pamphlet. Several parameters were evaluated to determine the feasibility of the research methods. The potential efficacy of iPACT-E-Trauma was evaluated with measures of pain intensity and pain interference with activities. Results More than 80% of eligible patients agreed to participate, and an attrition rate of ≤18% was found. Less than 40% of screened patients were eligible, and obtaining baseline data took 48 hours postadmission on average. Mean scores of mild pain intensity and pain interference with daily activities (<4/10) on average were obtained in both groups at three and six months postinjury. Between 20% and 30% of participants reported moderate to high mean scores (≥4/10) on these outcomes at the two follow-up time measures. The experimental group perceived greater considerable improvement in pain (60% in the experimental group vs 46% in the control group) at three months postinjury. Low mean scores of pain catastrophizing (Pain Catastrophizing Scale score < 30) and anxiety and depression (Hospital Anxiety and Depression Scale scores ≤ 10) were obtained through the end of the study. Conclusions Some challenges that need to be addressed in a future RCT include the small proportion of screened patients who were eligible and the selection of appropriate tools to measure the development of chronic pain. Studies will need to be conducted with patients presenting more serious injuries and psychological vulnerability or using a stepped screening approach.

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