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.

scholarly journals A Hybrid Web-Based and In-Person Self-Management Intervention Aimed at Preventing Acute to Chronic Pain Transition After Major Lower Extremity Trauma: Feasibility and Acceptability of iPACT-E-Trauma (Preprint)

2018 ◽  
Author(s):  
Mélanie Bérubé ◽  
Céline Gélinas ◽  
Nancy Feeley ◽  
Géraldine Martorella ◽  
José Côté ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Lower Extremity ◽  
Controlled Trial ◽  
Self Management ◽  
Relaxation Techniques ◽  
Web Based ◽  
Management Intervention ◽  
Lower Extremity Trauma ◽  
Extremity Trauma ◽  
The Web

BACKGROUND A transition from acute to chronic pain frequently occurs after major lower extremity trauma. While the risk factors for developing chronic pain in this population have been extensively studied, research findings on interventions aiming to prevent chronic pain in the trauma context are scarce. Therefore, we developed a hybrid, Web-based and in-person, self-management intervention to prevent acute to chronic pain transition after major lower extremity trauma (iPACT-E-Trauma). OBJECTIVE This study aimed to assess the feasibility and acceptability of iPACT-E-Trauma. METHODS Using a descriptive design, the intervention was initiated at a supra-regional level-1 trauma center. Twenty-eight patients ≥18 years old with major lower extremity trauma, presenting with moderate to high pain intensity 24 hours post-injury were recruited. Feasibility assessment was two-fold: 1) whether the intervention components could be provided as planned to ≥80% of participants and 2) whether ≥80% of participants could complete the intervention. The rates for both these variables were calculated. The E-Health Acceptability Questionnaire and the Treatment Acceptability and Preference Questionnaire were used to assess acceptability. Mean scores were computed to determine the intervention’s acceptability. RESULTS More than 80% of participants received the session components relevant to their condition. However, the Web pages for session 2, on the analgesics prescribed, were accessed by 71% of participants. Most sessions were delivered according to the established timeline for ≥80% of participants. Session 3 and in-person coaching meetings had to be provider earlier for ≥35% of participants. Session duration was 30 minutes or less on average, as initially planned. More than 80% of participants attended sessions and <20% did not apply self-management behaviors relevant to their condition, with the exception of deep breathing relaxation exercises which was not applied by 40% of them. Web and in-person sessions were assessed as very acceptable (mean scores ≥3 on a 0 to 4 descriptive scale) across nearly all acceptability attributes. CONCLUSIONS Findings showed that the iPACT-E-Trauma intervention is feasible and was perceived as highly acceptable by participants. Further tailoring iPACT-E-Trauma to patient needs, providing more training time for relaxation techniques, and modifying the Web platform to improve its convenience could enhance the feasibility and acceptability of the intervention. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN): 91987302; http://www.controlled-trials.com/ISRCTN91987302 (Archived by WebCite at http://www.webcitation.org/6ynibjPHa)

scholarly journals Brief Video-Delivered Interventions to Reduce Anxiety in Older Veterans: A Pilot RCT

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 569-569
Author(s):  
Chalise Carlson ◽  
Lauren Anker ◽  
Ruth O'Hara ◽  
Julie Wetherell ◽  
Mary Goldstein ◽  
...  
Keyword(s):  
Anxiety Disorders ◽  
Anxiety Symptom ◽  
Controlled Trial ◽  
Self Management ◽  
Intervention Delivery ◽  
Management Intervention ◽  
Randomized Controlled ◽  
Longitudinal Effects ◽  
Pilot Rct ◽  
Pilot Randomized Controlled Trial

Abstract Older Veterans with anxiety disorders encounter barriers to receiving mental health services that may be overcome by using brief technology-delivered interventions. To address this, we conducted a pilot randomized controlled trial (RCT) comparing the effects of a guided self-management intervention called BREATHE, a 4-week video-delivered (DVD/internet) intervention and a psychoeducation control (Healthy Living; HL) on anxiety symptom severity. Older Veterans with anxiety disorders (N = 48; 87.5% men; Mean age = 71.77 ± 6.2 years) were randomized to BREATHE or HL. Regarding intervention delivery modality, 67% used DVDs, 23% used the internet, 4% used both to access their assigned intervention. Both groups experienced significant declines in affective anxiety from baseline to 8 weeks followed by an increase in symptoms (i.e., quadratic pattern). HL had significant declines in somatic anxiety, whereas BREATHE did not experience such declines. The longitudinal effects and Veteran satisfaction will be further described in the presentation.

An Internet-based Self-management Program with Telephone Support for Adolescents with Arthritis: A Pilot Randomized Controlled Trial

2010 ◽  
Vol 37 (9) ◽  
pp. 1944-1952 ◽  
Author(s):  
JENNIFER N. STINSON ◽  
PATRICK J. McGRATH ◽  
ELLEN D. HODNETT ◽  
BRIAN M. FELDMAN ◽  
CIARAN M. DUFFY ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Management Program ◽  
Self Management ◽  
The Internet ◽  
Telephone Support ◽  
Randomized Controlled ◽  
Phone Calls ◽  
Experimental Group ◽  
Pilot Randomized Controlled Trial ◽  
Disease Specific

Objective.To determine the feasibility of a 12-week Internet-based self-management program of disease-specific information, self-management strategies, and social support with telephone support for youth with juvenile idiopathic arthritis (JIA) and their parents, aimed at reducing physical and emotional symptoms and improving health-related quality of life (HRQOL).Methods.A nonblind pilot randomized controlled trial (NCT01011179) was conducted to test the feasibility of the “Teens Taking Charge: Managing Arthritis Online” Internet intervention across 4 tertiary-level centers in Canada. Participants were 46 adolescents with JIA, ages 12 to 18 years, and 1 parent for each participant, who were randomized to the control arm (n = 24) or the Internet intervention (n = 22).Results.The 2 groups were comparable on demographic and disease-related variables and treatment expectation at baseline. Attrition rates were 18.1% and 20.8%, respectively, from experimental and control groups. Ninety-one percent of participants randomized to the experimental group completed all 12 online modules and weekly phone calls with a coach in an average of 14.7 weeks (SD 2.1). The control group completed 90% of weekly attention-control phone calls. The Internet treatment was rated as acceptable by all youth and their parents. In posttreatment the experimental group had significantly higher knowledge (p < 0.001, effect size 1.32) and lower average weekly pain intensity (p = 0.03, effect size 0.78). There were no significant group differences in HRQOL, self-efficacy, adherence, and stress posttreatment.Conclusion.Findings support the feasibility (acceptability, compliance, and user satisfaction) and initial efficacy of Internet delivery of a self-management program for improving disease-specific knowledge and reducing pain in youth with JIA.

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 The effectiveness of nurse-led self-management support program for people with chronic kidney disease stage 3-4 (CKD-NLSM): Study protocol for a randomized controlled trial

2021 ◽  
Vol 104 (2) ◽  
pp. 003685042110261
Author(s):  
Al Sawad Ayat Ali ◽  
Soo Kun Lim ◽  
Li Yoong Tang ◽  
Aneesa Abdul Rashid ◽  
Boon-How Chew
Keyword(s):  
Kidney Disease ◽  
Controlled Trial ◽  
Self Management ◽  
Control Group ◽  
Management Support ◽  
Disease Knowledge ◽  
Management Intervention ◽  
Randomized Controlled ◽  
Ckd Stage ◽  
Management Behaviors

The complexity of chronic kidney disease (CKD) and its treatments have made self-management behaviors inevitably challenging. However, supplementing education with self-management skills may improve numerous health outcomes in people with nondialysis CKD. This study protocol describes a randomized controlled trial (RCT) aimed to evaluate the effects of a nurse-led self-management support program as an intervention for kidney disease knowledge and CKD self-management behaviors among people with pre-dialysis CKD. In Phase 1, people with CKD stage 3–4 and their family members are involved in co-designing, development and pilot testing of a theory-based self-management intervention. In Phase 2, we perform a cross-cultural adaptation of the Kidney Disease Knowledge Survey, CKD Self-Management and Self-efficacy for Managing Chronic Disease questionnaires. In Phase 3, a parallel RCT will be conducted to evaluate the intervention where 154 participants with CKD stage 3–4 will be randomly assigned to either the intervention ( n = 77) or control group ( n = 77). The intervention group will receive 6-week self-management program from a nurse-coach in addition to standard usual care, while the control group will receive only standard usual care. Outcome measures include kidney disease knowledge, CKD self-management behavior, self-efficacy, quality of life, blood pressure control and adherence to CKD diet as indicated by 24-h urine urea nitrogen, 24-h urine sodium and net endogenous acid production. Data will be collected at baseline and 12-week post-baseline. The between- and within-group intervention effects will be estimated using the Generalized Estimating Equations. The self-management intervention offers strategies to delay CKD progression and to encourage motivation to better self-manage at home. This study integrates self-management education and psychosocial support with culturally relevant scenarios, and evaluates important self-reported and objective outcomes. Clinical Trials Registration: www.ClinicalTrials.gov , identifier: NCT03974646.

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