A Development and Feasibility Study of a Peer Support Telephone Program in Rheumatoid Arthritis.
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ABSTRACT:
SUBMITTER: Shadick NA
PROVIDER: S-EPMC6699178 | biostudies-literature | 2018 Sep
REPOSITORIES: biostudies-literature
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A Development and Feasibility Study of a Peer Support Telephone Program in Rheumatoid Arthritis.
Shadick Nancy A NA Zibit Melanie J MJ Iannaccone Christine K CK Thrower Rebecca R Sowell Nancy F NF Weinblatt Michael E ME Solomon Daniel Hal DH Cui Jing J
Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases 20180901 6
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Project description:ObjectiveTofacitinib is an oral JAK inhibitor indicated for the treatment of rheumatoid arthritis (RA). We characterized lymphoma events in the tofacitinib RA clinical development program.MethodsLymphoma events (up to March 2015) were identified from 19 tofacitinib studies (2 phase I, 9 phase II, 6 phase III, and 2 long-term extension) of patients with moderate to severe RA. Patients in these studies received tofacitinib dosed at 1-30 mg twice daily or 20 mg once daily, as monotherapy or with conventional synthetic disease-modifying antirheumatic drugs. Lymphoma incidence rates (IRs; number of patients with events/100 patient-years) and standardized incidence ratios (SIRs) were calculated. A descriptive case-matched control analysis (1:4) was performed to identify potential risk factors for lymphoma.ResultsA total of 6,194 patients received tofacitinib (19,406 patient-years of exposure, 3.4 years median treatment duration). Nineteen lymphomas occurred (IR 0.10 [95% confidence interval (95% CI) 0.06-0.15]), with no increase observed with time of exposure. The age- and sex-adjusted SIR of lymphoma was 2.62 (95% CI 1.58-4.09) (Surveillance, Epidemiology, and End Results [SEER] program database). The clinical characteristics of the 19 lymphomas were typical for the RA population. Three lymphomas were positive for Epstein-Barr virus, 8 were negative, 2 were equivocal, and 6 were untested. Numerically, more lymphoma cases had a history of Sjögren's syndrome and were positive for anti-cyclic citrullinated protein and rheumatoid factor at baseline versus matched controls. The mean corticosteroid dose was higher for lymphoma cases versus controls.ConclusionIn the tofacitinib RA clinical development program, lymphoma rates were stable over time and there were minimal differences in the baseline characteristics of patients with and without lymphoma.
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Project description:BackgroundWhen experiencing mental distress, many university students seek support from their peers. In schools and mental health services, formalised peer support interventions have demonstrated some success but implementation challenges have been reported. This study aimed to assess the feasibility, acceptability and safety of a novel manualized peer support intervention and associated data collection processes.MethodsA longitudinal mixed methods study was conducted following the pilot of a peer support intervention at a large London university between June 2021 and May 2022. The study utilised data routinely recorded on all students who booked a peer support session, focus groups with nine peer workers and five staff members implementing the intervention, pre-post intervention surveys with 13 students and qualitative interviews with 10 of those students.Results169 bookings were made during the pilot, of which 130 (77%) were attended, with November the peak month. Staff and peer workers described strong motivation and commitment to implement the intervention, noting that the peer support model and peer worker role addressed previously unmet needs at the university. However, students described implementation problems relating to the coherence of the intervention and the burden of participation. While students mostly described acceptable experiences, there were examples where acceptability was lower. No adverse events were reported during the pilot.ConclusionThe training and supervision of peer workers, and the provision of one-to-one peer support to students was found to be feasible, mostly acceptable, and safe. However, sustained implementation difficulties were observed. These pose challenges to the scalability of peer support in universities. We make recommendations to improve implementation of peer support including improving reach, greater clarity about the intervention, and fuller involvement of students throughout.
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Project description:The long-term consequences of traumatic brain injury can create major barriers to community integration. Peer support represents a sustainable model of support across this transition. The objective of the current study was to determine the feasibility of conducting a randomized controlled trial on the Ontario Brain Injury Association Peer Support Program and the preliminary effectiveness of the program on community integration, mood, health-related quality of life, and self-efficacy; Methods: A pilot feasibility randomized controlled trial with an embedded qualitative component was conducted. Mentees with moderate-to-severe traumatic brain injury (n = 13) were randomized to a weekly intervention or waitlist control group. Interviews were conducted with a subset of mentees and peer mentors (n = 10). Integration of the quantitative and qualitative data was completed using a joint display approach; Results: No statistically significant results were found for community integration, mood, or self-efficacy; however, changes in these outcomes were accompanied by moderate-to-large effect sizes. Within health-related quality of life, the mean pain score of the intervention group was significantly lower than that of the control group at the two-month timepoint but not at completion. Interviews revealed proximal improvements in knowledge, skills, and goals, and identified two domains related to trial acceptability: (1) environmental context and resources, and (2) reinforcement; Conclusions: Given the conceivable importance of proximal improvements in domains such as knowledge, skills, and/or goals for the attainment of more distal outcomes, modifications to the existing Peer Support Program may be warranted. The introduction of program recommendations which promote discussion around particular domains may help facilitate long-term improvements in health outcomes.
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Project description:BackgroundChronic kidney disease (CKD) is a common, progressive condition. Lifestyle changes and antihypertensive medication can slow the progression to end-stage kidney disease, which requires renal replacement therapy. However, adherence to these recommendations is often low.ObjectiveThe aim of CareKnowDo was to assess the feasibility of rolling out a digital self-management support and adherence program integrated with a patient-facing electronic health record, Patient View (PV).MethodsA 2-arm, parallel, individual-level pragmatic feasibility pilot randomized controlled trial was conducted at 2 National Health Service (NHS) sites in the United Kingdom. A total of 61 patients with CKD were randomized 1:1 into 2 groups and provided with either a new, tailored digital and telephone support program (CareKnowDo: 31/61, 51%) integrated with PV or standard care (PV alone: 30/61, 49%). Quantitative measures included clinical and psychosocial measures. The primary outcomes were feasibility based: recruitment rate, dropout, and the exploration of associations.ResultsOf the 1392 patients screened in local kidney clinics, 269 (19.32%) met the basic inclusion criteria; the first 22.7% (61/269) who met the eligibility criteria were recruited to participate in the study. Of the 69 patients, 23 (38%) patients completed the final 6-month follow-up web-based survey. Reasons for the attrition were explored. A higher belief in the ability of the treatment to control CKD was associated with lower blood pressure at baseline (r=0.52; P=.005), and a higher perceived understanding of CKD at baseline was associated with lower blood pressure at follow-up (r=0.66; P<.001). Beliefs about medicines at baseline were associated with blood pressure at baseline but not at follow-up. This was true for both concerns about medicines (r=0.58; P=.001) and perceived necessity of medicines (r=0.42; P=.03).ConclusionsA tailored digital and nurse call-based program to enhance support for patients with CKD was piloted in 2 NHS sites and found to be feasible and acceptable. However, to maximize the effectiveness of the intervention (and of future trials), consideration should be given to the target audience most likely to benefit, as well as how to help them access the program as quickly and easily as possible.Trial registrationNHS Health Research Authority, IRAS ID 184206; https://www.hra.nhs.uk/planning-and-improving -research/application-summaries/research-summaries/careknowdo-pilot-version-1/.
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Project description:To examine the feasibility and potential benefits of early peer support to improve the health and quality of life of individuals with early inflammatory arthritis (EIA).Feasibility study using the 2008 Medical Research Council framework as a theoretical basis. A literature review, environmental scan, and interviews with patients, families and healthcare providers guided the development of peer mentor training sessions and a peer-to-peer mentoring programme. Peer mentors were trained and paired with a mentee to receive (face-to-face or telephone) support over 12 weeks.Two academic teaching hospitals in Toronto, Ontario, Canada.Nine pairs consisting of one peer mentor and one mentee were matched based on factors such as age and work status.Mentee outcomes of disease modifying antirheumatic drugs (DMARDs)/biological treatment use, self-efficacy, self-management, health-related quality of life, anxiety, coping efficacy, social support and disease activity were measured using validated tools. Descriptive statistics and effect sizes were calculated to determine clinically important (>0.3) changes. Peer mentor self-efficacy was assessed using a self-efficacy scale. Interviews conducted with participants examined acceptability and feasibility of procedures and outcome measures, as well as perspectives on the value of peer support for individuals with EIA. Themes were identified through constant comparison.Mentees experienced improvements in the overall arthritis impact on life, coping efficacy and social support (effect size >0.3). Mentees also perceived emotional, informational, appraisal and instrumental support. Mentors also reported benefits and learnt from mentees' fortitude and self-management skills. The training was well received by mentors. Their self-efficacy increased significantly after training completion. Participants' experience of peer support was informed by the unique relationship with their peer. All participants were unequivocal about the need for peer support for individuals with EIA.The intervention was well received. Training, peer support programme and outcome measures were demonstrated to be feasible with modifications. Early peer support may augment current rheumatological care.NCT01054963, NCT01054131.
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Project description:IntroductionPatients with rheumatoid arthritis (RA) who are treated with adalimumab (ADA) are offered a proprietary patient support program (PSP, AbbVie Care®). The main objective of this study was to examine the effectiveness of ADA on RA treatment course over time in the context of PSP utilization.MethodsPASSION was a 78-week post-marketing observational study of RA patients with an insufficient response to ≥1 DMARD newly initiating ADA in routine clinical care that was conducted in Europe, Israel, Mexico, Puerto Rico, and Australia. One prior biologic DMARD was allowed. The primary endpoint was percentage of patients achieving the minimal clinically important difference (MCID; improvement of ≥0.22 compared to baseline) in Health Assessment Questionnaire (HAQ) Disability Index (HAQ-DI) at week 78. Additionally, multiple clinical and patient-reported outcomes (PROs) were evaluated over time. Patients were categorized based on their participation in the PSP: ever (PSP users) vs. never (PSP non-users). Safety events were monitored throughout the study.ResultsOverall, 42.8% of PSP users achieved the MCID in HAQ-DI at week 78 (improvement of at least 0.22 compared to baseline). From 1025 enrolled, 48.7% of patients were PSP users while treated with ADA. The percentage of patients achieving MCID in the HAQ-DI was higher in PSP users vs. PSP non-users (48.1 vs. 37.8%) at week 78 (p < 0.001, NRI). Most of the studied clinical outcomes and PROs showed significant improvements (p < 0.05) from baseline to week 78 favoring PSP users over PSP non-users.ConclusionsIn patients with moderate-to-severe RA who initiated ADA, improvements in clinical, functional, and PROs were achieved in real-world settings with significantly greater improvements among PSP users in comparison with PSP non-users.FundingAbbVie.Trial registrationClinicalTrials.gov identifier, NCT01383421.
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Project description:BackgroundPsychological support programs can help nurses who involved in patient safety incidents. However, most of these programs are operated internally by healthcare providers and utilize peer supporters, which may take a long time to implement. Therefore, there is a need to develop programs that can be used by healthcare providers in healthcare institutions that have difficulty implementing their own programs. This feasibility study aimed to develop an external support program for nurses as second victims and to examine the feasibility, acceptability, and impact of the program.MethodsThis study was conducted using a single-group pretest-posttest design. Nurses who experienced patient safety incidents were recruited through posters at three advanced general hospitals, as well as open online recruitment and via a research agency panel from September 2020 to April 2021. The 11 participants attended a total of three one-on-one counseling sessions. Feasibility was evaluated based on participant recruitment and retention, resource availability, program procedures, and the practicability of data collection. Acceptability was assessed through program satisfaction and participant feedback. Psychological impact was measured using the Impact of Event Scale-Revised Korean version.ResultsOut of 26 applicants, 11 (42.3%) completed the program, with 10 (38.5%) participants completing both pre and post-program surveys. Most participants responded that they were satisfied with the program and expressed their intention to recommend the program to others and participate in it again if similar situations arise. The participants' median total IES-R-K score decreased significantly from 30.0 to 16.0 (p = 0.028, r = 0.67).ConclusionThis study demonstrates the feasibility of an external second victim support program and provides preliminary data suggesting its potential to alleviate the psychological impact of participants. To overcome the limitations of this study, it is necessary to conduct additional controlled trials with a longer follow-up period and a larger sample size.
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