scholarly journals The online delivery of exercise oncology classes supported with health coaching: A pilot randomized controlled trial

2021 ◽  
Author(s):  
Maximilian Eisele ◽  
Rosemary Twomey ◽  
Andrew J. Pohl ◽  
Meghan H. McDonough ◽  
Margaret L. McNeely ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Primary Objective ◽  
Recruitment Rate ◽  
Health Coaching ◽  
Attrition Rate ◽  
Structured Interviews ◽  
Online Delivery ◽  
Supervised Exercise ◽  
Exercise Oncology ◽  
Synchronous Online

Purpose: The primary objective was to investigate the feasibility of a synchronous, online delivered, group-based, supervised, exercise oncology maintenance program supported with health coaching. Methods: All participants had previously completed a 12-week group-based exercise study. In the current study, participants were randomized to a 12-week exercise oncology maintenance class with or without health coaching. The primary outcome was feasibility, assessed as intervention attendance, safety and fidelity, study recruitment, attrition and outcome assessment completion. Additionally, semi-structured interviews at the end of the intervention provided participants' perspectives on intervention feasibility. Results: Forty participants (n8WK=25; n12WK=15) enrolled in the study. Feasibility was confirmed for recruitment rate (42.6%), attrition rate (2.5%), safety (no adverse events), health coaching attendance (97%), health coaching fidelity (96.7%), class attendance (91.2%), class fidelity (92.6%), and assessment completion (questionnaire=98.8%; physical functioning=97.5%). Based on the qualitative feedback, feasibility was facilitated by the convenience, while the diminished ability to connect with other participants online was a drawback compared to in-person delivery. Conclusion: The synchronous online delivery of an exercise oncology maintenance class, the additional health coaching support, and the tools used to measure the intervention effectiveness were feasible for individuals living with and beyond cancer. Keywords health coaching, exercise, physical activity, maintenance, cancer survivors, online-delivery, mHealth

scholarly journals P125: Low dose intravenous ketorolac in renal colic, a pilot randomized controlled trial

CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S109-S110
Author(s):  
J. Chao ◽  
P. Brasher ◽  
K. Cheung ◽  
R. Sharma ◽  
K. Badke ◽  
...  
Keyword(s):  
Dose Group ◽  
Low Dose ◽  
Renal Colic ◽  
Standard Dose ◽  
Controlled Trial ◽  
Pain Reduction ◽  
Primary Objective ◽  
Recruitment Rate ◽  
Convenience Sample ◽  
Increased Risk

Introduction: Non-steroidal anti-inflammatory drugs (NSAIDs) are first-line analgesics for emergency department (ED) patients with renal colic. Lower doses of intravenous (IV) ketorolac may provide similar pain relief to standard dosing in patients with acute pain. Patients with renal colic may be at increased risk of acute kidney injury; exposing them to lower doses of NSAIDs may put them at lower risk while providing equally effective analgesia. We conducted a pilot study to determine the feasibility of a randomized trial comparing the effectiveness and safety of low with standard ketorolac dosing in ED patients with suspected renal colic. The primary objective was to demonstrate the ability to achieve an enrolment target of 2 patients per week. Methods: We enrolled a convenience sample of adults presenting to an academic urban ED with unilateral flank pain suspected to be renal colic. We randomized patients to 10 mg (low dose, intervention) or 30 mg (standard dose, control). Participants, treating physicians and nurses, and researchers were blinded to treatment allocation. Our main feasibility outcome was the recruitment rate. Secondary outcomes were changes in pain scores (0-10) at 30 and 120 minutes post-ketorolac administration, vital signs, adverse events and ED length of stay. Results: We approached 82 patients, of whom 47 (57.3%) were eligible. Of these, 36 consented to participating and 30 were randomized. The proportion of screened patients who were enrolled was 36.6% (30/82). We completed enrolment over a 21-week period, with an average recruitment rate of 1.5 patients/week (range 0-4). The average baseline pain score for all participants was 6.9 (SD = 2.1). At 30 minutes post-ketorolac administration, the low dose group had a mean pain reduction of 2.0 points compared to a pain reduction of 1.7 in standard dose group (difference = 0.3, 90% CI: -0.7 to 1.4). Conclusion: These preliminary results support the possibility that low dose ketorolac may be efficacious in this patient population. We did not meet our target recruitment of 2 patients per week as this was primarily due to restricted recruitment hours. To successfully conduct a larger trial, we would need to expand both recruitment hours and the number of sites.

scholarly journals Protocol for a factorial randomised controlled trial, embedded within WHiTE 8 COPAL, of an Enhanced Trainee Principal Investigator Package and Additional Digital Nudge to increase recruitment rates

F1000Research ◽  
2019 ◽  
Vol 8 ◽  
pp. 1153 ◽  
Author(s):  
Nickil Agni ◽  
Caroline Fairhurst ◽  
Catriona McDaid ◽  
Mike Reed ◽  
David Torgerson
Keyword(s):  
Randomised Controlled Trial ◽  
Positive Reinforcement ◽  
Controlled Trial ◽  
Significant Proportion ◽  
Educational Programme ◽  
Primary Objective ◽  
Recruitment Rate ◽  
Principal Investigators ◽  
Link Type ◽  
Randomised Controlled

Recruitment remains an issue when conducting randomised controlled trials (RCTs) with a significant proportion of studies failing to reach their target sample size. Studies evaluating interventions to improve recruitment aimed specifically at recruiters to the trial are limited in number. This factorial RCT will evaluate the effectiveness of an educational intervention to trainee principal investigators and a positive reinforcement intervention via an email nudge on increasing recruitment. The targeted recruiters will be in 20 centres nationally recruiting to one large orthopaedic randomised controlled trial, WHiTE 8 COPAL. Centres will be randomised via minimisation to one of four groups. The primary outcome is recruitment rate in the first six months that a centre is actively recruiting, with data being analysed via a Poisson regression model. Results will be presented as adjusted incidence rate ratios with 95% confidence intervals. Secondary outcomes relate to the feasibility and logistics of running the interventions.  We will also collect feedback regarding the educational programme set out for the trainee principal investigators. The study started in August 2018 with the anticipation of the primary objective endpoint by October 2019. The results of this study will be used to inform the design of future RCTs, particularly in orthopaedics in the UK, where the role of Trainee Principal Investigators is now a consistent one across different trials. Trial registration: 11600053, ISRCTN, 20/08/2018; SWAT 67, Northern Ireland Hub for Trials Methodology Research SWAT repository, 01/10/2017.

scholarly journals Promoting independence in dementia: protocol for a feasibility trial of the PRIDE intervention for living well with dementia

2018 ◽  
Vol 5 (4) ◽  
pp. 177 ◽  
Author(s):  
Emese Csipke ◽  
Lauren Yates ◽  
Esme Moniz Cook ◽  
Phuong Leung ◽  
Georgina Charlesworth ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Recruitment Rate ◽  
Feasibility Trial ◽  
Measure Data ◽  
Structured Interviews ◽  
Post Intervention ◽  
Mild Dementia ◽  
Living Well ◽  
People With Dementia ◽  
Randomised Controlled

<p class="abstract"><strong>Background:</strong> Dementia can lead to social exclusion, loss of identity and independence, due to deterioration in cognition and activities of daily living. The aim of the study is to investigate the feasibility of the Promoting Independence in Dementia (PRIDE) intervention, designed to facilitate independence in people with mild dementia.</p><p class="abstract"><strong>Methods:</strong> This is a mixed-methods feasibility trial of the PRIDE, in preparation for a future randomised controlled trial. Up to 50 people with dementia will be recruited. Demetia advisors will deliver the three session intervention. Quantitative outcomes will be taken at baseline and up to three months post baseline. Fidelity checklists will assess fidelity to the intervention. Qualitative implementation data will be gathered in a series of post-intervention semi-structured interviews with staff and participants. This will include data to examine participant experiences of and engagement with the intervention, and other aspects of delivery such as recruitment of DAWs, fidelity and experiences of receiving and delivering the intervention. This study aims to establish and field test the PRIDE intervention; determine the recruitment rate of sites, providers and participants; assess fidelity in delivery of the intervention and engagement with people with dementia; assess the feasibility and acceptability of outcome measure data and assess the acceptability of the intervention by stakeholders.</p><p class="abstract"><strong>Conclusions: </strong>There has been increased need for non-pharmacological interventions for mild dementia. The results of this feasibility study will allow us to plan for a definitive RCT of a three session dementia advisor led intervention for mild dementia.</p>

scholarly journals Feasibility and Preliminary Efficacy of a Foot-Ankle Exercise Program Aiming to Improve Foot-Ankle Functionality and Gait Biomechanics in People with Diabetic Neuropathy: A Randomized Controlled Trial

Sensors ◽  
2020 ◽  
Vol 20 (18) ◽  
pp. 5129
Author(s):  
Renan L. Monteiro ◽  
Jane S.S.P. Ferreira ◽  
Érica Q. Silva ◽  
Asha Donini ◽  
Ronaldo H. Cruvinel-Júnior ◽  
...  
Keyword(s):  
Diabetic Neuropathy ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Program ◽  
Recruitment Rate ◽  
Activity Level ◽  
Foot Health ◽  
Supervised Exercise ◽  
Over Time

Foot-ankle strengthening and mobility exercises are part of international guideline recommendations for people at risk of diabetic foot disease. We examined the feasibility and preliminary efficacy of a 12-week foot-ankle exercise program on clinical, functional and biomechanical outcomes in people with diabetic neuropathy (DPN). We randomly allocated 30 people with DPN to usual care (control) or usual care plus a supervised exercise program (intervention). For feasibility, we assessed recruitment rate and participant adherence and satisfaction. For program efficacy, we assessed baseline to 12-week changes in daily physical activity level, gait speed, tactile sensitivity, ankle range of motion, DPN symptoms, quality of life, foot health and functionality, foot strength and plantar pressure during gait, using paired t-tests (p < 0.05). In 52 weeks, we recruited 45 eligible participants (0.90/week). Program adherence was 80% and participants’ satisfaction had a mean (SD) of 4.57 (0.70) out of 5. The intervention group significantly improved on toes strength, contact time during gait and DPN symptoms, and peak forefoot pressures increased over time; controls showed significantly increased heel peak pressures and force. The exercise program was feasible, based on a moderate recruitment rate and an adherent and satisfied population, and the intervention showed several positive preliminary effects over time compared to usual care.

A simplified 10-step Tai-chi programme to enable people with dementia to improve their motor performance: a feasibility study

2018 ◽  
Vol 32 (12) ◽  
pp. 1609-1623 ◽  
Author(s):  
Justina Yat Wa Liu ◽  
Rick Yiu Cho Kwan ◽  
Claudia KY Lai ◽  
Keith D Hill
Keyword(s):  
Family Caregivers ◽  
Motor Performance ◽  
Tai Chi ◽  
Controlled Trial ◽  
Training Programme ◽  
Recruitment Rate ◽  
Attrition Rate ◽  
Control Group ◽  
Feasibility Assessment ◽  
People With Dementia

Objective: To evaluate the feasibility and preliminary effects of a simplified 10-step Tai-chi programme to improve the motor performance of people with dementia. Design: A two-arm, single-blinded cluster randomized controlled trial, registered with ClinicalTrials.gov (NCT03341091). Setting: Community health centres. Participants: Twenty-six dyads of people with dementia and their family caregivers were recruited, with mean (SD) ages of 82.2 (7.43) and 51.3 (18.97), respectively. Interventions: The experimental group underwent a 16 week 10-step simplified Tai-chi training programme, with additional measures to enhance engagement. The control group joined recreational activities organized by the centres. Main outcome measure(s): The feasibility assessment included recruitment, attrition, adherence to, and engagement in the Tai-chi programme. The preliminary effects were assessed by the participants’ performance in mobility tests. Results: Preliminary feasibility was established, with an acceptable recruitment rate of 58% (26 out of 45 assessed dyads) and a high attendance rate of 81% (25.88 out of 32 Tai-chi sessions). There was positive engagement in the training sessions, and no adverse incidents. However, five participants withdrew from the Tai-chi group, for a high attrition rate of 38%, and the mean home practice time decreased between weeks 8 and 16. In most of the motor performance tests, a slight but insignificant improvement was observed in the Tai-chi group compared to the control group. Conclusion: A tailored Tai-chi programme for people with dementia using a dyadic approach has been found to be feasible. However, stronger support must be provided to family caregivers to improve the participants’ sustained participation.

scholarly journals Promoting physical activity in regional and remote cancer survivors (PPARCS) using wearables and health coaching: randomised controlled trial protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e028369 ◽  
Author(s):  
Sarah J Hardcastle ◽  
Dana Hince ◽  
Ruth Jiménez-Castuera ◽  
Terry Boyle ◽  
Vinicius Cavalheri ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cancer Survivors ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Controlled Trial ◽  
Survival Rates ◽  
Intervention Group ◽  
Primary Objective ◽  
Health Coaching ◽  
Control Group

IntroductionPhysically active cancer survivors have substantially less cancer recurrence and improved survival compared with those who are inactive. However, the majority of survivors (70%–90%) are not meeting the physical activity (PA) guidelines. There are also significant geographic inequalities in cancer survival with poorer survival rates for the third of Australians who live in non-metropolitan areas compared with those living in major cities. The primary objective of the trial is to increase moderate-to-vigorous PA (MVPA) among cancer survivors living in regional and remote Western Australia. Secondary objectives are to reduce sedentary behaviour and in conjunction with increased PA, improve quality of life (QoL) in non-metropolitan survivors. Tertiary objectives are to assess the effectiveness of the health action process approach (HAPA) model variables, on which the intervention is based, to predict change in MVPA.Methods and analysisEighty-six cancer survivors will be randomised into either the intervention or control group. Intervention group participants will receive a Fitbit and up to six telephone health-coaching sessions. MVPA (using Actigraph), QoL and psychological variables (based on the HAPA model via questionnaire) will be assessed at baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up). A general linear mixed model will be used to assess the effectiveness of the intervention.Ethics and disseminationEthics approval has been obtained from St John of God Hospital Subiaco (HREC/#1201). We plan to submit a manuscript of the results to a peer-reviewed journal. Results will be presented at conferences, community and consumer forums and hospital research conferences.Trial registration numberACTRN12618001743257; pre-results, U1111-1222-5698

scholarly journals Testing a newly developed activity pacing framework for chronic pain/fatigue: a feasibility study

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e045398
Author(s):  
Deborah Antcliff ◽  
Anne-Maree Keenan ◽  
Philip Keeley ◽  
Steve Woby ◽  
Linda McGowan
Keyword(s):  
Chronic Pain ◽  
Repeated Measures ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Chronic Fatigue ◽  
Chronic Widespread Pain ◽  
Recruitment Rate ◽  
Rehabilitation Programme ◽  
Attrition Rate ◽  
T1 And T2

ObjectivesTo test the feasibility of using a new activity pacing framework to standardise healthcare professionals’ instructions of pacing, and explore whether measures of activity pacing/symptoms detected changes following treatment.DesignSingle-arm, repeated measures study.SettingOne National Health Service (NHS) Pain Service in Northern England, UK.ParticipantsAdult patients with chronic pain/fatigue, including chronic low back pain, chronic widespread pain, fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis.InterventionsSix-week rehabilitation programme, standardised using the activity pacing framework.Outcome measuresFeasibility was explored via patients’ recruitment/attrition rates, adherence and satisfaction, and healthcare professionals’ fidelity. Questionnaire data were collected from patients at the start and end of the programme (T1 and T2, respectively) and 3 months’ follow-up (T3). Questionnaires included measures of activity pacing, current/usual pain, physical/mental fatigue, depression, anxiety, self-efficacy, avoidance, physical/mental function and quality of life. Mean changes in activity pacing and symptoms between T1-T2, T2-T3 and T1-T3 were estimated.ResultsOf the 139 eligible patients, 107 patients consented (recruitment rate=77%); 65 patients completed T2 (T1-T2 attrition rate=39%), and 52 patients completed T3 (T1-T3 attrition rate=51%). At T2, patients’ satisfaction ratings averaged 9/10, and 89% attended ≥5 rehabilitation programme sessions. Activity pacing and all symptoms improved between T1 and T2, with smaller improvements maintained at T3.ConclusionThe activity pacing framework was feasible to implement and patients’ ability to pace and manage their symptoms improved. Future work will employ a suitable comparison group and test the framework across wider settings to explore the effects of activity pacing in a randomised controlled trial.Trial registration numberNCT03497585.

Barriers to Supervised Exercise Training in a Randomized Controlled Trial of Breast Cancer Patients Receiving Chemotherapy

2008 ◽  
Vol 35 (1) ◽  
pp. 116-122 ◽  
Author(s):  
Kerry S. Courneya ◽  
Donald C. McKenzie ◽  
Robert D. Reid ◽  
John R. Mackey ◽  
Karen Gelmon ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Exercise Training ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Breast Cancer Patients ◽  
Randomized Controlled ◽  
Supervised Exercise

scholarly journals Reluctance to Accept Palliative Care and Recommendations for Improvement: Findings From Semi-Structured Interviews With Patients and Caregivers

2021 ◽  
pp. 104990912110126
Author(s):  
Valeria Cardenas ◽  
Anna Rahman ◽  
Yujun Zhu ◽  
Susan Enguidanos
Keyword(s):  
Palliative Care ◽  
Controlled Trial ◽  
Insurance Coverage ◽  
Healthcare Providers ◽  
Health Condition ◽  
Insurance Companies ◽  
Structured Interviews ◽  
Care Services ◽  
Home Based ◽  
Palliative Care Services

Background: Despite some insurance plans now paying for home-based palliative care, recent reports have suggested that insurance coverage for palliative care may be insufficient in expanding patient access to home-based palliative care. Aim: To identify patients’ and caregivers’ perceived barriers to home-based palliative care and their recommendations for overcoming these barriers. Design: We conducted a qualitative study using semi-structured individual interviews. Our interview protocol elicited participants’ perspectives on home-based palliative care services; positive and negative aspects of the palliative program explanation; and suggestions for improving messaging around home-based palliative care. Setting/Participants: Twenty-five participants (patients, proxies, and their caregivers) who were eligible for a randomized controlled trial of home-based palliative care were interviewed by telephone. Results: Themes related to home-based palliative care referral barriers included reluctance to have home visits, enrollment timing, lack of palliative care knowledge, misconceptions about palliative care, and patients’ self-perceived health condition. Themes related to recommendations for overcoming these obstacles included ensuring that palliative care referrals come from healthcare providers or insurance companies and presenting palliative care services more clearly. Conclusion: Findings reinforce the need for additional palliative care education among patients with serious illness (and their caregivers) and the importance of delivering palliative care information and referrals from trusted sources.

scholarly journals Early combination therapy with etanercept and methotrexate in JIA patients shortens the time to reach an inactive disease state and remission: results of a double-blind placebo-controlled trial

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Ekaterina Alexeeva ◽  
Gerd Horneff ◽  
Tatyana Dvoryakovskaya ◽  
Rina Denisova ◽  
Irina Nikishina ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Controlled Trial ◽  
Randomized Study ◽  
Primary Objective ◽  
Disease State ◽  
Inactive Disease ◽  
Open Label ◽  
Standard Regimen ◽  
Double Blind ◽  
Early Combination Therapy

Abstract Background Remission is the primary objective of treating juvenile idiopathic arthritis (JIA). It is still debatable whether early intensive treatment is superior in terms of earlier achievement of remission. The aim of this study was to evaluate the effectiveness of early etanercept+methotrexate (ETA+MTX) combination therapy versus step-up MTX monotherapy with ETA added in refractory disease. Methods A multi-centre, double-blind, randomized study in active polyarticular JIA patients treated with either ETA+MTX (n = 35) or placebo+MTX (n = 33) for up to 24 weeks, followed by a 24-week open-label phase. The efficacy endpoints included pedACR30 criteria improvement at week 12, inactive disease at week 24, and remission at week 48. Patients who failed to achieve the endpoints at week 12 or at week 24 escaped to open-label ETA+MTX. Safety was assessed at each visit. Results By intention-to-treat analysis, more patients in the ETA+MTX group reached the pedACR30 response at week 12 (33 (94.3%)) than in the placebo+MTX group (20 (60.6%); p = 0.001). At week 24, comparable percentages of patients reached inactive disease (11 (31.4%) vs 11 (33.3%)). At week 48, 11 (31.4%) and eight (24.2%) patients achieved remission. The median (+/−IQR) times to achieve an inactive disease state in the ETA+MTX and placebo+MTX groups were 24 (14–32) and 32 (24–40) weeks, respectively. Forty-four (74/100 patient-years) adverse events (AEs) were reported, leading to treatment discontinuation in 6 patients. Conclusions Early combination therapy with ETA+MTX proved to be highly effective compared to the standard step-up regimen. Compared to those treated with the standard regimen, more patients treated with a combination of ETA+MTX reached the pedACR30 response and achieved inactive disease and remission more rapidly.

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