Occupational Performance Coaching for Children With Neurodisability: A Randomized Controlled Trial Protocol.
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SUBMITTER: Graham FP
PROVIDER: S-EPMC10903119 | biostudies-literature | 2024 Mar
REPOSITORIES: biostudies-literature
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Occupational Performance Coaching for Children With Neurodisability: A Randomized Controlled Trial Protocol.
Graham Fiona P FP Williman Jonathan A JA Desha Laura N LN Snell Deborah D Jones Bernadette B Ingham Tristram R TR Latu Anna A Maggo Jasjot K JK Ranta Annemarei A Ziviani Jenny J
Canadian journal of occupational therapy. Revue canadienne d'ergotherapie 20230315 1
<b>Background.</b> Occupational Performance Coaching (OPC) is a goal-oriented approach in which client agency takes precedence in goal selection, analysis, choice of action, and evaluation of success. The intended outcomes of OPC are improved occupational performance and participation in clients' life situations. Randomized clinical trials are needed to determine the effectiveness of OPC. <b>Purpose.</b> This study protocol outlines a randomized controlled trial (RCT) of OPC compared to usual ca ...[more]
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Project description:BackgroundIn Australia, the average time between a first concern of autism spectrum disorder (ASD) and diagnosis is over 2 years. After referral for assessment, families often wait 6-12 months before their appointment. This can be a time of uncertainty and stress for families. For some families, other forms of assistance are not accessible and thus timely intervention opportunities are missed. There is little evidence about how to provide the best support for children or caregivers while on assessment waiting lists.ObjectiveThe aim of this study is to determine whether use of a coaching intervention called Occupational Performance Coaching (OPC) combined with service navigation support is feasible for families waiting for ASD assessment, as a crucial first step in planning a randomized controlled trial.MethodsA pilot and feasibility study will be conducted using recommended constructs and associated measures, which will be reported using CONSORT (Consolidated Standards or Reporting Trials) guidance. Participants will be child and caregiver dyads or triads, recruited within 4 months of their child (aged 1-7 years) being referred to one of two services for an ASD assessment in Victoria, Australia. A blinded randomization procedure will be used to allocate participants to one of three trial arms: (1) coaching and support intervention delivered face to face, (2) coaching and support intervention via videoconference, and (3) usual care. Descriptive statistics will be used to describe the sample characteristics of parents and children, inclusive of service access at baseline and follow up. Recruitment rates will be reported, and retention rates will be evaluated against a predicted rate of 70%-80% in each intervention arm. Goal attainment, using the Canadian Occupational Performance Measure, will indicate preliminary evidence for efficacy within the intervention arms, with an increase of 2 or more points on a 10-point performance and satisfaction scale considered clinically significant.ResultsThe study was approved by The Royal Children's Hospital Research Ethics and Governance Department in September 2018. As of October 2020, 16 families have been recruited to the study. Data analysis is ongoing and results are expected to be published in 2021.ConclusionsStudy findings will support planning for a future randomized controlled trial to assess the efficacy of OPC and service navigation support for caregivers of children awaiting ASD assessment.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12620000164998; www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378793&isReview=true.International registered report identifier (irrid)DERR1-10.2196/20011.
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Project description:BackgroundMany children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice.Methods and designThis paper describes the protocol for a randomized controlled trial (RCT) to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1) effective use of controller medications, 2) effective use of rescue medications and 3) monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1) the child's asthma control score, 2) the parent's quality of life score, and 3) the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications, having maintenance care visits at least twice a year, and an asthma action plan. Cost-effectiveness of the intervention was also measured.DiscussionTwenty-two practices (66 physicians) were randomized (11 per treatment group), and 950 families with a child 3-12 years old with persistent asthma were enrolled. A description of the coaching intervention is presented.
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Project description:BACKGROUND:Diabetes distress (DD), a type of psychological distress specific to people with diabetes, is strongly associated with difficulties in performing self-care and inability to meet glycemic targets. Despite increased recognition of the need to manage DD, interventions that are both feasible and effective for reducing DD in routine care settings are not yet known. A pilot study showed that health coaching (HC) has some efficacy in addressing DD, but no adequately powered study has implemented a pragmatic research design capable of assessing the real-world effectiveness of HC in reducing DD. OBJECTIVE:The aim of this study is to describe the rationale and design of an ongoing clinical trial, Coaching and Education for Diabetes Distress trial, that seeks to assess whether HC effectively reduces DD among primary care patients with diabetes and whether HC is more effective than an educational program targeting DD. METHODS:The 2-arm randomized controlled trial is taking place at an academic family medicine practice in Houston, Texas. Both arms will receive usual care, which includes education about DD. In addition, the intervention arm will receive 8 HC sessions over a 5-month period. The primary outcome measure is reduction in DD over a 6-month period. Additional outcome measures include changes in hemoglobin A1c and self-care practices (medication-taking, dietary, and physical activity behaviors). RESULTS:As of March 2019, screening and recruitment are ongoing, and the results are expected by July 2020. CONCLUSIONS:HC is feasible in primary care and has been successfully applied to improving chronic disease self-management and outcomes. This study will provide evidence as to whether it has significant value in addressing important unmet psychological and behavioral needs of patients with diabetes. TRIAL REGISTRATION:ClinicalTrials.gov NCT03617146; https://clinicaltrials.gov/ct2/show/NCT03617146 (Archived by WebCite at http://www.webcitation.org/76Va37dbO). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/12166.
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Project description:BackgroundRacial and ethnic minority adults with diabetes living in under-resourced communities face multiple barriers to sustaining self-management behaviors necessary to improve diabetes outcomes. Peer support and decision support tools each have been associated with improved diabetes outcomes.Methods290 primarily African American adults with poor glycemic control were recruited from the Detroit Veteran's Administration Hospital and randomized to Technology-Enhanced Coaching (TEC) or Peer Coaching alone. Participants in both arms were assigned a peer coach trained in autonomy-supportive approaches. Coaches are diabetes patients with prior poor glycemic control who now have good control. Participants met face-to-face initially with their coach to review diabetes education materials and develop an action plan. Educational materials in the TEC arm are delivered via a web-based, educational tool tailored with each participant's personalized health data (iDecide). Over six months, coaches call their assigned participants once a week to provide support for weekly action steps. Data are also collected on an Observational Control group with no contact with study staff. Changes in A1c, blood pressure, other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.Results290 participants were enrolled.DiscussionTailored e-Health tools with educational content may enhance the effectiveness of peer coaching programs to better prepare patients to set self-management goals, identify action plans, and discuss treatment options with their health care providers. The study will provide insights for scalable self-management support programs for diabetes and chronic illnesses that require high levels of sustained patient self-management.
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Project description:Occupational therapists may have an added value in the care of patients with Parkinson's disease whose daily functioning is compromised, as well as for their immediate caregivers. Evidence for this added value is inconclusive due to a lack of rigorous studies. The aim of this trial is to evaluate the (cost) effectiveness of occupational therapy in improving daily functioning of patients with Parkinson's disease.A multicenter, assessor-blinded, two-armed randomized controlled clinical trial will be conducted, with evaluations at three and six months. One hundred ninety-two home-dwelling patients with Parkinson's disease and with an occupational therapy indication will be assigned to the experimental group or to the control group (2:1). Patients and their caregivers in the experimental group will receive ten weeks of home-based occupational therapy according to recent Dutch guidelines. The intervention will be delivered by occupational therapists who have been specifically trained to treat patients according to these guidelines. Participants in the control group will not receive occupational therapy during the study period. The primary outcome for the patient is self-perceived daily functioning at three months, assessed with the Canadian Occupational Performance Measure. Secondary patient-related outcomes include: objective performance of daily activities, self-perceived satisfaction with performance in daily activities, participation, impact of fatigue, proactive coping skills, health-related quality of life, overall quality of life, health-related costs, and effectiveness at six months. All outcomes at the caregiver level will be secondary and will include self-perceived burden of care, objective burden of care, proactive coping skills, overall quality of life, and care-related costs. Effectiveness will be evaluated using a covariance analysis of the difference in outcome at three months. An economic evaluation from a societal perspective will be conducted, as well as a process evaluation.This is the first large-scale trial specifically evaluating occupational therapy in Parkinson's disease. It is expected to generate important new information about the possible added value of occupational therapy on daily functioning of patients with Parkinson's disease.Clinicaltrials.gov: NCT01336127.
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Project description:BACKGROUND:Chronic diseases, including diabetes mellitus, are the leading cause of mortality and disability in the United States. Current solutions focus primarily on diagnosis and pharmacological treatment, yet there is increasing evidence that patient-centered models of care are more successful in improving and addressing chronic disease outcomes. OBJECTIVE:The objective of this clinical trial is to evaluate the impact of a mobile health (mHealth) enabled nurse health coaching intervention on self-efficacy among adults with type-2 diabetes mellitus. METHODS:A randomized controlled trial was conducted at an academic health system in Northern California. A total of 300 participants with type-2 diabetes were scheduled to be enrolled through three primary care clinics. Participants were randomized to either usual care or intervention. All participants received training on use of the health system patient portal. Participants in the intervention arm received six scheduled health-coaching telephone calls with a registered nurse and were provided with an activity tracker and mobile application that integrated data into the electronic health record (EHR) to track their daily activity and health behavior decisions. All participants completed a baseline survey and follow-up surveys at 3 and 9 months. Primary and secondary outcomes include diabetes self-efficacy, hemoglobin A1c (HbA1c), and quality of life measures. RESULTS:Data collection for this trial, funded by the Patient-Centered Outcomes Research Institute, will be completed by December 2017. Results from the trial will be available mid-2018. CONCLUSIONS:This protocol details a patient-centered intervention using nurse health coaching, mHealth technologies, and integration of patient-generated data into the EHR. The aim of the intervention is to enhance self-efficacy and health outcomes by providing participants with a mechanism to track daily activity by offering coaching support to set reasonable and attainable health goals, and by creating a complete feedback loop by bringing patient-generated data into the EHR. TRIAL REGISTRATION:ClinicalTrials.gov NCT02672176; https://clinicaltrials.gov/ct2/show/NCT02672176 (Archived by WebCite at http://www.webcitation.org/6xEQXe1M5).
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Project description:Background. Physical inactivity is currently seen as one of the biggest global public health issue. Remote physical activity (PA) promotion programs are expected to be effective if they are individually tailored and include behavior change techniques, personal coaching, and regular prompting. However, it is still not fully understood which intervention components are most effective. This paper describes the rationale and design of a study on an individually tailored remote PA promotion program comparing the efficacy of coaching and prompting with a single written advice. Methods. In total, 288 adults (age 20 to 65 years) were randomly assigned to three different intervention arms of a 6-month-long PA promotion program. A minimal intervention group received a single written PA recommendation. The two remaining groups either received telephone coaching sessions (n = 12 calls) with or without additional short message service (SMS) prompting (n = 48 SMSs for each participant). Data assessment took place at baseline, at the end of the intervention, and after a six-month follow-up-period. The primary outcome of the study was self-reported PA. Objectively assessed PA, psychosocial determinants of PA, well-being, body mass index (BMI), and adherence were assessed as secondary outcomes. Conclusion. Findings of this three-arm study will provide insight into the short and long-term effects of coaching and prompting for PA promotion.
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Project description:BackgroundPreoperative anxiety in children causes negative postoperative outcomes. Parental presence at induction is a non-pharmacological strategy for relieving anxiety; nevertheless, it is not always possible or effective, namely when parents are overly anxious. Parental presence via video has been demonstrated to be useful in other contexts (divorce, criminal court). This study reports the feasibility of a randomized controlled trial to investigate the effect of video parental presence and parental coaching at induction on preoperative anxiety.MethodsThe study was a randomized, 2 × 2 factorial design trial examining parental presence (virtual vs. physical) and coaching (provided vs. not provided). Feasibility was assessed by enrollment rate, attrition rate, compliance, and staff satisfaction with virtual method with the NASA-Task Load Index (NASA-TLX) and System Usability Scale (SUS). For the children's anxiety and postoperative outcomes, the modified Yale Preoperative Anxiety Scale (mYPAS) and Post-Hospitalization Behavioral Questionnaire (PHBQ) were used. Parental anxiety was evaluated with the State-Trait Anxiety Inventory (STAI) questionnaire.ResultsA total of 41 parent/patient dyads were recruited. The enrollment rate was 32.2%, the attrition rate 25.5%. Compliance was 87.8% for parents and 85% for staff. The SUS was 67.5/100 and 63.5/100 and NASA-TLX was 29.2 (21.5-36.8) and 27.6 (8.2-3.7) for the anesthesiologists and induction nurses, respectively. No statistically significant difference was found in mYPAS, PHBQ and STAI.ConclusionA randomized controlled trial to explore virtual parental presence effect on preoperative anxiety is feasible. Further studies are needed to investigate its role and the role of parent coaching in reducing preoperative anxiety.
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