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A virtual clinic for the management of diabetes-type 1: study protocol for a randomised wait-list controlled clinical trial.

ABSTRACT: BACKGROUND:Diabetes is a serious chronic disease. Medical treatment and good psychosocial support are needed to cope with acute and long-term effects of diabetes. Self-management is a large part of diabetes management, with healthcare providers playing a supportive role. Young adults with type 1 diabetes are of special interest as they tend to have higher mean glycosylated haemoglobin values than other patients with type 1 diabetes, and they often miss visits in traditional diabetes care. A well-designed virtual solution may improve a range of measures (e.g. glycaemic control and perceived health) and reduce hospitalisations. METHOD:This randomised controlled trial with a control group using a wait list design will recruit 100 young adults from a hospital in Sweden. All participants will receive usual diabetes care besides the virtual clinic. The primary objective is to evaluate the effect of a virtual diabetes clinic on glycaemic control, treatment satisfaction and quality of life in young adults (aged 18-25?years) with type-1 diabetes. The secondary objective is to determine the effects of virtual care on the patient experience. DISCUSSION:Virtual tools are becoming increasingly common in healthcare; however, it remains unclear if these tools improve diabetes self-management. The results of this study will build understanding of how healthcare providers can use a virtual clinic to improve diabetes self-management. TRIAL REGISTRATION:Current controlled trials: ISRCTN, number: 73435627, registered 23 October 2019. https://doi.org/10.1186/ISRCTN73435627.

SUBMITTER: Nerpin E

PROVIDER: S-EPMC7487575 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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A virtual clinic for the management of diabetes-type 1: study protocol for a randomised wait-list controlled clinical trial.

Nerpin Elisabet E Toft Eva E Fischier Johan J Lindholm-Olinder Anna A Leksell Janeth J

BMC endocrine disorders 20200905 1

<h4>Background</h4>Diabetes is a serious chronic disease. Medical treatment and good psychosocial support are needed to cope with acute and long-term effects of diabetes. Self-management is a large part of diabetes management, with healthcare providers playing a supportive role. Young adults with type 1 diabetes are of special interest as they tend to have higher mean glycosylated haemoglobin values than other patients with type 1 diabetes, and they often miss visits in traditional diabetes care ...[more]

PMID: 32891126

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Project description:BACKGROUND:Management of diabetes through improved glycemic control and risk factor modification can help prevent long-term complications. Much diabetes management is self-management, in which healthcare providers play a supporting role. Well-designed e-Health solutions targeting behavior change can improve a range of measures, including glycemic control, perceived health, and a reduction in hospitalizations. METHODS:The primary objective of this study is to evaluate if a mobile application designed to improve self-management among patients with type 2 diabetes (T2DM) improves glycemic control compared to usual care. The secondary objectives are to determine the effects on patient experience and health system costs; evaluate how and why the intervention worked as observed; and gain insight into considerations for system-wide scale-up. This pragmatic, randomized, wait-list-control trial will recruit adult participants from three Diabetes Education Programs in Ontario, Canada. The primary outcome is glycemic control (measured by HbA1c). Secondary outcomes include patient-reported outcomes and patient-reported experience measures, health system utilization, and intervention usability. The primary outcome will be analyzed using an ANCOVA, with continuous secondary outcomes analyzed using Poisson regression. Direct observations will be conducted of the implementation and application-specific training sessions provided to each site. Semi-structured interviews will be conducted with participants, healthcare providers, organizational leaders, and system stakeholders as part of the embedded process evaluation. Thematic analysis will be applied to the qualitative data in order to describe the relationships between (a) key contextual factors, (b) the mechanisms by which they effect the implementation of the intervention, and (c) the impact on the outcomes of the intervention, according to the principles of Realist Evaluation. DISCUSSION:The use of mobile health and virtual tools is on the rise in health care, but the evidence of their effectiveness is mixed and their evaluation is often lacking key contextual data. Results from this study will provide much needed information about the clinical and cost-effectiveness of a mobile application to improve diabetes self-management. The process evaluation will provide valuable insight into the contextual factors that influence the application effectiveness, which will inform the potential for adoption and scale. TRIAL REGISTRATION:Clinicaltrials.gov NCT02813343 . Registered on 24 June 2016 (retrospectively registered). Trial Sponsor: Ontario Telemedicine Network.

Project description:IntroductionIntegrating diabetes self-management into daily life involves a range of complex challenges for affected individuals. Environmental, social, behavioural and emotional psychological factors influence the lives of those with diabetes. The aim of this study is to evaluate the impact of a stress management group intervention based on acceptance and commitment therapy (ACT) among adults living with poorly controlled type 1 diabetes.Methods and analysisThis study will use a randomised controlled trial design evaluating treatment as usual (TAU) and ACT versus TAU. The stress management group intervention will be based on ACT and comprises a programme divided into seven 2-hour sessions conducted over 14 weeks. A total of 70 patients who meet inclusion criteria will be recruited over a 2-year period with follow-up after 1, 2 and 5 years.The primary outcome measure will be HbA1c. The secondary outcome measures will be the Depression Anxiety Stress Scales, the Swedish version of the Hypoglycemia Fear Survey, the Swedish version of the Problem Areas in Diabetes Scale, The Summary of Self-Care Activities, Acceptance Action Diabetes Questionnaire, Swedish Acceptance and Action Questionnaire and the Manchester Short Assessment of Quality of Life. The questionnaires will be administered via the internet at baseline, after sessions 4 (study week 7) and 7 (study week 14), and 6, 12 and 24 months later, then finally after 5 years. HbA1c will be measured at the same time points.Assessment of intervention effect will be performed through the analysis of covariance. An intention-to-treat approach will be used. Mixed-model repeated measures will be applied to explore effect of intervention across all time points.Ethics and disseminationThe study has received ethical approval (Dnr: 2016/14-31/1). The study findings will be disseminated through peer-reviewed publications, conferences and reports to key stakeholders.Trial registration numberNCT02914496; Pre-results.

Project description:IntroductionNumerous studies support the practice of different physical exercise modalities as an effective treatment to address the problems associated with schizophrenia, reporting that they result in improvements in patient symptoms and quality of life. Given the lack of studies comparing different types of training in controlled environments, the aim of this proposed study will be to compare the effects of three physical exercise programmes (strength, aerobic and mixed) on the symptoms, body composition, level of physical activity and health-related quality of life of patients with schizophrenia.Methods and analysisA multicentre, single-blinded (evaluator), randomised, wait-list controlled (ratio 2:2:2:1) trial will be conducted with 105 patients recruited from different psychosocial care centres. The participants will be randomised into three 16-week training groups comprising 48 sessions lasting 1 hour each, or to the wait-list control group. The training groups will complete aerobic, strength or mixed (aerobic+strength) training. The participants will be assessed before, immediately after and 6 months after the end of the intervention. The patients in the wait-list control group (n=15) will receive one of the three trainings immediately after the intervention. The study variables will include positive, negative and general symptomology (Positive and Negative Syndrome Scale) as the primary outcome; as secondary outcome: body composition (by assessing body mass index, body fat mass and waist circumference), physical activity levels (International Physical Activity Questionnaire-Short Form) and quality of life (abbreviated WHO Quality of Life questionnaire).Ethics and disseminationThis study was approved by the ethics committees for Biomedical Research at the CEU Cardenal Herrera University of Valencia, Spain (CEI18/215). Participants will be fully informed of the purpose and procedures of the study, and written informed consent will be obtained. The results from this study will be published in peer-reviewed journals and presented in scientific conferences.Trial registration numberNCT04987151.

Project description:BackgroundCommon mental disorders such as depression and anxiety are major contributors to the global burden of disease. Affected individuals suffer reduced quality of life, impaired functioning and reduced capacity to work. Maintaining employment is an important determinant for health and wellbeing, and the economic impact of depression and anxiety is a significant societal expense. Treatments providing effective symptom reduction and helping patients return to work (RTW) would thus have substantial public health benefits. The present study will explore the effectiveness of metacognitive therapy (MCT) and work-focused interventions on reducing symptoms and increasing RTW rates for patients on sick leave due to depression and anxiety.MethodsThe study is a randomised controlled wait-list trial (RCT; N = 240). The intervention group will receive protocol-based MCT and work-focused interventions immediately after inclusion. The control condition is a wait-list control group. All patients will receive up to 12 weekly sessions. The study context is a Norwegian outpatient clinic part of a national programme aimed at reducing sick leave. The co-primary outcomes are change in RTW and symptoms of depression and anxiety at the end of treatment. In addition to self-report, sick leave will also be collected from national registries from 2 years prior to intervention to 4 years after intervention. Symptoms of scores will be collected by self-report at pre- and post-treatment and at 6 and 12 months follow-up after treatment. A cost-effectiveness analysis will use total cost and quality-adjusted life-years as the secondary outcomes.DiscussionThere is broad consensus on the importance of identifying treatment that effectively reduces depression and anxiety symptoms and aids RTW. This study is an important contribution to the field as it is the first RCT on MCT and work-focused interventions for patients on sick leave due to anxiety and depression.Trial registrationClinicalTrials.gov NCT03301922 . Registered on October 4, 2017.

Project description:Being diagnosed with cancer causes major psychological distress, yet the majority of newly diagnosed cancer patients lack psychological support. Internet interventions overcome many barriers for seeking face-to-face support and allow for independence in time and place. We assess efficacy and feasibility of the first web-based stress management intervention (STREAM: STREss-Aktiv-Mindern) for newly diagnosed, German-speaking cancer patients.In a prospective, wait-list controlled trial 120 newly diagnosed cancer patients will be included within 12 weeks of starting anti-cancer treatment and randomized between an immediate (intervention group) or delayed (control group) 8-week, web-based intervention. The intervention consists of eight modules with weekly written feedback by a psychologist ("minimal-contact") based on well-established stress management manuals including downloadable audio-files and exercises. The aim of this study is to evaluate efficacy in terms of improvement in quality of life (FACT-F), as well as decrease in anxiety and depression (HADS), as compared to patients in the wait-list control group. A sample size of 120 patients allows demonstrating a clinically relevant difference of nine points in the FACT score after the intervention (T2) with a two-sided alpha of 0.05 and 80 % power. As this is the first online stress management intervention for German-speaking cancer patients, more descriptive outcomes are equally important to further refine the group of patients with the largest potential for benefit who then will be targeted more specifically in future trials. These descriptive endpoints include: patients' characteristics (type of cancer, type of treatment, socio-demographic factors), dropout rate and dropout reasons, adherence and satisfaction with the program.New technologies open new opportunities: minimal-contact psychological interventions are becoming standard of care in several psychological disorders, where their efficacy is often comparable to face-to-face interventions. With our study we open this field to the population of newly diagnosed cancer patients. We will not only assess clinical efficacy but also further refine the target population who has the most potential to benefit. An internet-based minimal-contact stress management program might be an attractive, time- and cost-effective way to effectively deliver psychological support to newly diagnosed cancer patients and an opportunity to include those who currently are not reached by conventional support.ClinicalTrials.gov NCT02289014 .

Project description:Purpose Being diagnosed with cancer causes major psychological distress; however, a majority of patients lack psychological support during this critical period. Internet interventions help patients overcome many barriers to seeking face-to-face support and may thus close this gap. We assessed feasibility and efficacy of Web-based stress management (STREAM [Stress-Aktiv-Mindern]) for newly diagnosed patients with cancer. Patients and Methods In a randomized controlled trial, patients with cancer who had started first-line treatment within the previous 12 weeks were randomly assigned to a therapist-guided Web-based intervention or a wait-list (control), stratified according to distress level (≥ 5 v < 5 on scale of 0 to 10). Primary efficacy end point was quality of life after the intervention (Functional Assessment of Chronic Illness Therapy-Fatigue). Secondary end points included distress (Distress Thermometer) and anxiety or depression (Hospital Anxiety and Depression Scale). Treatment effect was assessed with analyses of covariance, adjusted for baseline distress. Results A total of 222 of 229 screened patients applied online for participation. Between September 2014 and November 2016, 129 newly diagnosed patients with cancer, including 92 women treated for breast cancer, were randomly assigned to the intervention (n = 65) or control (n = 64) group. Adherence was good, with 80.0% of patients using ≥ six of eight modules. Psychologists spent 13.3 minutes per week (interquartile range, 9.5-17.9 minutes per week) per patient for online guidance. After the intervention, quality of life was significantly higher (Functional Assessment of Chronic Illness Therapy-Fatigue: mean, 8.59 points; 95% CI, 2.45 to 14.73 points; P = .007) and distress significantly lower (Distress Thermometer: mean, -0.85; 95% CI, -1.60 to -0.10; P = .03) in the intervention group as compared with the control. Changes in anxiety or depression were not significant in the intention-to-treat population (Hospital Anxiety and Depression Scale: mean, -1.28; 95% CI, -3.02 to 0.45; P = .15). Quality of life increased in the control group with the delayed intervention. Conclusion The Web-based stress management program STREAM is feasible and effective in improving quality of life.

Project description:BackgroundCaregiving can be stressful, potentially creating physical and psychological strain. Substantial evidence has shown that family caregivers suffer from significant health problems arising from the demands of caregiving. Although there are programs supporting caregivers, there is little evidence regarding their effectiveness. Acupressure is an ancient Chinese healing method designed to restore the flow of Qi (vital energy) by applying external pressure to acupoints. A randomized, wait-list controlled trial was developed to evaluate the effectiveness of a self-administered acupressure intervention on caregiver stress (primary objective) and stress-related symptoms of fatigue, insomnia, depression, and health-related quality of life (secondary objectives) in Chinese caregivers of older family members.MethodsTwo hundred Chinese participants, aged ≥ 21 years, who are the primary caregivers of an older family member and screen positive for caregiver stress and symptoms of fatigue/insomnia/depression will be recruited from a community setting in Hong Kong. Subjects will be randomized to receive either an immediate treatment condition (self-administered acupressure intervention) or a wait-list control condition. The self-administered acupressure intervention will include (i) an individual learning and practice session twice a week for 2 weeks, (ii) a home follow-up visit once a week for 2 weeks, and (iii) 15-min self-practice twice a day for 6 weeks. The wait-list control group will receive the same acupressure training after the intervention group has completed the intervention. We hypothesize that Chinese family caregivers in the intervention group will have lower levels of caregiver stress, fatigue, insomnia, depression, and higher health-related quality of life after completion of the intervention than participants in the wait-list control group.DiscussionThis study will provide evidence for the effectiveness of self-administered acupressure in reducing stress and improving symptoms of fatigue, insomnia, depression, and health-related quality of life in Chinese family caregivers. The findings will inform the design of interventions to relieve negative health effects of caregiving. Furthermore, the results can raise community awareness and serve as a basis for policymaking, planning, and allocation of resources regarding empowerment of family caregivers for self-care.Trial registrationCurrent Controlled Trials NCT02526446 . Registered August 10, 2015.

Project description:BackgroundUnderstanding how frailty affects patients listed for transplantation has been identified as a priority research need. Frailty may be associated with a high risk of death or wait-list withdrawal, but this has not been evaluated in a large multicenter cohort of Canadian wait-listed patients.ObjectiveThe primary objective is to evaluate whether frailty is associated with death or permanent withdrawal from the transplant wait list. Secondary objectives include assessing whether frailty is associated with hospitalization, quality of life, and the probability of being accepted to the wait list.DesignProspective cohort study.SettingSeven sites with established renal transplant programs that evaluate patients for the kidney transplant wait list.PatientsIndividuals who are being considered for the kidney transplant wait list.MeasurementsWe will assess frailty using the Fried Phenotype, a frailty index, the Short Physical Performance Battery, and the Clinical Frailty Scale at the time of listing for transplantation. We will also assess frailty at the time of referral to the wait list and annually after listing in a subgroup of patients.MethodsThe primary outcome of the composite of time to death or permanent wait-list withdrawal will be compared between patients who are frail and those who are not frail and will account for the competing risks of deceased and live donor transplantation. Secondary outcomes will include number of hospitalizations and length of stay, and in a subset, changes in frailty severity over time, change in quality of life, and the probability of being listed. Recruitment of 1165 patients will provide >80% power to identify a relative hazard of ≥1.7 comparing patients who are frail to those who are not frail for the primary outcome (2-sided α = .05), whereas a more conservative recruitment target of 624 patients will provide >80% power to identify a relative hazard of ≥2.0.ResultsThrough December 2019, 665 assessments of frailty (inclusive of those for the primary outcome and all secondary outcomes including repeated measures) have been completed.LimitationsThere may be variation across sites in the processes of referral and listing for transplantation that will require consideration in the analysis and results.ConclusionsThis study will provide a detailed understanding of the association between frailty and outcomes for wait-listed patients. Understanding this association is necessary before routinely measuring frailty as part of the wait-list eligibility assessment and prior to ascertaining the need for interventions that may modify frailty.Trial registrationNot applicable as this is a protocol for a prospective observational study.

Dataset Information

A virtual clinic for the management of diabetes-type 1: study protocol for a randomised wait-list controlled clinical trial.

Publications

A virtual clinic for the management of diabetes-type 1: study protocol for a randomised wait-list controlled clinical trial.

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