View clinical trials related to Feasibility.
Filter by:Given the limited effectiveness of single food group-targeted interventions to enhance child nutrition, a key component of current and future health, innovative approaches are needed. Healthy dietary patterns are emerging as an important intervention target, and the Mediterranean Dietary pattern has been particularly effective at reducing cardiovascular disease risk factors, a leading cause of death in the US. Since parents are the gatekeepers of the home food environment and influence child intake through food-related parenting practices, children enjoy cooking with parents, and home food preparation is associated with more healthful dietary intake. Therefore, the investigators propose to develop and assess the feasibility, acceptability, and preliminary efficacy of an online cooking intervention for parent-child dyads living in low-income households that promotes the Mediterranean dietary pattern and healthful food-related parenting practices.
Emotional disorders are among the most common childhood mental health difficulties. The majority of adult emotional disorders begin before age 14 years. Most children and families across the population do not receive the proven evidence-based interventions available, particularly those from socially disadvantaged neighbourhoods and excluded, Black and Minoritised populations. Families from disadvantaged neighbourhoods, Black and minoritised communities can often feel judged, mistrustful, and blamed for their children's behavioural difficulties making them reluctant to engage in parenting supportEven when available, research shows that over one-third of parents receiving traditional specialist delivered evidence-based parenting do not gain the expected outcomes. Undertaking a group-based parenting intervention to help parents understand and deal with their children's anxiety issues. The aim of this study is to examine the feasibility and acceptability of a new parent-led parenting intervention, being a Parent Helping your Child (BAPHYC) that is intended to improve childhood anxiety and to use the findings to inform the planning and conduct of a definitive randomised control trial. Being a Parent- Helping your Child (BAPHYC) has been developed from two well-established evidence-based parenting programmes. It is a parent-led, group format manualised parenting programme intended to improve childhood anxiety in children aged 5-12 years consisting of eight two-hourly weekly sessions peer-facilitated by two trained parent group leaders. The particants of BAPHYC participants are mothers, fathers and other carers who have principal parenting responsibility for a child with anxiety. The specific study objectives are to: 1. Establish initial evidence about reach and engagement, delivery, acceptability and impact of BAPHYC 2. Establish the feasibility of proposed recruitment pathways and measure completion 3. Acquire a fine grain understanding of parents' experiences of the BAPHYC intervention, research procedures and themes arising from BAPHYC implementation. 4. Assess participant recruitment, engagement, intervention and measure completion, and intervention acceptability rates against a priori feasibility parameters. 5. Obtain data that will be used in future trial recruitment and planning.
Brief Summary: Background: Feasibility and acceptability of the Carers-ID intervention to improve mental health outcomes in family carers of people with intellectual disabilities. Objective: 1. To conduct a Phase II feasibility randomised controlled trial and process evaluation of the Carers-ID programme. 2. To determine the acceptability of outcome measures of stress, anxiety, depression, resilience and well-being in assessing the impact of the programme on family carers. 3. To determine the recruitment and retention rates of participants in the trial. 4. To identify potential effect sizes and estimate appropriate sample size for use in an effectiveness trial. 5. To determine if progression to a phase III effectiveness trial is warranted. Methodology: Family carers (n = 120) will be randomised to receive the programme (n=60) or assigned to a wait-list control (n=60) group. The intervention (Carers-ID) consists of ten modules which cover topics including: promoting resilience, reducing anxiety, managing stress, accessing local supports, managing family conflict and information for siblings who are carers. Participants (n=12) who have taken part in the intervention arm of the research will be invited to participate in the process evaluation. Outcome: 1. Retention of Subjects in Study Assessments (>80% of family carers) 2. Recruitment of Subjects into Study (>90 carers) 3. Acceptability and feasibility of the outcome measures (>80% of family carers) 4. Depression, Anxiety and Stress Scale - 21; The Warwick-Edinburgh Mental Well-being Scale; The Resilience Scale; and The Social Connectedness Scale Revised. Number of participants to be enrolled: 120 family carers Main inclusion criteria: Participants will be UK adults >18 years of age and will be caring for a family member with an intellectual disability. Statistical Analysis: Descriptive statistics will be used to summarise baseline data including demographic variables and questionnaire responses. Inferential statistics (t-tests or ANOVA) will be used as indicators of difference between the intervention and control arms and will be used to determine effect sizes for sample size calculation in a future phase III trial. Study duration: 24 months
According to the World Health Organization, more than 50 million people have epilepsy. Among them, nearly 80% of epileptic patients live in developing countries and 75% of them do not have access to treatment. The ketogenic diet (KD) has been shown as an effective alternative for patients with drug-resistant epilepsy. Although it has been studied by few studies in Asia, no such studies have been conducted in Vietnam. The purpose of this study was to verify the feasibility, tolerability, and efficacy of the KD in children with refractory epilepsies followed at a pediatric center in South Vietnam.
For patients with irresectable locally advanced non-small cell lung cancer (NSCLC) (e.g. multilevel or bulky N2 disease or presence of N3 lymph node metastases), current guidelines recommend treatment with chemoradiotherapy (CRT) followed by immune checkpoint inhibition (ICI, durvalumab). Chances of sterilization of a large (e.g. clinically staged T3 or T4 tumor) tumor volume by CRT alone are relatively small and these tumors are associated with a high local recurrence rate. Moreover, necrosis and cavitation of these tumors puts these patients at risk of fatal bleeding and might cause infectious complications, which lead to subsequent impaired quality of life (QoL) and to interruption of, or the need for postponing, (systemic) treatment. Upfront resection of the tumor in the lung, followed by postoperative CRT in patients who have a (potentially) resectable tumor could be a strategy to prevent complications of CRT in large volume and/or cavitating tumors with extensive mediastinal disease.
Introduction: In patients treated for cardiac disease, loneliness is known to contribute negatively to health behavior, health outcome and increase risk of cardiac and all-cause mortality. Even so, in health care research, social support interventional studies targeting patients who experience loneliness is lacking. Aim: To determine the feasibility of an individually structured social support intervention targeting patients treated for cardiac disease who experience loneliness. Design: A feasibility study based on randomized clinical trial design with 1:1 randomization to a 6-month social support program, plus usual care (intervention) versus usual care, (i.e., regular guidelines-based follow-up). Intervention: Patients classified as high risk lonely according to the High Risk Loneliness tool will be provided with an informal caregiver in the six months rehabilitation phase following cardiac disease treatment. The informal caregiver will be designated by the patient from the existing social network or a peer, depending on patients' preferences. The core content of the intervention is through nurse consultations at baseline, one, three and six months, to enhance and reinforce the informal caregiver's competences to be a social support resource. The theoretical framework of the nurse consolations will be based on Middle-range theory of self-care. Outcome: Feasibility will be evaluated in terms of acceptability and adherence according to predefined feasibility criteria. The preliminary effect of the intervention on patient-reported outcomes, health behaviors and health outcomes will be evaluated in the intervention and the control group at baseline, one, three, six and twelve months.
The study has a randomized crossover design including qualitative interviews of the participant's test experiences. Healthy participants, ≥60 years are eligible to participate in the study. Cognitive function will be measured by using the International Study Group of Postoperative Cognitive Dysfunction (ISPOCD) test battery and the Mindmore digital test battery. The participants will self-report their likelihood of depression with the geriatric depression scale-15, their user experience of the digital test by a modified version of System Usability scale, and answer questionnaires targeting their experiences of the test sessions. Furthermore, concentration difficulties, according to the Swedish Quality of Recovery-scale will also be measured.
Background: Feasibility and acceptability of bubble continuous positive airway pressure (CPAP) were not evaluated in childhood severe pneumonia in developing countries at a larger scale. Objective: 1. To describe prevailing structural and functional conditions and other operational challenges in nontertiary hospitals in Bangladesh that would need to be addressed in order to introduce bubble CPAP as part of the management of children with severe pneumonia enabling a successful interventional trial. 2. To develop and test bubble CPAP training materials of relevance to clinical staff providing care for children with severe pneumonia in district general hospitals. 3. To determine the prevalence of hypoxaemia among hospitalised children with severe pneumonia in non-tertiary/district hospitals, current practices with regard to management and clinical outcome, to support power calculations of a future interventional trial of bubble CPAP for children with severe pneumonia. 4. To document the early experience, particularly the feasibility and acceptability of introducing bubble CPAP in selected non-tertiary/district hospitals. Methodology: Feasibility/demonstration phase will be done as an internal pilot in 2 hospitals. Current treatment practice, facilities, and operational challenges will be evaluated for the introduction, clinical use and maintenance of bubble CPAP. Outcome: 1. To describe the structural and functional conditions and operational challenges that may influence the introduction of bubble CPAP. 2. To have bubble CPAP training materials that can be delivered cheaply and repeatedly to a level of comprehension of staff providing care to children with pneumonia in district general hospitals in Bangladesh. 3. A quantitative analysis of the incidence of hypoxaemia among hospitalised children with severe pneumonia, current management practices and clinical outcomes. 4. A qualitative assessment of the feasibility of introducing bubble CPAP. Number of children to be enrolled: 20 children in 2 hospitals as an internal pilot (i.e. 10 in each hospital) Main inclusion criteria: Age between 2 months and 24 months with severe pneumonia and hypoxemia and guardian/parent gives written informed consent to participate in the study. Statistical Analysis: For feasibility and acceptability study, a descriptive analysis will be performed. Study duration: 44 months
This is a prospective registration study for patients with advanced refractory solid tumors. Patients who meet the eligibility criteria will be included to participate in the study, and baseline information to be collected after signed informed consent. Patients will choose for themselves whether to carry out targeted therapy or other appropriate treatment methods. And we plan to follow up for at least 12 months or until disease progression or death.
An open-label, multi-centre, 26-weeks clinical feasibility study. The objective is to explore whether Saxenda could be a feasible choice in the treatment of overweight, obesity and weight-related medical problems, in patients diagnosed with a severe mental illness and hospitalized at a forensic department in Denmark. We wish to determine the viability of the daily Saxenda®-injection treatment in this specific patient group.