View clinical trials related to Feasibility Studies.
Filter by:The goal of this descriptive non-randomized feasibility study is to assess aspects of feasibility of the intervention arm in a planned full-scale randomized controlled trial testing the effectiveness of a self-management program for persons who have sustained a moderate to severe traumatic injury. All outcomes will be evaluated based on pre-defined success criteria. The main outcomes in the feasibility study are: - Consent rate of eligible patients - Drop-out rate - Attendance rate in the program sessions Secondary outcomes are the participants' acceptance, reception, and perceived usefulness. Other outcomes are fidelity and protocol adherence, as well as the feasibility of a telehealth version of the program and the data collection methods. The participants will receive a group-based self-management program consisting of eight weekly 2.5-hour sessions delivered by a multidisciplinary team. The self-management program is manualized and includes psychoeducation, training in self-management skills and strategies, setting goals, action planning, and sharing of experiences. The participants will also complete the pre- and post-intervention assessments.
This is a feasibility study to evaluate a decentralized (remote) clinical trial in Korea. In this study, an open-label, randomized, remote clinical trial to evaluate the effects of lactobacillus supplements on alleviating functional constipation symptoms in poor-health volunteers will be conducted.
This pilot study will assess the feasibility of a gratitude intervention to promote physical activity, and well-being and positively impact biomarkers of health among older African American breast cancer survivors. The intervention will also include a goal-setting component to promote exercise readiness and examine the cultural phenomena of the Superwoman schema among Black women.
Advance care planning (ACP) represents a process whereby a patient, in consultation with healthcare professionals, family members and important others, makes decisions about his or her future healthcare and wishes for end-of-life care and is widely advocated to improve end-of-life care for patients with heart failure (HF). Despite the growing emphasis on communication with HF patients and their relatives, there is no tradition in Denmark for systematical communication about wishes for end-of-life care. The aim of the study is to adapt the ACP to a new contest and target group and determine the feasibility and acceptable recruitment rate and completeness of potential outcome measures for a future RCT. A study of a complex intervention will be conducted to address all elements of an adapted ACP intervention in HF patients (NYHA class III, IV) and their relatives. Patients will be identified and recruited by HF specialist nurses or a cardiologist from the Department of Cardiology at North Zealand Hospital. The HF specialist nurses or the cardiologist will inform the patients about the study and obtain consent for the research staff to contact the patients by telephone. The patients will be further informed by the research staff and asked to fill out the baseline questionnaires. The patients will be asked to select the closest relatives who also will be offered participation. Included patients will receive an invitation with the date and time of their ACP meeting in their electronic patient record. They will be offered an ACP discussion which covers components e.g. symptom control, discussions on prognosis and illness limitations, and wishes for future and end-of-life care. Baseline and follow-up (4 and 12 weeks after the ACP meeting) will be made with disease-specific and generic questionnaires. Qualitative interview data will be obtained, and thematic analysis will uncover the patients, relatives and the clinician's perspectives and satisfaction with the intervention.
Exercise groups are a form of rehabilitation sport that is offered to cardiac patients (e.g. after a heart attack) in long-term rehabilitation. In Germany, the constant presence of a physician is mandatory. In order to meet the increasing demand for heart groups, the present study implements emergency care during the heart group sessions with three alternatives: paramedics, physician-on-call or specially trained instructors. In the present study the investigators compare these alternatives (three experimental conditions) with the conventional way (control condition). Perceived safety, trust, acceptance and organisational feasibility are the main outcomes of the study. The methods used are questionnaires to the participants, instructors, organizers and, if applicable, paramedics. Additionally, partially structured interviews with attending physicians are conducted according to an interview guide.
The feasibility study will investigate the potential of online recruitment for a randomized trial of the effectiveness of Mindhelper. Recruiting participants for intervention studies is increasingly difficult, as there are many commercials and research projects competing for people's attention. Thus, participation rates in research projects are generally declining. The widespread access to the internet, especially among adolescents, offers a new and attractive alternative strategy to recruit participants for intervention studies. The feasibility study will inform us whether it is possible to recruit young people with mental health problems who are not familiar with Mindhelper and then randomize them to use or not to use the website (block randomization). Furthermore, it is necessary to know whether it is possible to follow the two groups over time and assess relevant outcomes. We aim to answer the following questions: - Is it possible to identify and recruit young persons (15-25 years of age) in need of mental health promotion via social networking sites such as Facebook.dk? - How quickly is it possible to recruit people for the study through networking sites? - Is it possible to ensure that the intervention group uses the Mindhelper website (>75%) and minimize the likelihood that the control group uses it (<25%)? - Is it possible to follow the two groups to obtain information at first follow-up at one week (T2)? The results will inform the study design of the effectiveness study. If the feasibility study shows (i) that it is possible to recruit and randomize young people with mental health problems within a specified period, (ii) that both groups will follow their randomization into either the intervention or control group, and (iii) that it is possible to follow both groups to obtain follow-up data, then the main study will be conducted as an online recruited randomized effectiveness study (online RCT). If the feasibility study shows that the conditions are not ideal for achieving these goals, we will conduct a longitudinal panel study of Mindhelper users comparing different types of users.
The purpose of this pilot experiment is threefold. 1. To assess the efficacy of the recruitment strategy 2. To assess the acceptability and feasibility of the outcome measurement methods obtained in free-living in the participants homes 3. To assess the acceptability of the prescribed interventions to reduce screen media use
To assess recruitment rate, attrition, compliance with weekly exercise, smoking cessation, and quality of life with a multimodal prehabilitation protocol for women with breast cancer undergoing neo-adjuvant chemotherapy for breast cancer.