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Psychosocial Factors clinical trials

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NCT ID: NCT04683068 Completed - BRCA1 Mutation Clinical Trials

Promoting Men's Adherence to BRCA1/2 Germline Genetic Testing

BRCA-MEN
Start date: January 10, 2021
Phase: N/A
Study type: Interventional

BRCA1- and BRCA2-associated Hereditary Breast and Ovarian Cancer Syndrome (HBOC) increases the relative and absolute risk of developing breast and ovarian cancer and, to a lesser extent, prostate and pancreatic cancer. Men face BRCA-related cancer risks as women do, although with a different magnitude, and they may also transmit the mutations to their children. Notwithstanding, men have not received much attention since now. They are under-tested compared to women and the communication is not tailored on their needs. Research on the psychological determinants of men's informed decision-making is particularly lacking as well as experimental evidence on the efficacy of tailored messages on men's needs. Applying principles of the Health Action Process Approach (HAPA), the present protocol proposes a study with the aim to test psychological variables influencing men's decision-making. Moreover, the proposed research intends to test the efficacy of two messages through a randomized experimental study. A total of 264 participants will be involved, among the men's relatives of women with verified germline mutations. The study entails a pre- post- evaluation with randomization of the participants in two conditions corresponding to the two messages. The expected results provide answers related to the impact of action self-efficacy, outcome expectancy (personal or familiar), risk perception, health risk aversion, intolerance of uncertainty, perceived barriers, and coping self-efficacy on informed decision-making. Data gathered from this study may inform health care providers, policymakers, and public health managers about the communication strategy for men and about the psychological variables influencing decision-making.

NCT ID: NCT04526964 Completed - Self-management Clinical Trials

Improved Self-management for Patients on Ventricular Assist Device (VAD) Support - Phase 3

SELMA
Start date: September 7, 2020
Phase: N/A
Study type: Interventional

The number of patients suffering from end-stage heart disease challenges healthcare services in the western world, where an estimated 1-2% of the population suffer from this chronic condition. Ventricular assist device (VAD) implantations have become a common therapeutic strategy for those affected. Live with a VAD, however, is far from normal and does expose patients to multiple challenges and the need to adjust to a complex self-management. Inadequate self-management can lead to serious complications, specifically neuro-cognitive events, bleeding, and exit-site related wound infections may impair the outcome following the VAD implantation procedure. Based on systematized literature review and a previous prevalence assessment study (ClinicalTrials.gov Identifier: NCT04234230), a modular evidence-based curriculum has been developed by a multiprofessional group of experts. This curriculum aims at improving knowledge, skills, and competencies for those affected to empower VAD patients to better self-manage their everyday life with the VAD, and to regain quality of life. This study focuses on a multi-center implementation and evaluation of the curriculum using a fully powered randomized-controlled study (RCT) design. This RCT will be conducted at four established cardiac centers throughout Germany. Participants will be assigned to either intervention or control using a 1: 1 randomization scheme. Block-randomization will be performed by a professional from the study coordinating center not being involved into the clinical care for patients. At the participating sites, the group assignment is non-blinded to the professionals involved in order to enable the intervention so be carried out adequately. Participants in the control group (CGr) receive the standard follow-up procedures (care as usual). Participants in the intervention group (IGr) receive self-management support and skills training based on the modular self-management curriculum post-implant, and during regular outpatient follow-up. The intervention lasts for 3 months followed by a 9-month follow-up per participant. Based on the power calculations the inclusion of 142 patients is anticipated.

NCT ID: NCT02481544 Completed - Clinical trials for Myocardial Infarction

The Effects of Journaling on Health-Related Mood and Clinical Outcomes in Post-MI Patients

GRAT2015
Start date: April 2015
Phase: N/A
Study type: Interventional

Psychosocial factors, including positive affect, finding meaning in the event, and managing emotional distress, influence prognosis following a heart attack or myocardial infarction (MI). Gratitude, typically defined as a feeling or attitude in acknowledgment of a benefit that one has received or will receive, is associated with higher levels of well-being, and people who are more grateful experience less stress, are less depressed, have higher levels of control over their environment, and more positive ways of coping. The present project will examine the potential benefits of a gratitude intervention (i.e., 8 weeks of gratitude journaling) to increase positive health behaviors, psychological health, and physical functioning in post-MI patients as compared to journaling about memorable events as well as care as usual alone. The investigators will study psychological and physical functioning at baseline, following 8 weeks of gratitude journaling or care as usual, and at 4-month follow-up.

NCT ID: NCT01633918 Completed - Physical Activity Clinical Trials

FeetEnergy Approach to Increase Physical Activity and Reduce Screen Time in Adolescents

FeetEnergy
Start date: August 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to find out whether an Internet-supported FeetEnergy approach and two home works integrated in three health education lessons can increase adolescents' active commuting to school and leisure-time physical activity and decrease their screen time.

NCT ID: NCT00327431 Completed - Hypertension Clinical Trials

Relationship of Genes and Life Events to Blood Pressure

Start date: November 2006
Phase: N/A
Study type: Observational

Research suggests that blood pressure is influenced by both genetic and environmental factors. The goal of this study is to find genes that play a role in blood pressure and understand how they interact with life events (such as job stress) to influence blood pressure. We hypothesize that the gene for endothelin-1 is associated with increased blood pressure. Further, we predict that this genetic relationship is moderated by psychosocial stress factors, specifically job strain and marital cohesion.

NCT ID: NCT00212966 Completed - Clinical trials for Psychosocial Factors

Shared Mental Health Care Linking Mental Health Services With Family Medicine Groups

Start date: July 2004
Phase: N/A
Study type: Observational

The purpose of this study is to assess how a multidisciplinary team of mental health professionals provides services to patients from two family medicine practices.