Clinical Research Directory

The Impact of Continuous Case Support and Resource Provision in Clinical Social Work Interventions

Health-related social work fulfills an important function in accompanying and supporting individuals who are affected by health-related, social, and material problems. Despite many years of practical experience, however, there is still a lack of scientific evidence regarding its effectiveness, both in Switzerland and internationally. Reliable instruments for measuring the services provided by social work are lacking, as are representative studies. The ALIMEnt II study aims to further develop procedures for evidence-based impact measurement in the field of health-related social work and to contribute to closing this research gap: * By developing an instrument (measurement scale) to reliably assess the activities of social workers. * By applying this instrument to examine two central functions of health-related social work: providing support (accompaniment) and facilitating access to resources. The instrument captures which services are provided from the perspectives of both social workers and clients, as well as how clients' situations change over time from both their perspectives. This questionnaire will be used in a subsequent longitudinal study to examine the relationship between specific methods of professional practice and client outcomes. The results are intended to demonstrate the extent to which the instrument can be reliably used to capture the services of social work, and to provide evidence of the effectiveness of accompaniment and resource provision under different practice conditions. Investigating the assumed causal relationships under complex real-world practice conditions is challenging. To address this, the investigators use an impact model of health-related social work that was developed in a previous empirical study (ALIMEnt I). Both clients and social workers from the field of health-related social work will participate in the ALIMEnt II study.

Trial Without Borders IMPLEMENT-CKD: IMPLEMENTation of Evidence-Based SGLT2i to Reduce Global Burden of Cardiovascular and Chronic Kidney Disease

Chronic kidney disease (CKD) affects millions, especially in low- and middle-income countries, where many die early due to lack of treatment. One group of medicines, called SGLT2 inhibitors (SGLT2i), have been shown to slow down kidney damage and reduce the risk of heart-related deaths. The IMPLEMENT-CKD project will work with communities in Thailand, Fiji and Samoa to make it easier for people with CKD or type 2 diabetes to get these life-saving medicines as part of their regular care.

An Optimization Pilot to Optimize An Early Palliative Care Intervention for Advanced Heart Failure

Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this randomized factorial pilot trial is to identify feasibility, acceptability, and preliminary efficacy of components of an intervention (UPHOLDS) to improve quality of life of older adults with advancing heart failure. Using a 2x2x2x2 factorial design, 64 adults with advancing heart failure will be randomized to receive one or more palliative care coach-delivered components, based on Ferrans' Health-Related Quality of Life Model: 1) psychoeducation on palliative care principles (4 vs. 8 sessions); 2) financial coaching (yes vs. no); 3) one-time specialty outpatient palliative care consultation (yes vs. no); and monthly follow (1 monthly follow-up call vs. monthly follow-up calls for 24 weeks).

Project Talk Trial: Engaging Underserved Communities in End-of-life Conversations

Compared to the general population, individuals from underserved communities are more likely to receive low quality end-of-life care and unwanted, costly and burdensome treatments due in part to a lack of advance care planning (ACP; the process of discussing wishes for end-of-life care with loved ones/clinicians and documenting them in advance directives). This study will use existing, trusted, and respected social networks to evaluate two conversation-based tools intended to engage underserved individuals in discussions about end-of-life issue and motivate them to carry out ACP behaviors. Through this study, investigators will learn how best to engage underserved populations in ACP so as to: 1) increase the likelihood that patients from underserved communities will receive high-quality end-of-life care; 2) address health disparities related to end-of-life treatments; and 3) reduce unnecessary suffering for patients and their families.

Communitas: A Program for Teens Living With Chronic Illness and Their Families

The proposed pilot study is an evaluation of Communitas, a mind-body skills group visit and for 12-19 year-olds living with chronic physical illness. The goal of this study is to assess the efficacy and feasibility of these group visits. During 2017-2018, the investigators will recruit 50-100 patient and 50-100 parent enrollees of Communitas to participate in this study. The study will be a pre-post evaluation, without a control group, using validated patient-report assessments at baseline, after completion of the group visits, and 3 months later. The primary outcome variables will be physical and mental wellbeing, stress, mood, resilience, mindfulness, and social support. Paired t tests will be used to assess changes from baseline to immediately post-intervention \& 3 months post-intervention. The investigators will also calculate Cohen's d effect sizes, to help them understand the degree to which an effect is present in the population.

Addressing Pain Through Navigator-Led Palliative Care Optimized for Heart Failure (ADAPT-HF)

Using the MOST framework, factorial pilot design, and an iterative, community-based process, the purpose of this study is to pilot test to further develop and refine a palliative care (PC) intervention addressing pain of Black adults (age \> 18) with advanced HF. Thirty-six persons with advancing heart failure (HF) will be randomized to receive one of 16 conditions (different combinations of navigator coach-delivered PC pain intervention components).

PRISM Race and Communication Pilot RCT

This is a pilot randomized trial of 60 patients to test feasibility, acceptability and efficacy of PRISM to improve resilience and facilitate improved patient-clinician communication in racially minorities patients with serious illness.

Virtual ACT for Adolescent Stress

This study aims to test the effectiveness of a 6-week long virtual Acceptance Commitment group therapy as a non-pharmaceutical intervention to improving other functional outcomes for adolescents with a chronic medical condition in comparison to no treatment.

Effect of a Person-Centred Care Intervention for Families Providing Home-Based Care to a Person With Advanced Chronic Illness: A Pilot Randomised Controlled Trial

The goal of this clinical trial is to learn if a Person-Centred Care (PCC) intervention can improve the caregiving experience and wellbeing of families who provide home care for a loved one with advanced chronic illness. The main questions it aims to answer are: * Does the PCC intervention improve families' caregiving experience, preparedness for caregiving, and psychological wellbeing? * Is the PCC intervention feasible and acceptable for implementation in primary care settings? Researchers will compare families who receive the PCC intervention in addition to usual care to families who receive usual care alone. Participants will: * Take part in an initial in-person consultation with a primary care nurse to share their family caregiving experience and co-create a personalized health plan. * Have monthly follow-up contacts with the same nurse over a 3-month period to update and adapt the plan. * Receive a copy of the updated plan after each contact to guide caregiving and support decision-making.

Web-based Support for Family Caregivers of Patients With Advanced Cancer

For family caregivers of patients with advanced cancer, preparedness for caregiving is crucial for maintaining health and quality of life both during care and after the death of the patient. This project contributes to earlier research funded by the Swedish Cancer Society, about an intervention that was delivered by a multi-professional team and proved to be successful in promoting preparedness. However, such interventions are often costly and logistically challenging. In addition, the Covid-19 pandemic has further significantly raised the need for digital alternatives in healthcare. As a possible solution, an evidence-based intervention, narstaende.se, has been developed consisting of recorded videos of conversations between clinicians and family caregivers (actors), linked to informational texts and a moderated chat forum. The intervention was pilot tested during 2020 and 2021, exploring feasibility, content and family caregivers' experiences. As preliminary results are promising, the intervention is taken one step further and tested as a web-based intervention in a larger scale.