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407 active trials for Quality of Life

Safe and Well Visits by the Fire and Rescue Service to Prevent Falls and Improve Quality of Life in Older People

FIREFLI is a large, pragmatic, individually randomised, controlled trial with embedded economic and qualitative evaluations. The aim of the research is to see whether Safe and Well Visits delivered by the Fire and Rescue Service will lead to a reduction in the number of falls and an improvement in health-related quality of life in older people. It will also look at the cost-effectiveness of the intervention and explore the acceptability of the Safe and Well Visits to older people and the Fire and Rescue Service. The investigators will recruit 1156 participants, randomly divided into two equal groups. One group (the intervention group) will receive the Safe and Well Visit at the beginning of the study and the other group (the control group) will receive the visit at the end of the study. The investigators will collect the number of falls people have using monthly falls calendars and follow up other outcomes by questionnaires at four, eight and 12 months post-randomisation. The investigators will also undertake interviews with some participants and with Fire and Rescue Service staff to explore experiences around the Safe and Well Visits. Two Studies within a Trial (SWAT) will be carried out to investigate more efficient ways of running trials. The first will test if using a recruitment invitation letter informed by Self-Determination Theory will increase the number of participants who take part in the study. The second will test if including a pen with the reminder four-month questionnaire will increase the number of postal questionnaires returned to the study team.

Start: May 2021
Physical Rehabilitation in Sickle Cell Anemia

Sickle cell anemia (SCA) is one of the most neglected diseases worldwide, according to the World Health Organization. In the adult population with SCA, the systemic effects of the disease, such as respiratory and peripheral muscle dysfunction, cause a decrease in quality of life. As a consequence, there is a concern about functional rehabilitation, since the aging of this population is already a reality in our environment. Thus, the objective of this project is to evaluate the effects of functional rehabilitation on quality of life in adult patients over 18 years of SCA. In this longitudinal intervention study, patients will be submitted to a three-month rehabilitation program. Before and after the intervention, patients will be submitted to the following assessments: spirometry; quality of life questionnaire - Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36); functional scale of joint integrity - Lower Extremity Functional Scale (LEFS); fatigue assessment scale - Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F); physical activity assessment questionnaire - International Physical Activity Questionaire (IPAQ); peripheral muscle assessment (handgrip and isometric dynamometry of the quadriceps muscle); and 6-minute walk test (6MWT). The protocol will consist of warm-up and cool-down exercises, muscle strengthening and endurance exercises, aerobic training, balance training and proprioception. Thus, it is expected that patients with sickle cell anemia will benefit significantly, with a consequent improvement in musculoskeletal function, pain and health-related quality of life.

Start: January 2020
Efficacy of Expressive Writing on Quality of Life Among Breast Cancer Survivors in Oman: A Double Blind Randomized Controlled Trial

Background Breast cancer is the most common cancer affecting women globally. Additionally, it is the most common cause of cancer mortality among women. Internationally, breast cancer is the most frequently diagnosed cancer among women in 140 of 184 countries. Global registry surveys also demonstrate that the incidence of breast cancer will increase by 46% and affect more than 3,059,829 people by 2040. The rate of breast cancer deaths will increase by 58.3% and affect more than 356,225 women. Psychologically, it has been shown that emotional suppression experienced by some women with breast cancer is highly predictive of low quality of life and psycho-somatic morbidities during the process of treatment. Such attitude towards emotional suppression is thriving well in Arab societies where somatizing, as opposed to psychologizing, distress is prevailing proclivity. Expressive writing may provide a tool to meet such need. Taken together and given the lack of any study exploring EW effect of Quality of life in women with breast cancer. The current study aims to examine the impact of expressive writing on quality of life in a randomized controlled trial among cancer survivor in Oman. Hypothesis The primary hypothesis states that compared to writing about neutral topic, expressive writing intervention will lead to a better improvement in quality of life among breast cancer patients after two months of the intervention. Objectives To assess the efficacy of 3 sessions EWI versus Writing about neutral topic, on Quality of life of Breast Cancer Survivors at 1- and 2-month post intervention. Method This study is a multicenter, prospective, double blind, parallel RCT with a 2-month follow-up and will be carried out at Oman's comprehensive cancer care & research center and Sultan Qaboos University Hospital, Muscat, Oman. Sixty four participants will be randomized to 3 sessions EWI group or neutral topic writing group, using a fixed randomization schedule allocating participant between the two intervention arms in a 1:1 ratio.

Start: January 2022
ACP in Older Patients With Multimorbidity: a Randomized Pilot

Rationale A recent study into the patient perspective of patients with multiple chronic conditions in the Netherlands underlines the strain multimorbidity can put on people. Most patients would appreciate more coordination from and communication with their care providers. This call for better coordination of needs and preferences ties into the concept of Advance Care Planning (ACP). ACP is a structured process of communication in which patients and physicians discuss and, if applicable, document health preferences and goals of patients regarding their last phase in life. Most ACP studies have been performed amongst older, terminally ill patients with the main aim of establishing patients' preferences before they lose capacity. We want to investigate the potential of ACP to increase patient empowerment in a population of competent patients with multimorbidity, who are not necessarily in their last phase of life. The distribution of healthcare expenditure among the population requiring care is skewed. In the Netherlands the top-10% most cost incurring patients account for 68% of expenditure. Many of these patients receive unnecessary or ineffective care, with a recent study estimating preventable spending at 10%. High-Need High-Cost patients comprise a very heterogeneous group, yet one common denominator explaining high cost is the high prevalence of multiple chronic conditions. Both overtreatment and conflicting treatment are legitimate concerns within this population. As multimorbidity and frailty increase with age, the older patient with multimorbidity is especially at risk. Targeted care programmes have been developed under the assumption that better coordination will lead to a reduction in healthcare utilization. However, although care might be identified as preventable or inefficient from a medical point of view, this is not necessarily the case from a patient perspective. We are interested how patients experience such care and thereby if better coordination would indeed lead to a reduction in utilization. Because ACP supports patients in timely recognition and better expression of their needs and preferences, we hypothesize that care will address those needs and preferences more adequately, which will result in improved patient assessment of care. We further hypothesize that patient empowerment will enable better planning of care and decision making, which can result in less unwanted or preventable interventions. As a consequence healthcare utilization might decrease. However, another possibility is that rather than leading to a decrease, improved empowerment may lead to an increase in utilization because care which is deemed superfluous from a medical perspective might not be perceived as such by patients. Objective The primary objective of our pilot study is to assess the feasibility of a formal Randomized Controlled Trial. Our secondary pilot objectives are to collect data on patient experience of healthcare, patient engagement, cost-effectiveness, and other data that might inform the design of a full-scale RCT. Study design Randomized pilot study Study population Patients over 65 years of age with polypharmacy, multimorbidity and multiple hospitalizations and/or ER admissions in the past year Intervention One of the most well-researched ACP programmes is the Respecting Choices Programme. In this programme, a trained facilitator encourages patients to reflect on their goals, values and beliefs, to discuss and document their future choices, and to appoint a surrogate decision maker. The programme was translated to the Dutch context in previous studies in the nursing home setting and oncology care. Patients randomized to receive ACP will have two meetings with a trained facilitator within two months. Main study parameters/endpoints Primary: trial-feasibility is defined as the successful inclusion of 50 patients in total, timely administration of the intervention in 25 patients, adherence to follow-up procedures and identification of problems or barriers during recruitment, inclusion, intervention administration and follow-up. Secondary: main outcome for cost-effectiveness is total duration and number of hospital admissions, as a proxy for both costs and effects (iMCQ). In order to inform a future cost-effectiveness analysis (CEA), data on health-related quality of life (EQ5D-5L) will also be collected. Our outcomes for patient assessment of care and patient empowerment are the PACIC questionnaire, the ACP Engagement Survey and the appointment of a surrogate decision maker and/or the documentation of advance directives.

Start: May 2021
Expanding Knowledge About and Evaluating Services for Incarcerated Pregnant and Postpartum Women in Arkansas

Incarcerated pregnant women are a largely invisible special population with great need for health care and advocacy. The number of women who are incarcerated in the U.S. has increased over 750%, or from 13,258 in 1980 to 111,616 in 2016. Arkansas has the 8th highest number of incarcerated women in the nation, 60% higher than the national average. As the number of incarcerated women has risen, so too has the need for jails and prisons to address women's health needs, including pregnancy, childbirth, and postpartum care. Nationally, over 75% of incarcerated women are of childbearing age and about are pregnant upon intake. However, little is known about the population of women who have become incarcerated while pregnant in Arkansas - including the outcomes of these women and their children and how these outcomes may vary in relation to services that are received during incarceration. This research study aims to first expand knowledge on incarcerated women in Arkansas by using administrative data to retrospectively examine the health status and outcomes of pregnant women who were incarcerated in state prison by Arkansas over a five-year period (Aim 1). Then, the investigators will lay the groundwork for and subsequently analyze prospectively gathered outcomes of women in Arkansas state prisons by supplementing administratively-collected data with in-person data collection (Aim 2). This prospectively-gathered data will include records of: 1) self-report responses to surveys about their health and mental health, 2) women's participation or nonparticipation in elements of programming for incarcerated pregnant women that was recently launched by Arkansas Department of Correction in collaboration with the study PI (i.e., Growing Together), and 3) self-report responses to surveys about the elements of Growing Together. The Growing Together program elements that are currently active and that will be evaluated under this protocol are a lactation program, lactation education, and a mental health support group. The investigators will also pilot and conduct an open-label evaluation of an additional program component, doula support, with a sample of up to 24 incarcerated women (Aim 3). Assessment of the program components in Aims 2 and 3 will focus on evaluating acceptability to the population and feasibility.

Start: July 2021