Clinical Research Directory

Improving Needs Among Older Adults

Millions of older adults receive care in intensive care units (ICUs) annually. However, the quality and accessibility of ICU-based palliative care is highly variable across hospitals and clinicians, due in part to specialists' limited workforce and geographic inconsistency. To address these gaps, the investigators developed an innovative mobile app-based primary palliative care intervention called ICUconnect. ICUconnect facilitates families' and patients' self-report of actual palliative care needs across all core domains of palliative care quality, provides ICU clinicians with a scalable digital infrastructure for coordinating consistent and personalized needs-targeted care, and provides a variety of informational supports relevant to each user's role. In this RCT, the investigators will test ICUconnect vs. usual care control among 350 patient-family member dyads with elevated baseline levels of unmet palliative care need in a 4-site network serving a diverse population (Duke, Medical University of South Carolina, University of Alabama at Birmingham, Columbia). The specific aims are to: (1) Test the efficacy of ICUconnect vs. usual care control in improving palliative care needs and other person-centered outcomes including psychological distress, (2) Determine participant characteristics associated with a greater treatment response using a heterogeneity of treatment effects approach, and (3) Ensure off-the-shelf intervention readiness for implementation using a mixed-methods integration of qualitative analysis of semi-structured trial participant interviews and quantitative RE-AIM implementation framework-informed trial data.

Biomechanical Validation of the CATT

As of 2020, 53 million Americans provide unpaid care to an individual with a disability. One commonly performed activity of daily living (ADL) provided by informal caregivers is assisted transfers, which requires moving an individual from one surface to another. Approximately 94% of informal caregivers who assist with ADLs to persons with adult-onset chronic physical disabilities affecting mobility reported musculoskeletal discomfort, with pain and discomfort made worse by performing caregiving activities. Although many informal caregivers assist with transfers, most have never received any formal training in proper manual lifting or mechanical lifting techniques. Improper transfer techniques can be detrimental to not only caregiver health but also to the persons they assist resulting in shoulder injury, bruising and pain from manual lift techniques, hip fractures from falls, and skin tears from shear force that occurs with sliding during transfers. Current standard of care provides limited in-person training of caregivers, as most of the rehabilitation process is client-focused. When training is provided clinicians have no means to objectively evaluate if proper techniques are being performed at discharge or when the caregiver and care recipient return home. For this reason, an outcome measure called the Caregiver Assisted Transfer Technique Instrument (CATT) was developed to provide a quick, objective way to evaluate proper technique of caregivers who provide transfer assistance to individuals with disabilities. The CATT evaluates the caregiver's performance on setup, quality of the task performance, and results. After a formal assessment through stakeholder review involving clinicians, informal caregivers, and individuals with physical disabilities who require transfer assistance, the CATT was expanded to include two versions; one that evaluates manual lift technique (CATT-M) and one that evaluates mechanical lift techniques (CATT-L). However, the CATT must undergo further testing with informal caregivers and the individuals they assist to determine if the CATT is a reliable, valid, and responsive tool for identifying skill deficits in caregivers performing assisted transfers. The purpose of this study is to establish the psychometric properties (reliability, validity, and responsiveness) of the CATT and to evaluate the effects of an individualized training session for participants who have transfer technique deficits as identified by the CATT. The long-term goal of this research is to develop the CATT so that it can be used as an objective indicator of transfer performance as well as guide training and educational interventions for informal caregivers to reduce the risk of musculoskeletal pain and injury associated with assisted transfers.

A Daily-Activity-Focused, Strategy-Based Educational Programme for Informal Dementia Carers

This study will assess the impact of the Dementia Carer Education Programme on the caregiving burden of informal dementia carers. Ninety informal dementia carers along with their care-recipients will be recruited and randomised to the experimental and control groups. All recruited dementia carers in the experimental group will receive the Dementia Carer Education Programme and the control group will receive usual carer support, both including one face-to-face education session and four follow-up sessions over 7 weeks. Caregiving burden will be assessed after receiving the programme. Statistical analysis of caregiving burden will follow the intention-to-treat principle, employing paired t-tests and linear modelling.

Comparison of the Effectiveness of High Fidelity Simulation and Low Fidelity Simulation in Active External Bleeding Control Management of Caregivers of Elderly Individuals

The elderly population is increasing worldwide. Due to the increase in the elderly population, emergencies related to ageing are also encountered more frequently. One of these emergencies is trauma in the elderly. Traumas are frequently seen in elderly individuals due to physiological deficiencies related to aging as well as environmental factors. External bleeding caused by trauma is also encountered. If first aid to stop active external bleeding is not administered in a timely and correct manner, death due to bleeding can occur. Nowadays, elderly individuals live either with their families, alone, or in institutions. In the event of external bleeding, either the individual themselves, caregiving family members, or staff at the institution should be able to perform first aid to stop the bleeding. Elderly individuals may not be able to perform first aid due to cognitive and neurological deficiencies. The ability of caregivers to provide first aid can be life-saving. If caregivers of elderly individuals are trained in first aid for external bleeding, they can quickly and correctly administer first aid to stop the bleeding. First aid training often consists of didactic education and demonstrations. A training strategy that ensures knowledge retention and skill acquisition is simulation training. This study aims to evaluate and compare the effectiveness of high-fidelity simulation and low-fidelity (Visually Enhanced Mental Simulation - VEMS) simulation in the skills of caregivers for elderly individuals in managing active external bleeding control. The population of the study will consist of non-health professional caregivers of elderly individuals living in Antakya district of Hatay province. The sample size, calculated using the G Power program, has been determined to include 30 caregivers of elderly individuals. The study consists of four main work packages. In the first stage, the simulation environment will be prepared, and in the second stage, a preliminary application of the project will be conducted. In the third stage, the implementation of the research and the completion of checklists will be ensured. For this, volunteer caregivers of elderly individuals will be identified. After theoretical training is given to the participants, they will be assigned to intervention group 1 (VEMS) and intervention group 2 (high-fidelity simulation) using simple randomization. Following a pre-assessment with low-fidelity simulation, participants will undergo simulation training according to their intervention groups. Subsequently, a final assessment will be conducted using the same lowfidelity simulation. In the final stage, data analysis and interpretation of the findings will be carried out. The collected data will be analyzed statistically, and the significance level will be accepted as p\<0.05. With this study, insight will be provided into the effectiveness of VEMS and high-fidelity simulation in first aid training for active external bleeding for caregivers of elderly individuals. On the other hand, it is planned that the project results will be published in at least one article in journals indexed in the SSCI Expanded.

Effectiveness of a Dyadic Pain Management Program for Community-dwelling Older Adults with Chronic Pain

Objective: To evaluate the effectiveness of a dyadic pain management program (DPM) in reducing pain and psychological health symptoms, improving pain self-efficacy, quality of life, and physical function in older adults. Hypothesis: DPM is more effective in reducing pain and psychological health symptoms, improving pain self-efficacy, quality of life, and physical function among older adults than the usual care, upon completion of the DPM (week 8) and over time (week 16). Design and subjects: Clustered randomized controlled trial with neighborhood elderly centers (NEC) as cluster; 150 dyads (one older adults and his/her caregiver as one dyad) will be recruited from 22 NEC clusters. Each NEC will be randomly allocated to experimental group (receive DPM), control group (receive usual care and pain management pamphlet). Study instruments: Brief Pain Inventory; Pain Self-Efficacy Questionnaire; Short Form Health Survey-12; Depression, anxiety \& stress; Caregiver Burden Inventory; 6-minute walk test and process evaluation. Intervention: DPM, each session includes exercise, interactive pain management education, practices on non-drug techniques and using a WhatsApp (WhatsApp Messenger) group to encourage home-based exercise and practice of non-drug methods. Outcome measures: Pain intensity, pain self-efficacy, perceived health-related quality of life and experience in participating DPM, to be collected at baseline (T0), week 8 (T1), and week 16 (T2). Data analysis: Multilevel regression and/or Generalized Estimating Equation will be used for within-group and between- group comparisons.