Clinical Trials Logo

Clinical Trial Summary

This pilot study will investigate the feasibility of using a digital health application, Communication, Learning, Advocacy, Resources and Expertise (CLARE), in training and support of family and friends (i.e., caregivers) of older adults with Covid in home caregiving, and in their self-care. The study's mixed method, one group, pre-post design will recruit 50 caregivers who are at least 65 years of age at Duke University Hospital. Caregivers must be the primary person who will aid patients at home after hospital discharge. The caregiver will receive a short message service (SMS) link and/or e-mail to download the digital health application on their own smartphone or tablet. The study team will guide the caregiver through features of the application including how to complete demographics questionnaire and surveys for caregiving preparedness, and how to reply to reminders. For data collection, the investigators will use CLARE analytics for feasibility analysis, interview data to determine modifiable factors that will enhance CLARE use, and pre-post preparedness in caregiving data to explore preliminary efficacy of CLARE.


Clinical Trial Description

The proposed pilot will investigate the feasibility of using a digital health application, Communication, Learning, Advocacy, Resources and Expertise (CLARE), in training and support of family and friends (i.e., caregivers) of older adults, many of whom are elders themselves. The training and support will focus on discharge care of patients including early mobility, and self-care among caregivers through walking activities. The investigators have three study aims: (1) to test the feasibility of CLARE in caregiving training and support during the early days of hospital discharge; (2) to use the Unified Theory of Acceptance and Use of Technology behavioral framework (UTAUT) to determine factors that will promote intent and use of CLARE among elder caregivers; and (3) (exploratory) - to explore preliminary efficacy of CLARE in improving caregiving preparedness to inform effect size and variability in outcome for future work. Each caregiver will receive a unique invitation code to use the CLARE app. The study team will guide the caregiver through features of the application including how to complete demographics questionnaire and surveys for caregiving preparedness, and how to reply to reminders. CLARE will feature materials on hospital discharge preparation, Covid care, and caregiver self-care, all vetted by the Duke University Health System (DUHS) Patient and Family Education department. Existing teaching on Covid covers isolation; quarantine; home sanitization; and monitoring for Covid symptoms such as cough, fever, fatigue, and shortness of breath. Content will be reviewed and amended to reflect the latest Center for Disease Control (CDC) guidelines for Covid care at the time of pilot implementation. CLARE will also include reminders on examining the After-Visit-Summary to determine home medications and information on follow-up appointments with patient's primary care providers. For caregiver support, the investigators have included self-care strategies to manage anxiety and stress. For this pilot, the investigators will add two modules. The first additional module will pertain to the importance of early mobility of patients with instructions on how to assist based on functional capacity: independent, partial assistance, dependent. For example, for physically independent patients, the investigators will provide progressive distance walking activities from Day 1 to Day 7 (e.g., walking to sitting at the dining table to eat meals on Day 1 to walking around neighborhood as tolerated on Day 7). For patients needing partial assistance, the investigators will include body mechanics for caregivers as they assist patients during walking or from sitting to standing. And, for physically dependent patients, CLARE will provide teaching on passive range of motion for early day of discharge to progress to active range of motion. The second additional module will be for caregiver self-care. The investigators will include the importance of walking and provide daily reminders for activities that will involve walking. CLARE will provide caregiver training and support up to 7 days after hospital discharge. Seven days is intentional as post-hospital clinic visit frequently happens within this period where formal handoff of care from hospital to primary care occurs. The investigators will push daily task reminders in the morning followed by words of encouragement in the afternoon to hopefully sustain caregivers' motivation to continue using CLARE. The investigators will encourage caregivers to use CLARE's chat functionality to communicate with the study team ad lib. The investigators will promptly document and forward all medical questions to hospital collaborators that include physicians, nurses, case managers, and physical/occupational therapists. To be eligible, caregivers must be the primary person who will aid patients at home after hospital discharge. Caregivers must be at least 65 years of age and provide care to a loved one who is also 65 years and above. Caregivers must possess a smart phone or a tablet. Caregivers will be selected by the healthcare team at Duke Hospital in units that have patients diagnosed with Covid-19. Caregivers must be able to speak and read in English. Subject recruitment will follow the same workflow used in the team's recent Covid caregiver trial. Hospital providers will use the caregiver consult template the investigators developed in Epic once they have ascertained the presence of a caregiver on an elder patient admitted with a Covid diagnosis and planned discharge home. The consult template includes data points to collect caregiver names and contact information. Once the study team receives the consult via Epic's System List, the team will contact the caregiver by phone to assess eligibility and interest in participation. If interested, the investigators will obtain verbal consent by phone. To begin caregiver training, the caregiver will receive a short message service link (SMS) and/or e-mail to download the digital health application on their own smartphone or tablet. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05877586
Study type Interventional
Source Duke University
Contact Cristina Hendrix, DNS
Phone 9196849358
Email cristina.hendrix@duke.edu
Status Recruiting
Phase N/A
Start date October 1, 2023
Completion date September 30, 2024

See also
  Status Clinical Trial Phase
Completed NCT02250911 - Care For The Cancer Caregiver: A Meaning-Based Workshop To Help Manage Caregiver Burden N/A
Completed NCT00362284 - Comprehensive Support for Alzheimer's Disease Caregivers N/A
Recruiting NCT04052074 - Complementary Therapy in Home Palliative Care Patients and Their Caregivers N/A
Recruiting NCT05949047 - Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease N/A
Completed NCT04491110 - Intervention to Improve Quality of Sleep of Palliative Patient Carers in the Community: Clinical Trial N/A
Completed NCT04416529 - Tele-Mindfulness for Dementia's Family Caregivers: a Randomized Trial With a Usual Care Control Group N/A
Recruiting NCT05302245 - A Longitudinal Examination of Unpaid Caregivers of Acquired Brain Injury (ABI) Survivors in Nova Scotia
Recruiting NCT03745235 - A Study Comparing the Influence of a Mindfulness-based Stress Reduction Program vs. Routine Management on Psychological Variables and Biological Markers Related to Immuno-inflammation Associated With Psychological Stress in Caregivers of Patients With Severe Psychiatric Disorders N/A
Completed NCT00271375 - Evaluating the Carter Institute Caregiver Education Program at the VA N/A
Completed NCT04114864 - A Primary Prevention Intervention for the Promotion of Psycho-social Wellbeing in Adolescent Young Carers: Phase 1/Phase 2
Completed NCT06038877 - Opinions and Representations of Advanced Practice Nurses (IPA) in Nephrology in France on Clinical Research
Recruiting NCT03850613 - Alleviating Caregivers' Stress Through an E-painting Mobile Application N/A
Completed NCT02585232 - Optimizing Dementia Care N/A
Completed NCT04556591 - Mobile Technology and Data Analytics to Identify Real-time Predictors of Caregiver Well-Being N/A
Terminated NCT05590273 - Forgotten Voices: Addressing Unmet Needs in Brain Tumor Caregivers N/A
Completed NCT00558402 - Meditation or Education for Alzheimer Caregivers Phase 2
Terminated NCT04184037 - iMeditate at Home for Older Adults With Mild Cognitive Impairment and Caregivers N/A
Terminated NCT03857308 - Eudaimonia and Sleep: Effects of a Mindfulness Intervention in Caregivers of People With Dementia N/A
Recruiting NCT02861625 - CONDOL01: Evaluation on the Experience of Bereavement, of a Medical Consultation, Proposed by a Letter of CONDOLence to the Patients' Relatives Versus Standard Practice After the Death of the Patient
Active, not recruiting NCT05173922 - "Safety in Dementia": An Online Caregiver Intervention N/A