Telehealth Intervention for Financial Hardship in Caregivers
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Wake Forest University Health Sciences
Disqualifiers: Patient declines medical record access
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
This clinical trial assesses whether resource identification for primary caregivers can affect financial stress, quality of life, depression, and the general belief in the ability to cope with daily life. Caregivers of patients receiving cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CS+HIPEC) demonstrate that they endure high depressive symptom burdens and financial distress. Further, they experience symptom trajectories that differ from those of patients. In short, they require differential timing of supportive interventions. This study aims to reduce financial toxicity and distress levels and to increase self-efficacy, satisfaction and engagement with care. Information gathered from this study may help researchers determine whether telehealth interventions for caregivers may increase awareness of recommended resources that could be beneficial during caregivers journey.
Will I have to stop taking my current medications?
The trial does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Telehealth Intervention, Telehealth Therapy, Virtual Behavioral Intervention, Online ADHD Support for financial hardship in caregivers?
Research shows that telehealth interventions can effectively improve mental health for caregivers, with significant improvements in depression, anxiety, and stress. Additionally, telehealth models for ADHD treatment have shown greater improvements in caregiver distress and empowerment compared to traditional care.12345
Is telehealth intervention safe for caregivers?
How is the Telehealth Intervention treatment unique for addressing financial hardship in caregivers?
The Telehealth Intervention is unique because it uses technology like video calls and online platforms to provide support and therapy remotely, making it more accessible for caregivers who may face barriers to in-person services. This approach can improve mental health and reduce stress for caregivers, offering a flexible and convenient alternative to traditional face-to-face therapy.13489
Eligibility Criteria
This trial is for primary caregivers of patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CS+HIPEC). It aims to help those experiencing high levels of depression and financial stress due to their caregiving responsibilities.Inclusion Criteria
The ability to understand and willingness to provide written informed consent
The ability to read and write English
Primary caregiver of a patient scheduled to receive CS+HIPEC
See 2 more
Exclusion Criteria
I do not allow access to my medical records.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-4 weeks
1 visit (virtual)
Intervention
Participants receive telehealth navigation intervention which may consist of referral to specific resources for caregiving experience
1 hour
1 visit (virtual)
Follow-up
Participants are monitored for outcomes such as financial distress, depression, and quality of life
24-28 months
Multiple visits (virtual)
Treatment Details
Interventions
- Telehealth Intervention (Behavioural Intervention)
Trial OverviewThe study tests if telehealth interventions, like resource identification through surveys, electronic health record reviews, and adherence to best practices can reduce financial strain and improve quality of life, self-efficacy, satisfaction with care, and coping abilities in caregivers.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1 (Telehealth intervention)Experimental Treatment3 Interventions
Participants receive telehealth navigation intervention which may consist of referral to specific resources for caregiving experience over 1 hour 1-4 weeks prior to patient's surgery.
Group II: Group 2 (Usual Care)Active Control3 Interventions
Participants receive standard caregiving experience on study.
Telehealth Intervention is already approved in United States for the following indications:
🇺🇸 Approved in United States as Telehealth Intervention for:
- Attention Deficit Hyperactivity Disorder (ADHD) in preschoolers
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Telehealth as a Psychological Intervention for Caregivers of Children with Neurodevelopmental Disorders: A Systematic Review with Effect Sizes. [2023]Caregivers of children with a neurodevelopmental disorder report increased mental health difficulties but also barriers to accessing professional support. Psychological interventions via telehealth offer an accessible method of service delivery for these families. This review is the first to quantitatively evaluate available telehealth trials designed to promote caregivers' mental health. The PubMed, PsycINFO, CINAHL, Embase and Cochrane databases (from inception until 20th May 2023) were searched for telehealth trials targeting caregiver mental health. Hedges' g effect sizes were calculated, and findings reported by symptom domain (depression, anxiety, stress, distress), telehealth format (individual vs. group), and modality (webpage, text-messaging, video). Reporting bias (QualSyst tool) and publication bias (Doi plot) were also assessed. Twelve independent studies (N = 769 caregivers), including eight controlled trials and four quasi-experimental (pre-post, single group) designs, were included. Most studies were of acceptable methodological quality. Evidence for improved mental health was found for telehealth (g range = 0.394-1.955), regardless of the method of delivery. The longevity of these effects could not, however, be determined. The present findings suggest that psychological interventions delivered by telephone and/or the internet can be used to effectively manage caregivers' mental health symptoms, although consideration must be given to an individual's treatment preferences and requirements. Further non-inferiority trials, with a diverse sample, can determine whether telehealth interventions provide a comparable alternative to face-to-face treatment. Protocol registration on Open Science Framework: https://osf.io/ctqne/ .
The Children's Attention-Deficit Hyperactivity Disorder Telemental Health Treatment Study: Caregiver Outcomes. [2022]The Children's Attention-deficit Hyperactivity Disorder (ADHD) Telemental Health Treatment Study (CATTS) tested the hypotheses that children and caregivers who received guideline-based treatment delivered through a hybrid telehealth service delivery model would experience greater improvements in outcomes than children and caregivers receiving treatment via a comparison delivery model. Here, we present caregiver outcomes. 88 primary care providers (PCPs) in seven geographically underserved communities referred 223 children (ages 5.5 - 12.9 years) to the randomized controlled trial. Over 22 weeks, children randomized to the CATTS service delivery model received six sessions of telepsychiatry and six sessions of caregiver behavior management training provided in person by community therapists who were trained and supervised remotely. Children randomized to the comparison Augmented Primary Care (APC) service model received management in primary care augmented by a single telepsychiatry consultation. Caregiver outcomes included changes in distress, as measured by the Patient Health Questionnaire (PHQ-9), Parenting Stress Index (PSI), Caregiver Strain Questionnaire (CSQ) and Family Empowerment Scale (FES). Caregivers completed five assessments. Multilevel mixed effects regression modeling tested for differences between the two service delivery models in caregiver outcomes from baseline to 25 weeks. Compared to caregivers of children in the APC model, caregivers of children in the CATTS service model showed statistically significantly greater improvements on the PHQ-9 (β = -1.41, 95 % CI = [-2.74, -0.08], p
A systematic review of telehealth tools and interventions to support family caregivers. [2018]We conducted a systematic review of studies employing telehealth interventions which focused on family caregivers' outcomes. The Embase, CINHAL, Cochrane and PubMed databases were searched using combinations of keywords including "telehealth," "telemedicine," "telecare," "telemonitoring," "caregiver" and "family." The initial search produced 4205 articles, of which 65 articles met the inclusion criteria. The articles included 52 experimental studies, 11 evaluation studies, one case study and one secondary analysis. Thirty-three articles focused on family caregivers of adult and older patients, while 32 articles focused on parental caregivers of paediatric patients. The technologies included video, web-based, telephone-based and telemetry/remote monitoring. Six main categories of interventions were delivered via technology: education, consultation (including decision support), psychosocial/cognitive behavioural therapy (including problem solving training), social support, data collection and monitoring, and clinical care delivery. More than 95% of the studies reported significant improvements in the caregivers' outcomes and that caregivers were satisfied and comfortable with telehealth. The review showed that telehealth can positively affect chronic disease care, home and hospice care.
Effectiveness of a telehealth service delivery model for treating attention-deficit/hyperactivity disorder: a community-based randomized controlled trial. [2018]To test the effectiveness of a telehealth service delivery model for the treatment of children with attention-deficit/hyperactivity disorder (ADHD) that provided pharmacological treatment and caregiver behavior training.
Long-Term Effectiveness of Guided Self-Help for Parents of Children With ADHD in Routine Care-An Observational Study. [2021]Objective:To assess long-term effectiveness of guided self-help for parents of children with ADHD under routine care conditions. Method: 6- to 12-year-old children diagnosed with ADHD were enrolled in an observational study on a 1-year telephone-assisted parent-administered behavioral intervention. N = 136 families who completed the intervention participated in a follow-up assessment. Pre-, post-, and follow-up data were analyzed by repeated measures ANOVA with planned contrasts. Clinical significance was analyzed according to the reliable change index. Results: Child ADHD symptoms (primary outcome), oppositional defiant disorder (ODD) symptoms, overall behavioral problems, and quality of life improved during the intervention. There was a further improvement in ADHD symptoms at follow-up, with a medium effect size. Improvements during treatment in ODD symptoms, overall behavioral problems, and quality of life were maintained at follow-up. Conclusion: The findings suggest that telephone-assisted self-help interventions may result in a long-term reduction of child behavior problems.
Work-MAP Telehealth Metacognitive Work-Performance Intervention for Adults With ADHD: Randomized Controlled Trial. [2023]The literature highlighted the need for evidence-based occupational therapy teleinterventions to improve work participation among adults with attention-deficit/hyperactivity disorder (ADHD). This study aimed to assess the efficacy of a self-tailored, metacognitive, telehealth intervention to enhance the performance of adults with ADHD at work (Work-MAP). The outcome measures were efficacy and satisfaction with performing self-selected work goals, executive functions, and quality of life. Participants in this randomized controlled trial were 46 adults with ADHD. Group A (n = 31) received the synchronous, hybrid-telehealth intervention in 11-weekly 1-hour individual sessions. Group B (n = 15) completed the intervention after a waiting phase. Following the intervention, participants showed and maintained significant improvements in all outcome measures (strong-to-moderate significant effects) to the 3-month follow-up. The Work-MAP teleintervention appears effective for improving work participation (i.e., performance), executive functions, and quality of life of adults with ADHD.
ADHDCoach-a virtual clinic for parents of children with ADHD: Development and usability study. [2023]Attention-deficit/ hyperactivity disorder (ADHD) is one of the most common mental health problems in childhood. Despite the fact that evidence-based treatments exist, behavioral parent training programs are the gold standard in the care of children with ADHD, a significant percentage of parents of children with ADHD do not access such interventions. Internet-delivered interventions are effective for a range of mental health problems, however, there is limited research conducted on the efficacy of such interventions in the treatment of ADHD. Objective: The aim of this study is to present the development and feasibility of an Internet-delivered intervention for parents of children with ADHD. Methods: The intervention was based on Behavioral Parent Training and Rational Emotive Behavior Therapy. Participants were mental health specialists (N = 16) and parents of children diagnosed with ADHD (N = 24). Results: Our results indicated high usability and parental satisfaction with the intervention. Conclusion: In conclusion, an Internet-delivered intervention addressed to parents of children diagnosed with ADHD is a promising approach. Future research should investigate the efficacy of this Internet-delivered intervention in a randomized controlled trial.
Outcomes and Acceptability of Telehealth-Based Coaching for Caregivers in Asian Countries. [2023]Recent studies evaluating the effectiveness of using telehealth to train caregivers across large geographical distances in the United States and internationally indicate that this modality can increase families' accessibility to evidence-based interventions for problem behavior. In this study, experimenters and interpreters in the United States remotely coached nine caregivers of children with disabilities residing in three countries in Asia to implement functional analyses (FA) and functional communication training (FCT). Five of the nine families were culturally matched to either the experimenter or the interpreter. Problem behavior was reduced to near-zero levels for all but one participant. Furthermore, all caregivers implemented the procedures with high levels of integrity and rated the assessment and treatment as highly acceptable, regardless of cultural matching or use of interpreters. Overall, findings suggest telehealth-based caregiver coaching and caregiver-implemented FA plus FCT is feasible and acceptable in Asia.
Financial interventions for family caregivers of individuals with chronic illness: a scoping review protocol. [2023]There are 53 million caregivers in the USA providing informal care for individuals with chronic illnesses. These caregivers contribute significantly to the healthcare system, yet they may experience adverse consequences due to caregiving, including financial burden. The purpose of this scoping review is to fill a research gap on understanding the nature and effect of financial interventions for family caregivers.