Telehealth Intervention for Financial Hardship in Caregivers

Overseen By Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Patient declines medical record access

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether telehealth (online health support) can help caregivers of patients undergoing specific cancer surgery reduce financial stress and improve quality of life. The trial focuses on providing caregivers with resources and support to manage their unique challenges. Participants will either receive a telehealth intervention (virtual behavioral intervention) with access to helpful resources or continue with their usual caregiving routine. Suitable candidates for this trial are primary caregivers for someone about to undergo particular cancer surgery and have access to a computer or smartphone.

As an unphased trial, this study offers a unique opportunity to access innovative support methods that could significantly enhance the caregiving experience.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications.

What prior data suggests that this telehealth intervention is safe for caregivers?

Past studies have found telehealth services for caregivers to be safe and well-liked. Most caregivers reported satisfaction and comfort with these services, finding the tools easy to use. Research has shown that over 95% of studies reported significant improvements in caregiver well-being. This indicates that telehealth is both helpful and safe for caregivers. Therefore, based on past research, participating in this trial for a telehealth service should not raise any safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this telehealth intervention because it offers a novel way to support caregivers experiencing financial hardship. Unlike traditional in-person support services, this intervention is delivered remotely, making it more accessible and convenient for caregivers who may have time or transportation constraints. Additionally, the intervention is personalized, with participants receiving tailored referrals to resources that can directly address their unique caregiving challenges, all before the patient's surgery. This proactive approach not only aims to ease financial stress but also enhances the overall caregiving experience.

What evidence suggests that this telehealth intervention is effective for reducing financial stress in caregivers?

Studies have shown that telehealth programs can effectively improve mental health for caregivers. Participants in these programs have reported feeling less depressed and anxious. In this trial, Group 1 will receive a telehealth intervention, which may include referrals to specific resources for their caregiving experience. Research also shows that telehealth helps caregivers by providing regular support and expert advice. This method has been linked to better outcomes for caregivers, such as reduced stress and improved ability to handle caregiving challenges. Overall, telehealth offers a promising way to support caregivers' mental and emotional well-being. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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

Exclusion Criteria

I do not allow access to my medical records.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Telehealth Intervention

Trial Overview The 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.

How Is the Trial Designed?

Group I: Group 1 (Telehealth intervention) Experimental Treatment 3 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 Control 3 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

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A systematic review of 65 studies on telehealth interventions for family caregivers found that over 95% reported significant improvements in caregiver outcomes, indicating high efficacy of these interventions.

Caregivers expressed satisfaction and comfort with telehealth technologies, which included various methods like video and telephone, suggesting that telehealth can effectively support chronic disease management and home care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of telehealth tools and interventions to support family caregivers. Chi, NC., Demiris, G.[2018]

This scoping review aims to explore the financial interventions available for family caregivers of individuals with chronic illnesses, addressing a significant gap in research regarding their financial burdens.

The study will systematically analyze articles published from 1997 to the present, focusing on the nature, scope, and effects of these financial interventions, with findings expected to be shared in scholarly journals and conferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Financial interventions for family caregivers of individuals with chronic illness: a scoping review protocol. Thomas Hebdon, MC., Phan, CTT., Phillips, C., et al.[2023]

A review of 12 studies involving 769 caregivers found that telehealth psychological interventions significantly improve mental health symptoms such as depression, anxiety, and stress, with effect sizes ranging from 0.394 to 1.955.

Telehealth interventions, whether delivered via phone or internet, are effective for managing caregivers' mental health, but further research is needed to assess the long-term effects and compare these methods to traditional face-to-face therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth as a Psychological Intervention for Caregivers of Children with Neurodevelopmental Disorders: A Systematic Review with Effect Sizes. Kelson, E., Dorstyn, D.[2023]

A study involving 136 families of children aged 6 to 12 with ADHD showed that a telephone-assisted self-help intervention led to significant improvements in ADHD symptoms, oppositional defiant disorder symptoms, and overall behavioral problems during the intervention and maintained these improvements at follow-up.

The intervention not only improved child behavior problems but also enhanced the quality of life for families, indicating that guided self-help can be an effective long-term strategy for managing ADHD in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Effectiveness of Guided Self-Help for Parents of Children With ADHD in Routine Care-An Observational Study. Döpfner, M., Liebermann-Jordanidis, H., Kinnen, C., et al.[2021]

Telehealth coaching effectively trained nine caregivers of children with disabilities across three Asian countries, leading to a significant reduction in problem behaviors to near-zero levels for most participants.

Caregivers implemented the training procedures with high integrity and found the assessment and treatment highly acceptable, indicating that telehealth is a feasible and culturally adaptable method for delivering interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and Acceptability of Telehealth-Based Coaching for Caregivers in Asian Countries. Tsami, L., Nguyen, JT., Alphonso, N., et al.[2023]

An Internet-delivered intervention for parents of children with ADHD, based on Behavioral Parent Training and Rational Emotive Behavior Therapy, showed high usability and satisfaction among participants, including 24 parents and 16 mental health specialists.

This promising approach suggests that online programs could help increase access to effective ADHD treatments for parents, but further research is needed to evaluate its efficacy in a randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ADHDCoach-a virtual clinic for parents of children with ADHD: Development and usability study. Păsărelu, CR., David, D., Dobrean, A., et al.[2023]

A randomized controlled trial with 46 adults with ADHD demonstrated that the Work-MAP telehealth intervention significantly improved work performance, executive functions, and quality of life over an 11-week period.

Participants maintained these improvements for up to 3 months after the intervention, indicating the long-term efficacy of this self-tailored, metacognitive approach to occupational therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Work-MAP Telehealth Metacognitive Work-Performance Intervention for Adults With ADHD: Randomized Controlled Trial. Grinblat, N., Rosenblum, S.[2023]

The Children's ADHD Telemental Health Treatment Study (CATTS) involved 223 children and showed that a telehealth service model providing pharmacological treatment and caregiver training was significantly more effective than traditional primary care for improving ADHD symptoms and related impairments.

Children receiving telehealth treatment demonstrated greater improvements in attention, hyperactivity, and overall role performance compared to those receiving augmented primary care, highlighting the potential of telehealth to enhance access to effective ADHD care in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a telehealth service delivery model for treating attention-deficit/hyperactivity disorder: a community-based randomized controlled trial. Myers, K., Vander Stoep, A., Zhou, C., et al.[2018]

In a study involving 223 children with ADHD and their caregivers, the hybrid telehealth service delivery model (CATTS) led to significantly greater improvements in caregiver distress compared to a standard care model, as measured by various assessment tools over 25 weeks.

The improvements in caregiver outcomes were linked to reductions in child ADHD symptoms and oppositional defiant disorder (ODD) behaviors, indicating that addressing the child's condition can positively impact caregiver well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Children's Attention-Deficit Hyperactivity Disorder Telemental Health Treatment Study: Caregiver Outcomes. Vander Stoep, A., McCarty, CA., Zhou, C., et al.[2022]

Citations

1. withpower.com withpower.com/trial/telehealth-intervention-for-financial-hardship-in-caregivers-ef150

Telehealth Intervention for Financial Hardship in Caregivers Research shows that telehealth interventions can effectively improve mental health for caregivers, with significant improvements in depression, anxiety, and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4458734/

Teletherapy Delivery of Caregiver Behavior Training for ... Background: Preliminary studies suggest that videoteleconferencing (VTC) may be an effective means to deliver behavioral interventions to families.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11532349/

Telehealth implementation for children with attention deficit ... The objective of this research was to examine current telehealth practices in managing children with attention deficit hyperactivity disorder (ADHD)

4. sciencedirect.com sciencedirect.com/science/article/pii/S2451958825001186

Efficacy of digital mental health interventions for attention- ... Research shows that telehealth can reduce ADHD symptoms and alleviate caregiver burden by providing consistent support and professional guidance (Lakes et al., ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2021/3518050

Telehealth Interventions for Family Caregivers of Persons ... Conclusion. Telehealth is an effective tool in delivering caregiver interventions and leads to significant improvement in caregiver outcomes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4486048/

A systematic review of telehealth tools and interventions to ... More than 95% of the studies in our review reported significant improvements in the caregivers' outcomes and that caregivers were satisfied and comfortable ...

7. researchgate.net researchgate.net/publication/351804828_Telehealth_Interventions_for_Family_Caregivers_of_Persons_with_Chronic_Health_Conditions_A_Systematic_Review_of_Randomized_Controlled_Trials

Telehealth Interventions for Family Caregivers of Persons ... Conclusion: Telehealth is an effective tool in delivering caregiver interventions and leads to significant improvement in caregiver outcomes. Telephone was used ...