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. ^{1 2 3 4 5}

Is telehealth intervention safe for caregivers?

Telehealth interventions, including those for caregivers, have been shown to be safe and well-received, with studies reporting high satisfaction and usability among participants. These interventions are generally considered a safe way to support mental health and well-being. ^{1 2 4 6 7}

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. ^{1 3 4 8 9}

Research Team

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

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 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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Dr. L. Ebony Boulware

Wake Forest University Health Sciences

Chief Medical Officer since 2022

MD from Duke University School of Medicine, MPH from Johns Hopkins Bloomberg School of Public Health

Dr. Julie Ann Freischlag

Wake Forest University Health Sciences

Chief Executive Officer since 2020

BS from University of Illinois, MD from Rush University

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

The Children's Attention-Deficit Hyperactivity Disorder Telemental Health Treatment Study: Caregiver Outcomes. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A systematic review of telehealth tools and interventions to support family caregivers. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a telehealth service delivery model for treating attention-deficit/hyperactivity disorder: a community-based randomized controlled trial. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Long-Term Effectiveness of Guided Self-Help for Parents of Children With ADHD in Routine Care-An Observational Study. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Work-MAP Telehealth Metacognitive Work-Performance Intervention for Adults With ADHD: Randomized Controlled Trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

ADHDCoach-a virtual clinic for parents of children with ADHD: Development and usability study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Outcomes and Acceptability of Telehealth-Based Coaching for Caregivers in Asian Countries. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Financial interventions for family caregivers of individuals with chronic illness: a scoping review protocol. [2023]