Telehealth Intervention for Surgical Preparedness

(TIPPS-Latina Trial)

Recruiting at 1 trial location

Overseen By Gabriela Halder, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Male, Under 18, Non-Hispanic, others

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: Unknown

357 Participants Needed

Trial Summary

What is the purpose of this trial?

There are 3 aims of this study. In Aim 1 community patient partners will be enrolled to help guide the research being performed in all of the aims. Investigators will also administer a survey that will help determine factors associated with surgical preparedness. In Aim 2 investigators will develop an intervention to increase surgical preparedness using Human Centered Design Methods. Aim 3 will pilot test the intervention using mixed methods to determine feasibility and implementation outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Telehealth Intervention for Surgical Preparedness treatment?

Research shows that telehealth services, like those used for ADHD treatment, can improve caregiver outcomes and reduce stress. Additionally, telehealth-based cognitive-behavioral therapy has been effective in reducing symptoms of depression, anxiety, and stress, suggesting that similar approaches could help with surgical preparedness. ^{1 2 3 4 5}

Is telehealth intervention generally safe for humans?

The research on telehealth interventions, particularly for ADHD, suggests they are generally safe for humans. These studies focus on improving symptoms and quality of life without reporting significant safety concerns. ^{4 6 7 8 9}

How does the Telehealth Intervention for Surgical Preparedness differ from other treatments for surgical preparedness?

The Telehealth Intervention for Surgical Preparedness is unique because it uses telehealth technology to prepare patients for surgery, potentially offering more convenient and accessible support compared to traditional in-person methods. This approach can provide personalized guidance and education remotely, which may enhance patient readiness and reduce the need for multiple hospital visits. ^{4 7 9 10 11}

Research Team

Gabriela Halder, MD, MPH

Principal Investigator

Assistant Professor

Eligibility Criteria

This trial is for Latinas dealing with uterovaginal prolapse or bladder control issues. It aims to help them prepare for surgery using a telehealth intervention. Participants will be involved in guiding the research and providing feedback on the intervention's development.

Inclusion Criteria

I regularly perform surgeries for pelvic issues like prolapse or incontinence.

Patients who self-report as Hispanic ethnicity

I am scheduled for surgery to address a pelvic condition.

Exclusion Criteria

I am under 18 years old.

Urogynecologists who do not routinely perform urogynecologic surgery

Patients who self-report as not of Hispanic ethnicity

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Discover Phase

Investigators identify preferences for refinement of TIPPS-Latina and its contextual deployment using mixed methods

4-6 weeks

Design/Build Phase

Investigators use an iterative process to generate, modify, and adapt the intervention

4-6 weeks

Test Phase

Pilot testing of TIPPS-Latina using a mixed methods approach to determine feasibility and implementation outcomes

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after surgery

6-8 weeks

Postoperative Visit

Treatment Details

Interventions

• Telehealth Intervention

Trial Overview The study tests a new telehealth program designed to get patients ready for surgery related to prolapse conditions. The program's effectiveness will be evaluated through surveys, design methods, and pilot testing with community input.

Participant Groups

Group I: Telehealth intervention Experimental Treatment 1 Intervention

Patient scheduled to undergo urogynecologic surgery will receive routine preoperative counseling in addition to the modified telehealth intervention.

Group II: Routine Preoperative Counseling Active Control 1 Intervention

Participants scheduled to undergo urogynecologic surgery will receive routine preoperative counseling.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

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]

Many children experience significant anxiety and pain during outpatient surgery, and current preparation programs are often generic and not tailored to individual needs.

The development of tailored, web-based behavioral preparation programs could improve children's coping skills and reduce anxiety and pain, leading to better recovery outcomes and future medical interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating perioperative anxiety and pain in children: a tailored and innovative approach. Fortier, MA., Kain, ZN.[2022]

In a study of 638 pediatric patients undergoing ambulatory surgery, having parents present during anesthesia induction significantly reduced postoperative maladaptive behavioral changes compared to those who were not premedicated or only given midazolam.

The combination of parental presence and midazolam (PPIA + MDZ) was particularly effective, with a higher odds ratio for reducing behavioral issues, especially in children under 5 years old.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental Presence during Induction of Anesthesia and Emergence Delirium Influence the Incidence of Postoperative Maladaptive Behavioral Changes. Gil Mayo, D., Sanabria Carretero, P., Gajate Martin, L., et al.[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]

The innovative telehealth program effectively identifies and engages patients with behavioral health issues, leading to significant reductions in symptoms of depression, anxiety, and stress.

A retrospective evaluation showed high patient satisfaction and demonstrated the program's national reach, highlighting its potential to improve clinical outcomes for patients with comorbid medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Telehealth to Implement Cognitive-Behavioral Therapy. Dent, L., Peters, A., Kerr, PL., et al.[2019]

In a pilot study involving 21 children with ADHD, blended parent training (online program with therapist support) was not as effective as traditional face-to-face parent training in reducing behavioral problems.

Parents using the blended approach had higher dropout rates and lower satisfaction compared to those in the face-to-face group, and therapists spent significantly less time with parents in the blended condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-directed or therapist-led parent training for children with attention deficit hyperactivity disorder? A randomized controlled non-inferiority pilot trial. Breider, S., de Bildt, A., Nauta, MH., et al.[2022]

A collaborative digital mental health intervention (DMHI) showed promising results in reducing symptoms of inattention and hyperactivity in children and adolescents with ADHD, with 71% of participants improving in inattention and 60% in hyperactivity after an average of 5.52 months of care.

The study found that longer duration of care was associated with greater reductions in symptom severity, indicating that ongoing support may enhance treatment outcomes for ADHD, although improvements in oppositional symptoms were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Digital Measurement-Based Care to Address Symptoms of Inattention, Hyperactivity, and Opposition in Youth: Retrospective Analysis of Bend Health. Lawrence-Sidebottom, D., Huffman, LG., Huberty, J., et al.[2023]

A randomized controlled trial with 22 participants showed that group parent training for ADHD delivered via videoconferencing is as effective as traditional face-to-face training, improving parents' disciplinary practices and children's global functioning.

Parents in the videoconference group reported statistically greater improvements in hyperactive symptoms compared to the face-to-face group, indicating that this method is not only effective but also well-accepted by parents, making it a valuable option for areas lacking ADHD treatment services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study on the effectiveness of videoconferencing on teaching parent training skills to parents of children with ADHD. Xie, Y., Dixon, JF., Yee, OM., et al.[2013]

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]

Telephone-based coping skills training for patients with chronic obstructive pulmonary disease improved psychological and somatic quality of life, but did not reduce mortality or rehospitalization compared to an education control.

A web-based distress management program for patients receiving an implantable cardioverter defibrillator showed no significant improvement in psychological outcomes compared to usual care, highlighting the need for careful trial design in telehealth interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distance therapy to improve symptoms and quality of life: complementing office-based care with telehealth. Kroenke, K.[2018]

A telehealth parent coaching program consisting of ten weekly sessions significantly improved occupational performance and executive function scores in children with ADHD, with the exception of Shift and Emotional Control.

The program also enhanced parent self-efficacy, indicating that telehealth coaching can be a valuable support for families dealing with ADHD and related challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Telehealth Parent Coaching on Occupational Performance and Executive Function of Children with Attention-Deficit/Hyperactivity Disorders, and Parent Self-Efficacy: A Preliminary Study. Pijarnvanit, P., Sriphetcharawut, S.[2023]

References

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

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

2. France pubmed.ncbi.nlm.nih.gov

Treating perioperative anxiety and pain in children: a tailored and innovative approach. [2022]

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

Parental Presence during Induction of Anesthesia and Emergence Delirium Influence the Incidence of Postoperative Maladaptive Behavioral Changes. [2023]

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

Using Telehealth to Implement Cognitive-Behavioral Therapy. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Self-directed or therapist-led parent training for children with attention deficit hyperactivity disorder? A randomized controlled non-inferiority pilot trial. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Using Digital Measurement-Based Care to Address Symptoms of Inattention, Hyperactivity, and Opposition in Youth: Retrospective Analysis of Bend Health. [2023]

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

A study on the effectiveness of videoconferencing on teaching parent training skills to parents of children with ADHD. [2013]

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

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

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

Distance therapy to improve symptoms and quality of life: complementing office-based care with telehealth. [2018]

11. England pubmed.ncbi.nlm.nih.gov

The Effects of Telehealth Parent Coaching on Occupational Performance and Executive Function of Children with Attention-Deficit/Hyperactivity Disorders, and Parent Self-Efficacy: A Preliminary Study. [2023]