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COMPLETED NA

Telehealth Powerful Tools for Caregivers Effectiveness Study

NCT03800238 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this research is to examine the efficacy of telehealth as a delivery format for an education-based caregiver wellness program focusing on self-care. The study will examine two research questions. 1) Are outcomes equivalent for caregivers in an education based-wellness program delivered via telehealth and one delivered in person as measured by a general rating of health, the Center for Epidemiologic Studies Depression Scale - Revised (CESD-R), self-care behaviors (health self-care neglect, frequency of stress management and relaxation activities, and exercise frequency), self-efficacy, use of community resources, and the Bakas Caregiving Outcomes Scale (BCOS)? 2) Is class attendance equivalent for classes delivered via telehealth and in person? This research involves a specific education-based caregiver wellness program called Powerful Tools for Caregivers (PTC). PTC is an evidence-based six-week program that addresses caregiver health by promoting self-care. Collaborating community organizations offer the program at little to no cost. This study will employ a quasi-experimental nonequivalent pretest-posttest design to compare outcomes from in-person to telehealth delivered PTC classes. PTC classes are conducted by a pair of class leaders who model concepts. Each pair of class leaders will conduct both a telehealth and in-person PTC class. Collaborating community organizations will recruit 105 caregivers to attend PTC classes delivered by 7 pairs of class leaders. Telehealth classes will use VSee software to allow caregivers to participate in the PTC program synchronously via secure videoconferencing from their own home. VSee is a free software program designed to deliver secure telehealth services. Class leaders will guide participants in installation of the software on their home computer. Participants will undergo assessment one week before and one week after the PTC program, and at six-month follow up. Outcome measures replicate previous PTC res

Conditions Studied

Interventions

  • BEHAVIORAL Telehealth Delivery Format
  • BEHAVIORAL Standard Delivery Format

Study Locations (13)

California

  • OPICA Adult Day Program — Los Angeles
  • Health Projects Center — Santa Cruz

Florida

  • Tampa General Hospital — Tampa

Idaho

  • Southeast Idaho Council of Governments Inc — Pocatello

Iowa

  • Iowa State University (ISU) Extension and Outreach — Webster City

Michigan

  • Michigan State University — Grand Rapids

Minnesota

  • Lutheran Social Service — Moorhead

Nebraska

  • Executive Services Corps - NE — Plattsmouth

New Hampshire

  • Concord Regional Visiting Nurse Association (VNA) — Concord

Trial Details

FieldValue
Enrollment Target 115 participants
Start Date 2019-02-01
Est. Completion 2020-10-08
Phase NA

Sponsor

Concordia University Wisconsin

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03800238

The ClinicalTrials.gov registry entry for NCT03800238 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Concordia University Wisconsin, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Caregivers appearing as the primary indexed condition, and to 2 interventions — of which Telehealth Delivery Format is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03800238 reports 13 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Idaho. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03800238 about?

NCT03800238 is a clinical study titled "Telehealth Powerful Tools for Caregivers Effectiveness Study". The purpose of this research is to examine the efficacy of telehealth as a delivery format for an education-based caregiver wellness program focusing on self-care. The study will examine two research questions. 1) Are outcomes equivalent for caregivers in an education based-wellness program delivere...

What is the current status of trial NCT03800238?

This trial is currently completed. It is a NA study. The enrollment target is 115 participants. The study started on 2019-02-01. Estimated completion is 2020-10-08.

What conditions does trial NCT03800238 study?

This clinical trial studies the following conditions: Caregivers. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03800238?

The interventions under investigation include: Telehealth Delivery Format (BEHAVIORAL), Standard Delivery Format (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03800238?

This trial is sponsored by Concordia University Wisconsin, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03800238 being conducted?

This trial has 13 study locations across California, Florida, Idaho, Iowa, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial