NCT03800238: TPTC

Telehealth Powerful Tools for Caregivers Effectiveness Study

Completed NA Last updated 29 October 2020

What this trial tests

NA trial testing Telehealth Delivery Format in Caregivers in 115 participants. Completed in 8 October 2020.

Timeline

1 February 2019

Primary endpoint
8 October 2020

8 October 2020

Quick facts

Lead sponsor	Concordia University Wisconsin
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	115
Start date	1 February 2019
Primary completion	8 October 2020
Estimated completion	8 October 2020
Sites	13 locations across Canada, United States

Drugs / interventions tested

• Telehealth Delivery Format
• Standard Delivery Format

Conditions studied

• Caregivers — all drugs for Caregivers →

Sponsor

Concordia University Wisconsin

Who can join

18 and older, any sex, with Caregivers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 research and add additional outcomes meaningful to caregiver wellness. Statistical analysis will include descriptive statistics and a mixed design analysis of variance including repeated measures to examine differences in the variables of interest over time.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The effectiveness of telehealth for a caregiver wellness program.
   Serwe KM, Walmsley AL. · · 2023 · cited 4× · PMID 34233538 · DOI 10.1177/1357633x21994009