Telehealth Powerful Tools for Caregivers Effectiveness Study

NCT03800238 | Completed

• 1 other identifier: ConcordiaUW
• Study Type: interventional
• Target: 115
• Locations: 2 countries
• Sites: 13

Brief 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 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.

Conditions

Caregivers

Keywords

caregiver; wellness; telehealth

Outcome Measures

Primary Outcomes (3)

• Center for Epidemiologic Studies Depression Scale - Revised (CESD-R)

  Questionnaire assessing symptoms of depression; each question is rated on a 5-point Likert scale; total scores range from zero to 80 with a higher score indicating greater symptoms of depression.

  Assessing change in response to participation in the Powerful Tools for Caregivers (PTC program): Baseline/ 1 week prior to participation in PTC program, 1 week after completion of the PTC program, and 6-months after completion of PTC program.

• Bakas Caregiving Outcomes Scale (BCOS)

  Questionnaire assessing the caregiving experience (includes both positive and negative changes related to caregiver role); each question is rated on a 7-point Likert scale; total scores can range from 15 10 105 with a higher score indicating a more positive caregiving experience.

  Assessing change in response to participation in the Powerful Tools for Caregivers (PTC program): Baseline/ 1 week prior to participation in PTC program, 1 week after completion of the PTC program, and 6-months after completion of PTC program.

• Custom created questionnaire: PTC Taking Care of You Survey

  PTC Taking Care of You Survey which includes questions related to caregiver self-efficacy, health self-care neglect, exercise frequency, relaxation frequency, and service utilization. The survey will also include caregiver demographics and questions related to socialization.

  Assessing change in response to participation in the Powerful Tools for Caregivers (PTC program): Baseline/ 1 week prior to participation in PTC program, 1 week after completion of the PTC program, and 6-months after completion of PTC program.

Study Arms (2)

Telehealth Delivery Format

EXPERIMENTAL

This group will participate in the Powerful Tools for Caregivers program using a telehealth delivery method.

Behavioral: Telehealth Delivery Format

Standard Delivery Format

ACTIVE COMPARATOR

This group will participate in the Powerful Tools for Caregivers program in person.

Behavioral: Standard Delivery Format

Interventions

Telehealth Delivery Format BEHAVIORAL

Participants will engage in a 6-week Powerful Tools for Caregivers program delivered via telehealth.

Telehealth Delivery Format

Standard Delivery Format BEHAVIORAL

Participants will engage in a 6-week Powerful Tools for Caregivers program delivered in the traditional in-person format.

Standard Delivery Format

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• informal (unpaid) caregivers for an adult with a chronic condition
• speak English
• cognitive ability to participate in PTC classes
• for the telehealth delivered classes have a home internet connection, computer with a camera and microphone, and demonstrate the cognitive ability to use a computer and participate in the program

You may not qualify if:

• non-English speaking (the PTC program and materials will be delivered in English; participants will need to be proficient in English to engage with the other members of the class)

Sponsors & Collaborators

• Concordia University Wisconsin: lead

Study Sites (13)

OPICA Adult Day Program

Los Angeles, California, 90025, United States

Location

Health Projects Center

Santa Cruz, California, 95060, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Southeast Idaho Council of Governments Inc

Pocatello, Idaho, 83201, United States

Location

Iowa State University (ISU) Extension and Outreach

Webster City, Iowa, 50248, United States

Location

Michigan State University

Grand Rapids, Michigan, 49503, United States

Location

Lutheran Social Service

Moorhead, Minnesota, 56560, United States

Location

Executive Services Corps - NE

Plattsmouth, Nebraska, 68048, United States

Location

Concord Regional Visiting Nurse Association (VNA)

Concord, New Hampshire, 03301, United States

Location

Kettering Health Network

Beavercreek, Ohio, 45431, United States

Location

Hope Grows and UPMC Health Plan

Pittsburgh, Pennsylvania, 15108, United States

Location

Jane Joyce

Morristown, Tennessee, 37814, United States

Location

Central East Local Health Integration Network

Whitby, Ontario, L1N 6K9, Canada

Location

Related Publications (14)

• American Occupational Therapy Association. (2013). Telehealth [Position paper]. American Journal of Occupational Therapy, 67(6, Suppl.), S69-S90. https://doi.org/10.5014/ajot.2013.67S69

  BACKGROUND

• Bakas T, Champion V, Perkins SM, Farran CJ, Williams LS. Psychometric testing of the revised 15-item Bakas Caregiving Outcomes Scale. Nurs Res. 2006 Sep-Oct;55(5):346-55. doi: 10.1097/00006199-200609000-00007.

  PMID: 16980835 BACKGROUND

• Boise, L., Congleton, L., & Shannon, K. (2005). Empowering family caregivers: The powerful tools for caregiving program. Educational Gerontology, 31, 573-586. https://doi.org/10.1080/03601270590962523

  BACKGROUND

• Burton LC, Zdaniuk B, Schulz R, Jackson S, Hirsch C. Transitions in spousal caregiving. Gerontologist. 2003 Apr;43(2):230-41. doi: 10.1093/geront/43.2.230.

  PMID: 12677080 BACKGROUND

• Cohn ER, Brannon JA, Cason J. Resolving barriers to licensure portability for telerehabilitation professionals. Int J Telerehabil. 2011 Dec 20;3(2):31-4. doi: 10.5195/ijt.2011.6078. eCollection 2011 Fall. No abstract available.

  PMID: 25945189 BACKGROUND

• Eaton, W. W., Smith, C., Ybarra, M., Muntaner, C., & Tien, A. (2004). Center of Epidemiologic Studies Depression Scale: Review and revision (CESD and CESD-R). In M.E. Maruish (Ed.), The use of psychological testing for treatment planning and outcomes assessment (3rd ed.) (pp. 363-377). Mahwah, NJ: Lawrence Erlbaum.

  BACKGROUND

• National Alliance for Caregiving, & American Associate of Retired Persons Public Policy Institute. (2015, June). Executive summary: Caregiving in the U.S. Retrieved from http://www.caregiving.org/wp-content/uploads/2015/05/2015_CaregivingintheUS_Executive-Summary-June-4_WEB.pdf

  BACKGROUND

• Reinhard, S. C., Feinberg, L. F., Choula, R. & Houser, A. (2015). Valuing the invaluable: 2015 update, undeniable progress, but big gaps remain (AARP Public Policy Institute Report). Retrieved from http://www.aarp.org/content/dam/aarp/ppi/2015/valuing-the-invaluable-2015-update-new.pdf

  BACKGROUND

• Savundranayagam MY, Montgomery RJ, Kosloski K, Little TD. Impact of a psychoeducational program on three types of caregiver burden among spouses. Int J Geriatr Psychiatry. 2011 Apr;26(4):388-96. doi: 10.1002/gps.2538.

  PMID: 20652873 BACKGROUND

• Serwe KM, Hersch GI, Pancheri K. Feasibility of Using Telehealth to Deliver the "Powerful Tools for Caregivers" Program. Int J Telerehabil. 2017 Jun 29;9(1):15-22. doi: 10.5195/ijt.2017.6214. eCollection 2017 Spring.

  PMID: 28814991 BACKGROUND

• Serwe KM, Hersch GI, Pickens ND, Pancheri K. Caregiver Perceptions of a Telehealth Wellness Program. Am J Occup Ther. 2017 Jul/Aug;71(4):7104350010p1-7104350010p5. doi: 10.5014/ajot.2017.025619.

  PMID: 28661387 BACKGROUND

• VSee. (2018). HIPAA and VSee video conferencing. Retrieved from https://vsee.com/hipaa/

  BACKGROUND

• Won CW, Fitts SS, Favaro S, Olsen P, Phelan EA. Community-based "powerful tools" intervention enhances health of caregivers. Arch Gerontol Geriatr. 2008 Jan-Feb;46(1):89-100. doi: 10.1016/j.archger.2007.02.009. Epub 2007 Apr 27.

  PMID: 17467080 BACKGROUND

• Serwe KM, Walmsley AL. The effectiveness of telehealth for a caregiver wellness program. J Telemed Telecare. 2023 Aug;29(7):504-512. doi: 10.1177/1357633X21994009. Epub 2021 Jul 7.

  PMID: 34233538 DERIVED

Study Officials

• Katrina M Serwe, PhD

  Concordia University Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data will be collected via survey and data analysis will be conducted blinded to study group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 11, 2019
• Study Start: February 1, 2019
• Primary Completion: October 8, 2020
• Study Completion: October 8, 2020
• Last Updated: October 29, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (12); CA (1)