<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03800238</url>
  </required_header>
  <id_info>
    <org_study_id>ConcordiaUW</org_study_id>
    <nct_id>NCT03800238</nct_id>
  </id_info>
  <brief_title>Telehealth Powerful Tools for Caregivers Effectiveness Study</brief_title>
  <acronym>TPTC</acronym>
  <official_title>Telehealth Powerful Tools for Caregivers Effectiveness Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Concordia University Wisconsin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Concordia University Wisconsin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to examine the efficacy of telehealth as a delivery format&#xD;
      for an education-based caregiver wellness program focusing on self-care. The study will&#xD;
      examine two research questions. 1) Are outcomes equivalent for caregivers in an education&#xD;
      based-wellness program delivered via telehealth and one delivered in person as measured by a&#xD;
      general rating of health, the Center for Epidemiologic Studies Depression Scale - Revised&#xD;
      (CESD-R), self-care behaviors (health self-care neglect, frequency of stress management and&#xD;
      relaxation activities, and exercise frequency), self-efficacy, use of community resources,&#xD;
      and the Bakas Caregiving Outcomes Scale (BCOS)? 2) Is class attendance equivalent for classes&#xD;
      delivered via telehealth and in person? This research involves a specific education-based&#xD;
      caregiver wellness program called Powerful Tools for Caregivers (PTC). PTC is an&#xD;
      evidence-based six-week program that addresses caregiver health by promoting self-care.&#xD;
      Collaborating community organizations offer the program at little to no cost.&#xD;
&#xD;
      This study will employ a quasi-experimental nonequivalent pretest-posttest design to compare&#xD;
      outcomes from in-person to telehealth delivered PTC classes. PTC classes are conducted by a&#xD;
      pair of class leaders who model concepts. Each pair of class leaders will conduct both a&#xD;
      telehealth and in-person PTC class. Collaborating community organizations will recruit 105&#xD;
      caregivers to attend PTC classes delivered by 7 pairs of class leaders.&#xD;
&#xD;
      Telehealth classes will use VSee software to allow caregivers to participate in the PTC&#xD;
      program synchronously via secure videoconferencing from their own home. VSee is a free&#xD;
      software program designed to deliver secure telehealth services. Class leaders will guide&#xD;
      participants in installation of the software on their home computer.&#xD;
&#xD;
      Participants will undergo assessment one week before and one week after the PTC program, and&#xD;
      at six-month follow up. Outcome measures replicate previous PTC research and add additional&#xD;
      outcomes meaningful to caregiver wellness. Statistical analysis will include descriptive&#xD;
      statistics and a mixed design analysis of variance including repeated measures to examine&#xD;
      differences in the variables of interest over time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose&#xD;
&#xD;
      An estimated 43.5 million Americans serve as an unpaid caregiver over the course of a year.&#xD;
      Caregivers are a valuable part of healthcare systems, providing a framework for the medical&#xD;
      system to work in the home. Caregivers assist in patient follow through with medical advice,&#xD;
      transportation to medical appointments, activation of emergency medical services, and&#xD;
      promotion of patient quality of life. Caregivers are an asset to the healthcare system, as&#xD;
      they reduce overall healthcare costs; in 2013, unpaid care was estimated at 470 billion&#xD;
      dollars a year in the United States. Unfortunately, caregivers are at risk for both physical&#xD;
      and mental health problems. In-person programs do exist that are designed to help caregivers&#xD;
      care for themselves and mitigate their increased health risks. However, many caregivers are&#xD;
      unable to attend such programs.&#xD;
&#xD;
      Caregivers face barriers to accessing wellness programming due to lack of time, distance from&#xD;
      service delivery locations, availability of services, and health or caregiving demands&#xD;
      limiting the ability to leave home. Telehealth offers a solution to many of the barriers&#xD;
      caregivers report. Telehealth is the use of technology to deliver healthcare services at a&#xD;
      distance. Telehealth allows people access to services regardless of physical location,&#xD;
      availability of transportation, and availability of respite care. Telehealth also reduces&#xD;
      travel related costs for both providers and clients. While telehealth may provide a solution&#xD;
      to increase access to services for those who face barriers to in-person services, there is&#xD;
      limited information on the efficacy of telehealth delivered services. No studies have been&#xD;
      reported that directly compare outcomes from telehealth and in-person wellness programs for&#xD;
      caregivers.&#xD;
&#xD;
      This research will fill a needed gap to inform service delivery decision making related to&#xD;
      telehealth delivered programming for caregivers. Consequently, the overall goal of this&#xD;
      proposed research is to determine the efficacy of translating the PTC program to a telehealth&#xD;
      delivery format. The specific objectives are: 1) To determine whether the outcomes are&#xD;
      different for caregivers in a PTC program delivered via telehealth compared to one delivered&#xD;
      in person. 2) To examine program attendance and reasons for missed sessions.&#xD;
&#xD;
      These objectives will be addressed by examining the following outcomes: 1) a general rating&#xD;
      of health, 2) the Center for Epidemiologic Studies Depression Scale - Revised (CESD-R), 3)&#xD;
      self-care behaviors (health self-care neglect, frequency of stress management and relaxation&#xD;
      activities, and exercise frequency), self-efficacy, use of community resources, 4) the&#xD;
      overall caregiving experience as measured by the Bakas Caregiving Outcomes Scale (BCOS), and&#xD;
      5) class attendance including reasons for missed classes.&#xD;
&#xD;
      The existing program that this study proposes to examine is Powerful Tools for Caregivers,&#xD;
      which has demonstrated positive outcomes for caregivers when delivered in-person. These&#xD;
      benefits include reduced health risk behaviors; increased frequency in participation in&#xD;
      self-care activities such as relaxation, exercise, and use of stress management techniques;&#xD;
      demonstrate increased self-efficacy; lower stress levels; and report decreased caregiver&#xD;
      burden. If the telehealth delivery method is proven effective by this research, more&#xD;
      caregivers will be able to receive these benefits, thereby promoting positive health&#xD;
      behaviors that prevent physical and mental health problems in this at-risk population.&#xD;
&#xD;
      PTC is an evidence-based six-week program that addresses caregiver health by promoting&#xD;
      self-care. Collaborating community organizations offer the program at little to no cost. A&#xD;
      preliminary feasibility study was done to prepare for the proposed research. The feasibility&#xD;
      study involved four caregivers. Consistent class attendance and Telehealth Usability&#xD;
      Questionnaire scores demonstrated the telehealth delivery format was feasible, and&#xD;
      qualitative themes indicated caregivers had a positive experience. A pilot study was then&#xD;
      conducted involving 18 caregivers in four PTC groups in four different states and examined&#xD;
      both caregiver outcomes and the class leader experience of delivering PTC via telehealth.&#xD;
      Results have informed the design of this proposed study.&#xD;
&#xD;
      Methodology&#xD;
&#xD;
      The proposed study is a collaboration between the National PTC Office, collaborating&#xD;
      community agencies, and the principal investigator (PI) at Concordia University Wisconsin&#xD;
      (CUW). The National PTC Office will provide supervision to assure fidelity to the PTC&#xD;
      program. The National PTC Office will assist with recruiting existing PTC Class Leaders who&#xD;
      are certified Master Trainers (those who are both certified PTC class leaders and certified&#xD;
      to train other class leaders) to conduct PTC classes. PTC class leaders will be selected&#xD;
      through an application process to meet criteria for experience in leading classes and to&#xD;
      represent a diverse geographical region. These class leaders will undergo human subjects&#xD;
      research training and work with the PI to assure compliance with the research protocol.&#xD;
&#xD;
      The proposed study will employ a quasi-experimental nonequivalent pretest-posttest design to&#xD;
      compare outcomes from in-person to telehealth delivered PTC classes. PTC classes are&#xD;
      conducted by a pair of class leaders who model concepts. Each pair of class leaders will&#xD;
      conduct both a telehealth and in-person PTC class. This will control for the influence of&#xD;
      class leader personality on outcomes.&#xD;
&#xD;
      Collaborating community organizations will recruit 105 caregivers to attend PTC classes&#xD;
      delivered by seven pairs of class leaders. Class sizes will be unequal due to necessity.&#xD;
      Traditional in-person PTC programs are delivered to groups of 10 caregivers. Telehealth&#xD;
      classes are limited to five participants due to limitations in screen views and internet&#xD;
      bandwidth. Class leaders require a video screen, as do each participant. It is distracting to&#xD;
      view more than six video screens at once; furthermore, adding more than six participants&#xD;
      degrades the video and audio quality due to limitations in home internet connection&#xD;
      bandwidths. The in-person classes include partner discussions. Telehealth technology does not&#xD;
      allow private partner discussions; however, the smaller group format is conducive to full&#xD;
      group conversations for these aspects of the program. To control for the effect of class&#xD;
      leaders' personality, class leaders will deliver one telehealth PTC program and one in-person&#xD;
      PTC program. This creates unequal group sizes of 35 participants in the telehealth PTC group&#xD;
      and 70 participants in the in-person PTC group.&#xD;
&#xD;
      The sample of 105 caregivers was determined based on a power analysis calculated using G&#xD;
      Power software and effect sizes and attrition rates from the pilot study data. In the pilot&#xD;
      study the CESD-R had a large effect size, while the BCOS and the other health and self-care&#xD;
      related variables on the survey had medium to small effect sizes. The PI selected the BCOS&#xD;
      with a Cohen's d = 0.26 for the power analysis, an alpha error probability of 0.05, and power&#xD;
      of 0.80 to calculate sample size using G Power software. The result was a recommended sample&#xD;
      size of 82 participants. The pilot study had a 33% rate of attrition. Planning for this level&#xD;
      of drop out at posttest and another 33% at 6-months required an additional 15 participants be&#xD;
      added to the sample size for a total of 97 participants in each group.&#xD;
&#xD;
      Participants will be recruited through the partnering community organizations of the PTC&#xD;
      class leaders. Participants will be informal (unpaid) caregivers, speak English, have the&#xD;
      cognitive ability to participate in PTC classes, and for the telehealth delivered classes&#xD;
      have a home internet connection, computer with a camera and microphone, and demonstrate the&#xD;
      cognitive ability to use a computer and participate in the program. PTC class leaders will&#xD;
      screen participants to be sure they meet eligibility criteria.&#xD;
&#xD;
      Telehealth classes will use VSee software to allow caregivers to participate in the PTC&#xD;
      program synchronously via secure videoconferencing from their own home. VSee is a free&#xD;
      software program designed to deliver secure telehealth services. Class leaders will guide&#xD;
      participants in installation of the software on their home computer. The telehealth process&#xD;
      was developed and tested in earlier phases of this research.&#xD;
&#xD;
      Participants will undergo assessment one week before and one week after the PTC program, and&#xD;
      at a six-month follow up. Outcome measures replicate previous PTC research and offer&#xD;
      additional outcome measures meaningful to caregiver wellness. Assessments include: the Center&#xD;
      for Epidemiologic Studies Depression Scale - Revised (CESD-R), the Bakas Caregiving Outcomes&#xD;
      Scale (BCOS), and a PTC Taking Care of You Survey which includes items from the original PTC&#xD;
      program outcomes research related to caregiver self-efficacy, health self-care neglect,&#xD;
      exercise frequency, relaxation frequency, and service utilization. The survey will also&#xD;
      include caregiver demographics and questions related to socialization. The CESD-R is an&#xD;
      established tool to assess symptoms of depression and the BCOS captures both positive and&#xD;
      negative aspects of the caregiver experience. Both tools have established reliability and&#xD;
      validity. The three assessment tools will be delivered via one secure electronic survey link&#xD;
      issued by the PI. PTC class leaders will record attendance and reasons for any missed&#xD;
      classes.&#xD;
&#xD;
      Data Analysis&#xD;
&#xD;
      Microsoft Excel and SPSS version 25 software will be used for statistical analysis.&#xD;
      Statistical analysis will include descriptive statistics, and a mixed design or split plot&#xD;
      analysis of variance (ANOVA), which includes repeated measures, to examine differences in the&#xD;
      variables of interest over time: CESD-R score, BCOS score, class attendance, caregiver&#xD;
      self-efficacy, health self-care neglect, exercise frequency, relaxation frequency, frequency&#xD;
      of service utilization, and frequency of socialization. Groups (telehealth delivered group n&#xD;
      = 35 and in-person delivery model n = 70) will be analyzed for differences prior to running&#xD;
      ANOVA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">October 8, 2020</completion_date>
  <primary_completion_date type="Actual">October 8, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Data will be collected via survey and data analysis will be conducted blinded to study group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Center for Epidemiologic Studies Depression Scale - Revised (CESD-R)</measure>
    <time_frame>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.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bakas Caregiving Outcomes Scale (BCOS)</measure>
    <time_frame>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.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Custom created questionnaire: PTC Taking Care of You Survey</measure>
    <time_frame>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.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">115</enrollment>
  <condition>Caregivers</condition>
  <arm_group>
    <arm_group_label>Telehealth Delivery Format</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will participate in the Powerful Tools for Caregivers program using a telehealth delivery method.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Delivery Format</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will participate in the Powerful Tools for Caregivers program in person.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telehealth Delivery Format</intervention_name>
    <description>Participants will engage in a 6-week Powerful Tools for Caregivers program delivered via telehealth.</description>
    <arm_group_label>Telehealth Delivery Format</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Delivery Format</intervention_name>
    <description>Participants will engage in a 6-week Powerful Tools for Caregivers program delivered in the traditional in-person format.</description>
    <arm_group_label>Standard Delivery Format</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  informal (unpaid) caregivers for an adult with a chronic condition&#xD;
&#xD;
          -  speak English&#xD;
&#xD;
          -  cognitive ability to participate in PTC classes&#xD;
&#xD;
          -  for the telehealth delivered classes have a home internet connection, computer with a&#xD;
             camera and microphone, and demonstrate the cognitive ability to use a computer and&#xD;
             participate in the program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • non-English speaking (the PTC program and materials will be delivered in English;&#xD;
        participants will need to be proficient in English to engage with the other members of the&#xD;
        class)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katrina M Serwe, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Concordia University Wisconsin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OPICA Adult Day Program</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Projects Center</name>
      <address>
        <city>Santa Cruz</city>
        <state>California</state>
        <zip>95060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeast Idaho Council of Governments Inc</name>
      <address>
        <city>Pocatello</city>
        <state>Idaho</state>
        <zip>83201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa State University (ISU) Extension and Outreach</name>
      <address>
        <city>Webster City</city>
        <state>Iowa</state>
        <zip>50248</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan State University</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lutheran Social Service</name>
      <address>
        <city>Moorhead</city>
        <state>Minnesota</state>
        <zip>56560</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Executive Services Corps - NE</name>
      <address>
        <city>Plattsmouth</city>
        <state>Nebraska</state>
        <zip>68048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Concord Regional Visiting Nurse Association (VNA)</name>
      <address>
        <city>Concord</city>
        <state>New Hampshire</state>
        <zip>03301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kettering Health Network</name>
      <address>
        <city>Beavercreek</city>
        <state>Ohio</state>
        <zip>45431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hope Grows and UPMC Health Plan</name>
      <address>
        <city>Allegheny</city>
        <state>Pennsylvania</state>
        <zip>15108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jane Joyce</name>
      <address>
        <city>Morristown</city>
        <state>Tennessee</state>
        <zip>37814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central East Local Health Integration Network</name>
      <address>
        <city>Whitby</city>
        <state>Ontario</state>
        <zip>L1N 6K9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16980835</PMID>
  </reference>
  <reference>
    <citation>Boise, L., Congleton, L., &amp; Shannon, K. (2005). Empowering family caregivers: The powerful tools for caregiving program. Educational Gerontology, 31, 573-586. https://doi.org/10.1080/03601270590962523</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>12677080</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25945189</PMID>
  </reference>
  <reference>
    <citation>Eaton, W. W., Smith, C., Ybarra, M., Muntaner, C., &amp; 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.</citation>
  </reference>
  <reference>
    <citation>National Alliance for Caregiving, &amp; 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</citation>
  </reference>
  <reference>
    <citation>Reinhard, S. C., Feinberg, L. F., Choula, R. &amp; 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</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20652873</PMID>
  </reference>
  <reference>
    <citation>Serwe KM, Hersch GI, Pancheri K. Feasibility of Using Telehealth to Deliver the &quot;Powerful Tools for Caregivers&quot; Program. Int J Telerehabil. 2017 Jun 29;9(1):15-22. doi: 10.5195/ijt.2017.6214. eCollection 2017 Spring.</citation>
    <PMID>28814991</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>28661387</PMID>
  </reference>
  <reference>
    <citation>VSee. (2018). HIPAA and VSee video conferencing. Retrieved from https://vsee.com/hipaa/</citation>
  </reference>
  <reference>
    <citation>Won CW, Fitts SS, Favaro S, Olsen P, Phelan EA. Community-based &quot;powerful tools&quot; 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.</citation>
    <PMID>17467080</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>October 28, 2020</last_update_submitted>
  <last_update_submitted_qc>October 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Concordia University Wisconsin</investigator_affiliation>
    <investigator_full_name>Katrina Serwe</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>caregiver</keyword>
  <keyword>wellness</keyword>
  <keyword>telehealth</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03800238
org study id: ConcordiaUW
nct id: NCT03800238
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
Purpose

      An estimated 43.5 million Americans serve as an unpaid caregiver over the course of a year.
      Caregivers are a valuable part of healthcare systems, providing a framework for the medical
      system to work in the home. Caregivers assist in patient follow through with medical advice,
      transportation to medical appointments, activation of emergency medical services, and
      promotion of patient quality of life. Caregivers are an asset to the healthcare system, as
      they reduce overall healthcare costs; in 2013, unpaid care was estimated at 470 billion
      dollars a year in the United States. Unfortunately, caregivers are at risk for both physical
      and mental health problems. In-person programs do exist that are designed to help caregivers
      care for themselves and mitigate their increased health risks. However, many caregivers are
      unable to attend such programs.

      Caregivers face barriers to accessing wellness programming due to lack of time, distance from
      service delivery locations, availability of services, and health or caregiving demands
      limiting the ability to leave home. Telehealth offers a solution to many of the barriers
      caregivers report. Telehealth is the use of technology to deliver healthcare services at a
      distance. Telehealth allows people access to services regardless of physical location,
      availability of transportation, and availability of respite care. Telehealth also reduces
      travel related costs for both providers and clients. While telehealth may provide a solution
      to increase access to services for those who face barriers to in-person services, there is
      limited information on the efficacy of telehealth delivered services. No studies have been
      reported that directly compare outcomes from telehealth and in-person wellness programs for
      caregivers.

      This research will fill a needed gap to inform service delivery decision making related to
      telehealth delivered programming for caregivers. Consequently, the overall goal of this
      proposed research is to determine the efficacy of translating the PTC program to a telehealth
      delivery format. The specific objectives are: 1) To determine whether the outcomes are
      different for caregivers in a PTC program delivered via telehealth compared to one delivered
      in person. 2) To examine program attendance and reasons for missed sessions.

      These objectives will be addressed by examining the following outcomes: 1) a general rating
      of health, 2) the Center for Epidemiologic Studies Depression Scale - Revised (CESD-R), 3)
      self-care behaviors (health self-care neglect, frequency of stress management and relaxation
      activities, and exercise frequency), self-efficacy, use of community resources, 4) the
      overall caregiving experience as measured by the Bakas Caregiving Outcomes Scale (BCOS), and
      5) class attendance including reasons for missed classes.

      The existing program that this study proposes to examine is Powerful Tools for Caregivers,
      which has demonstrated positive outcomes for caregivers when delivered in-person. These
      benefits include reduced health risk behaviors; increased frequency in participation in
      self-care activities such as relaxation, exercise, and use of stress management techniques;
      demonstrate increased self-efficacy; lower stress levels; and report decreased caregiver
      burden. If the telehealth delivery method is proven effective by this research, more
      caregivers will be able to receive these benefits, thereby promoting positive health
      behaviors that prevent physical and mental health problems in this at-risk population.

      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. A
      preliminary feasibility study was done to prepare for the proposed research. The feasibility
      study involved four caregivers. Consistent class attendance and Telehealth Usability
      Questionnaire scores demonstrated the telehealth delivery format was feasible, and
      qualitative themes indicated caregivers had a positive experience. A pilot study was then
      conducted involving 18 caregivers in four PTC groups in four different states and examined
      both caregiver outcomes and the class leader experience of delivering PTC via telehealth.
      Results have informed the design of this proposed study.

      Methodology

      The proposed study is a collaboration between the National PTC Office, collaborating
      community agencies, and the principal investigator (PI) at Concordia University Wisconsin
      (CUW). The National PTC Office will provide supervision to assure fidelity to the PTC
      program. The National PTC Office will assist with recruiting existing PTC Class Leaders who
      are certified Master Trainers (those who are both certified PTC class leaders and certified
      to train other class leaders) to conduct PTC classes. PTC class leaders will be selected
      through an application process to meet criteria for experience in leading classes and to
      represent a diverse geographical region. These class leaders will undergo human subjects
      research training and work with the PI to assure compliance with the research protocol.

      The proposed 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. This will control for the influence of
      class leader personality on outcomes.

      Collaborating community organizations will recruit 105 caregivers to attend PTC classes
      delivered by seven pairs of class leaders. Class sizes will be unequal due to necessity.
      Traditional in-person PTC programs are delivered to groups of 10 caregivers. Telehealth
      classes are limited to five participants due to limitations in screen views and internet
      bandwidth. Class leaders require a video screen, as do each participant. It is distracting to
      view more than six video screens at once; furthermore, adding more than six participants
      degrades the video and audio quality due to limitations in home internet connection
      bandwidths. The in-person classes include partner discussions. Telehealth technology does not
      allow private partner discussions; however, the smaller group format is conducive to full
      group conversations for these aspects of the program. To control for the effect of class
      leaders' personality, class leaders will deliver one telehealth PTC program and one in-person
      PTC program. This creates unequal group sizes of 35 participants in the telehealth PTC group
      and 70 participants in the in-person PTC group.

      The sample of 105 caregivers was determined based on a power analysis calculated using G
      Power software and effect sizes and attrition rates from the pilot study data. In the pilot
      study the CESD-R had a large effect size, while the BCOS and the other health and self-care
      related variables on the survey had medium to small effect sizes. The PI selected the BCOS
      with a Cohen's d = 0.26 for the power analysis, an alpha error probability of 0.05, and power
      of 0.80 to calculate sample size using G Power software. The result was a recommended sample
      size of 82 participants. The pilot study had a 33% rate of attrition. Planning for this level
      of drop out at posttest and another 33% at 6-months required an additional 15 participants be
      added to the sample size for a total of 97 participants in each group.

      Participants will be recruited through the partnering community organizations of the PTC
      class leaders. Participants will be informal (unpaid) caregivers, speak English, have the
      cognitive ability to participate in PTC classes, and 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. PTC class leaders will
      screen participants to be sure they meet eligibility criteria.

      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. The telehealth process
      was developed and tested in earlier phases of this research.

      Participants will undergo assessment one week before and one week after the PTC program, and
      at a six-month follow up. Outcome measures replicate previous PTC research and offer
      additional outcome measures meaningful to caregiver wellness. Assessments include: the Center
      for Epidemiologic Studies Depression Scale - Revised (CESD-R), the Bakas Caregiving Outcomes
      Scale (BCOS), and a PTC Taking Care of You Survey which includes items from the original PTC
      program outcomes research 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. The CESD-R is an
      established tool to assess symptoms of depression and the BCOS captures both positive and
      negative aspects of the caregiver experience. Both tools have established reliability and
      validity. The three assessment tools will be delivered via one secure electronic survey link
      issued by the PI. PTC class leaders will record attendance and reasons for any missed
      classes.

      Data Analysis

      Microsoft Excel and SPSS version 25 software will be used for statistical analysis.
      Statistical analysis will include descriptive statistics, and a mixed design or split plot
      analysis of variance (ANOVA), which includes repeated measures, to examine differences in the
      variables of interest over time: CESD-R score, BCOS score, class attendance, caregiver
      self-efficacy, health self-care neglect, exercise frequency, relaxation frequency, frequency
      of service utilization, and frequency of socialization. Groups (telehealth delivered group n
      = 35 and in-person delivery model n = 70) will be analyzed for differences prior to running
      ANOVA.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Data will be collected via survey and data analysis will be conducted blinded to study group assignment.
measure: Center for Epidemiologic Studies Depression Scale - Revised (CESD-R)
time frame: 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.
description: 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.
measure: Bakas Caregiving Outcomes Scale (BCOS)
time frame: 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.
description: 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.
measure: Custom created questionnaire: PTC Taking Care of You Survey
time frame: 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.
description: 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.
arm group label: Telehealth Delivery Format
arm group type: Experimental
description: This group will participate in the Powerful Tools for Caregivers program using a telehealth delivery method.
arm group label: Standard Delivery Format
arm group type: Active Comparator
description: This group will participate in the Powerful Tools for Caregivers program in person.
intervention type: Behavioral
intervention name: Telehealth Delivery Format
description: Participants will engage in a 6-week Powerful Tools for Caregivers program delivered via telehealth.
arm group label: Telehealth Delivery Format
intervention type: Behavioral
intervention name: Standard Delivery Format
description: Participants will engage in a 6-week Powerful Tools for Caregivers program delivered in the traditional in-person format.
arm group label: Standard Delivery Format
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Katrina M Serwe, PhD
role: Principal Investigator
affiliation: Concordia University Wisconsin
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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.
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: VSee. (2018). HIPAA and VSee video conferencing. Retrieved from https://vsee.com/hipaa/
citation: 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
responsible party type: Principal Investigator
investigator affiliation: Concordia University Wisconsin
investigator full name: Katrina Serwe
investigator title: Associate Professor
sharing ipd: No