We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Learning Skills Together Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04428034
Recruitment Status : Completed
First Posted : June 11, 2020
Results First Posted : March 4, 2022
Last Update Posted : March 21, 2023
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The Learning Skills Together (LST) program is a synchronous web-based educational intervention developed to address the essential need for training to equip family caregivers to someone with mid-stage Alzheimer's disease to confidently provide complex care tasks.The purpose of this pilot study is to evaluate the feasibility of delivering LST, the program's acceptability to caregivers, and likelihood of effecting caregivers self-efficacy and mastery.

Condition or disease Intervention/treatment Phase
Family Caregiving Complex Care Self Efficacy Intervention Behavioral: Learning Skills Together Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A pre- and post-test design to test the Learning Skills Together program will be employed.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Pilot Evaluation of Learning Skills Together: A Intervention to Teach Complex Care Skills to Caregivers of Persons Living With Alzheimer's Disease
Actual Study Start Date : September 3, 2020
Actual Primary Completion Date : August 15, 2021
Actual Study Completion Date : September 9, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Learning Skills Together Intervention
Participants in the Learning Skills Together program will begin their participation with a one-on-one phone call with an interventionist, who will ensure the participant is prepared to to attend the group sessions (e.g., familiar with videoconference technology) and will help the participant to set individual goals. The caregiver participant will then attend 4, group-based sessions lasting approximately 1.5 hours each, to learn about common complex care tasks managed by family caregivers to someone with mid-stage Alzheimer's disease, such as managing behavioral symptoms of dementia, incontinence, nutrition, transferring, medication management, and more. Sessions will integrate interactive activities, such as videos, case studies, and discussions. Approximately four weeks later, caregivers will be asked to attend a group reflection session to discuss application of what was learned and progress in meeting individual goals.
 Behavioral: Learning Skills Together
Information provided in arm/group description.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in Caregiver Competency [ Time Frame: Change from baseline to 4 weeks post-intervention; and to 8 weeks post-intervention ]
    This will be measured using the Caregiving Competence Scale. This measure includes 3-items pertaining to caregiver's confidence (e.g., "I feel confident that I am meeting the needs of my relative"). There are five response options to each statement ("Strongly Disagree" [1] to "Strongly Agree" [5]), such that scores may range from 3 to 15. A lower score indicates a lower level of confidence that the caregiver is meeting their relative's needs (i.e., higher scores are better). The outcome measure will use the average change score from baseline scores.

  2. Change in Caregiver Mastery [ Time Frame: Change from baseline to 4 weeks post-intervention; and to 8 weeks post-intervention ]
    This will be measured using the Caregiver Mastery Scale. This 7-item scale asks participants the extent to which they feel they have control over various parts of their lives (e.g., "I have little control over the things that happen to me"). Participants may respond that they "Strongly Disagree (1) to Strongly agree (4) with each statement, such that scores range from 7 to 28. The lower the score, the less control the caregiver feels that they have control (i.e., higher scores are better). The mean score for this measure among caregivers to frail older adults was previously reported as 19.42 (SD 3.29), with Cronbach's alpha of 0.78. The outcome measure will use the average change score from baseline scores.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All genders are eligible. Gender is self-reported. Participants may select "Male," "Female," and "Other" gender, and may select all responses that apply.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Family member (including families of choice) to an individual living with Alzheimer's disease who has received a diagnosis from a physician
  • Ages 18 and old
  • Provides assistance with at least two instrumental activities of daily living or one activity of daily living
  • Care recipient is described as being within mid-stage Alzheimer's Disease
  • There are no plans to place the care recipient in a skilled nursing facility within the next 3 months

Exclusion Criteria:

  • The caregiver is paid to provide care
  • The caregiver does not have reliable access to a computer and internet
  • The caregiver is unable to read and speak English
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04428034


Locations
Layout table for location information
United States, Texas
UT Health San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Layout table for investigator information
Principal Investigator: Carole L White, PhD, RN UT Health San Antonio
  Study Documents (Full-Text)

Documents provided by The University of Texas Health Science Center at San Antonio:
Study Protocol and Statistical Analysis Plan  [PDF] June 3, 2020

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
Robertson, SM, Zarit, SH, Duncan, LG, Rovine, MJ, & Femia, EE. Family caregivers' patterns of positive and negative affect. Family Relations. 2007; 56(1): 12-23.

Layout table for additonal information
Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT04428034    
Other Study ID Numbers: HSC20200410H
First Posted: June 11, 2020    Key Record Dates
Results First Posted: March 4, 2022
Last Update Posted: March 21, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-identified study data will be made available to other researchers if requested.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No