Learning Skills Together Pilot Study

NCT04428034 | Completed Results

• 1 other identifier: HSC20200410H
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Family Caregiving; Complex Care; Self Efficacy; Intervention

Outcome Measures

Primary Outcomes (2)

• Change in Caregiver Competency

  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.

  Change from baseline to 4 weeks post-intervention; and to 8 weeks post-intervention

• Change in Caregiver Mastery

  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.

  Change from baseline to 4 weeks post-intervention; and to 8 weeks post-intervention

Study Arms (1)

Learning Skills Together Intervention

EXPERIMENTAL

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

Interventions

Learning Skills Together BEHAVIORAL

Information provided in arm/group description.

Learning Skills Together Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All genders are eligible. Gender is self-reported. Participants may select "Male," "Female," and "Other" gender, and may select all responses that apply.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (4)

• Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available.

  PMID: 649936 BACKGROUND

• Pearlin LI, Mullan JT, Semple SJ, Skaff MM. Caregiving and the stress process: an overview of concepts and their measures. Gerontologist. 1990 Oct;30(5):583-94. doi: 10.1093/geront/30.5.583.

  PMID: 2276631 BACKGROUND

• Chan EY, Glass G, Chua KC, Ali N, Lim WS. Relationship between Mastery and Caregiving Competence in Protecting against Burden, Anxiety and Depression among Caregivers of Frail Older Adults. J Nutr Health Aging. 2018;22(10):1238-1245. doi: 10.1007/s12603-018-1098-1.

  PMID: 30498832 BACKGROUND

• 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.

  BACKGROUND

Limitations and Caveats

Application of a. pre- and post-test design means that changes in self-efficacy cannot be attributed to the intervention alone Results from this study are subject to selection bias given participant dropout between survey collection times The small size of the analytic sample may have contributed to Type II error for some outcomes

Results Point of Contact

• Title: Kylie Meyer, PhD
• Organization: UT Health San Antonio

meyerk1@uthscsa.edu

210-450-5386

Study Officials

• Carole L White, PhD, RN

  UT Health San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pre- and post-test design to test the Learning Skills Together program will be employed.

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: September 3, 2020
• Primary Completion: August 15, 2021
• Study Completion: September 9, 2021
• Last Updated: March 21, 2023
• Results First Posted: March 4, 2022

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)