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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04428034
Other study ID # HSC20200410H
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 3, 2020
Est. completion date September 9, 2021

Study information

Verified date March 2023
Source The University of Texas Health Science Center at San Antonio
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date September 9, 2021
Est. primary completion date August 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Learning Skills Together
Information provided in arm/group description.

Locations

Country Name City State
United States UT Health San Antonio San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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

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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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