An interventional study of Learning Skills Together in Family Caregiving, Complex Care and Self Efficacy, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-21.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Other
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.
The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: Change from baseline to 4 weeks post-intervention; and to 8 weeks post-intervention
| Milestone | Learning Skills Together Intervention |
|---|---|
| Started | 41 |
| Attended at least 2 intervention sessions in one cohort | 35 |
| Completed | 35 |
| Not completed | 6 |
| Withdrew: Protocol violation | 6 |
| Milestone | Learning Skills Together Intervention |
|---|---|
| Started | 35 |
| Completed | 29 |
| Not completed | 6 |
| Milestone | Learning Skills Together Intervention |
|---|---|
| Started | 29 |
| Completed | 27 |
| Not completed | 2 |
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.
| score on a scale | Learning Skills Together Intervention |
|---|---|
| 4-Weeks Post-Intervention | 1.0 ± 1.6 |
| 8-Weeks Post-Intervention | 1.0 ± 2.2 |
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.
| score on a scale | Learning Skills Together Intervention |
|---|---|
| 4-Weeks Post-Intervention | 0.7 ± 2.3 |
| 8-Weeks Post-Intervention | 0.5 ± 2.9 |
Collected over Adverse event data were collected over 1 year.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Learning Skills Together Intervention | 1/35 (2.9%) | 0/35 (0%) | 3/35 (8.6%) |
| Event | Learning Skills Together Intervention |
|---|---|
| Adverse Event: Identification of Severe DepressionPsychiatric disorders | 3/35 |
Baseline characteristics are described for the analysis population, which includes participants who were eligible according to initial criteria, but who also: 1) attended at least 2 program sessions and 2) completed the program in the same cohort (i.e., did not start in one cohort and complete "make up" sessions in the following cohort.
| Age, Categorical(Participants) | Learning Skills Together Intervention |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 18 |
| >=65 years | 17 |
| Sex: Female, Male(Participants) | Learning Skills Together Intervention |
|---|---|
| Female | 29 |
| Male | 6 |
| Race/Ethnicity, Customized(Participants) | Learning Skills Together Intervention |
|---|---|
| Race and Ethnicity — African American/Black | 3 |
| Race and Ethnicity — Asian | 3 |
| Race and Ethnicity — Caucasian/white | 19 |
| Race and Ethnicity — Hispanic | 10 |
| Region of Enrollment(participants) | Learning Skills Together Intervention |
|---|---|
| United States | 35 |
| Caregiver Competency(units on a scale) | Learning Skills Together Intervention |
|---|---|
| Mean | 11.6 ± 2.6 |
| Caregiver Mastery(units on a scale) | Learning Skills Together Intervention |
|---|---|
| Mean | 16.6 ± 2.8 |
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Plan to share: No — De-identified study data will be made available to other researchers if requested.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio