Complex Care, Family Caregiving, Intervention, Self Efficacy
Conditions
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.
Interventions
BEHAVIORALLearning Skills Together
Information provided in arm/group description.
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
A pre- and post-test design to test the Learning Skills Together program will be employed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Caregiver Competency | 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. |
| Change in Caregiver Mastery | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Learning Skills Together: Information provided in arm/group description. | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Enrollment to Intervention Completion | Protocol Violation | 6 |
Baseline characteristics
| Characteristic | Learning Skills Together Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Caregiver Competency | 11.6 units on a scale STANDARD_DEVIATION 2.6 |
| Caregiver Mastery | 16.6 units on a scale STANDARD_DEVIATION 2.8 |
| Race/Ethnicity, Customized Race and Ethnicity African American/Black | 3 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Asian | 3 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Caucasian/white | 19 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Hispanic | 10 Participants |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 35 |
| other Total, other adverse events | 3 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
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.
Time frame: Change from baseline to 4 weeks post-intervention; and to 8 weeks post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Learning Skills Together Intervention | Change in Caregiver Competency | 4-Weeks Post-Intervention | 1.0 score on a scale | Standard Deviation 1.6 |
| Learning Skills Together Intervention | Change in Caregiver Competency | 8-Weeks Post-Intervention | 1.0 score on a scale | Standard Deviation 2.2 |
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.
Time frame: Change from baseline to 4 weeks post-intervention; and to 8 weeks post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Learning Skills Together Intervention | Change in Caregiver Mastery | 4-Weeks Post-Intervention | 0.7 score on a scale | Standard Deviation 2.3 |
| Learning Skills Together Intervention | Change in Caregiver Mastery | 8-Weeks Post-Intervention | 0.5 score on a scale | Standard Deviation 2.9 |