Alzheimer Disease, Caregiver Burden, Dementia, Financial Stress
Conditions
Brief summary
The intervention being tested, CONFIDENCE-AI is a refined version of the original CONFIDENCE intervention made to reduce psychological financial strain and improve management of out-of-pocket care costs while increasing caregiver resourcefulness skills. Participants will be asked to participate in a 4-week intervention that includes participation in four, synchronous group-based Zoom sessions as well as between-session activities to apply learning. Participants will also receive tailored text message notifications from the NeuViCare AI-powered app via text and will be able to submit questions to the app to receive financial well-being information related to caregiving.
Interventions
Multicomponent psychoeducational intervention focused on financial wellbeing
Sponsors
Study design
Eligibility
Inclusion criteria
* Self-identified caregiver to a person living with probable Alzheimer's disease or related dementia * Person living with dementia meets stage 4 to 6 criteria on Global Deterioration Scale according to the family caregiver * Has been at least 6 months since the care recipient began to experience dementia symptoms * Latino/Hispanic ethnicity.
Exclusion criteria
* Individuals who plan to place their family member in a nursing home in the next 3 months * Unreliable access to internet, tablet or smart phone, and email * Does not agree to participate in at least 3 of the 4 group sessions and/or register for the NeuViCare app * Unable to read and speak in English or Spanish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Financial Strain | The outcome measure will use the average change score from baseline scores until post-intervention (1 month post-baseline) and 2 months post-intervention (3-months after the baseline). | Financial strain will be measured using the 11-item Comprehensive Score for Financial Toxicity (COST) Scale. A modified version of COST demonstrates validity and reliability when tested among cancer caregivers (α=0.91; range: 0 to 44). COST items are generic enough to be applicable to caregivers to persons PLWD without further modification (e.g., I feel financially stressed). Caregivers are asked to indicate if each statement applies to them Not at all (0) to Very much (4). Higher scores indicate higher levels of financial strain. |
| Resourcefulness | The outcome measure will use the average change score from baseline scores until post-intervention (1 month post-baseline) and 2 months post-intervention (3-months after the baseline). | Resourcefulness is measured using the 28-item Caregiver Resourcefulness Scale (alpha=0.85). This scale has two factors: one focused on help-seeking and another on self-help. Caregivers are asked the frequency at which they use different strategies to manage challenges, and may respond: Not at all like me (0), Pretty much not like me (1), A little bit not like me (2), A little bit like me (3), Pretty much like much like me (4), or Very much like me (5). Items are added together to create a total score. Scores range from 0 to 140, where higher scores indicate higher levels of resourcefulness. The outcome measure will use the average change score from baseline scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Efficacy | The outcome measure will use the average change score from baseline scores until post-intervention (1 month post-baseline) and 2 months post-intervention (3-months after the baseline). | Self-efficacy is measured using the Caregiver Self-Efficacy Scale. This 8-item scale asks about multiple domains of self-efficacy (e.g., managing behavioral symptoms, accessing respite, and controlling upsetting thoughts). It demonstrates high reliability (alpha=0.89) and good test-retest reliability (0.73). Participants rate the extent to which they are Not confident at all (1) to Totally confident (10). Scores range from 8 (lowest level of self-efficacy) to 80 (highest level of self-efficacy). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CONFIDENCE AI Participants will attend the 4-week CONFIDENCE-AI Program. This program will include attending 4 group-based sessions delivered by videoconference. Each session will last approximately 1.5 hours each and will cover topics such as how to budget, accessing community resources to displace the out-of-pocket costs of caregiving, asking for help, and more. Participation will be supplemented by access to a digital app to support engagement, such as through text messaging and resources navigation support.
CONFIDENCE-AI: Multicomponent psychoeducational intervention focused on financial wellbeing | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | CONFIDENCE AI |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 54.3 years STANDARD_DEVIATION 7.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Financial Strain | 28.4 units on a scale STANDARD_DEVIATION 5.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 14 participants |
| Resourcefulness | 75.3 units on a scale STANDARD_DEVIATION 34.1 |
| Self-Efficacy | 32.0 units on a scale STANDARD_DEVIATION 16.7 |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Financial Strain
Financial strain will be measured using the 11-item Comprehensive Score for Financial Toxicity (COST) Scale. A modified version of COST demonstrates validity and reliability when tested among cancer caregivers (α=0.91; range: 0 to 44). COST items are generic enough to be applicable to caregivers to persons PLWD without further modification (e.g., I feel financially stressed). Caregivers are asked to indicate if each statement applies to them Not at all (0) to Very much (4). Higher scores indicate higher levels of financial strain.
Time frame: The outcome measure will use the average change score from baseline scores until post-intervention (1 month post-baseline) and 2 months post-intervention (3-months after the baseline).
Population: From baseline to the post-intervention data collection point, three participants were lost to follow up and one participant was missing a survey item response required to calculate this score. Thus, data is available for 10 of 14 participants.~From baseline to the 2-month post-intervention data collection point, one more case was lost to follow up and another was missing a survey item response required to calculate this score. Thus, data is available for 9 of 14 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CONFIDENCE AI | Financial Strain | Change score from baseline scores until post-intervention | -3.4 units on a scale | Standard Deviation 4.9 |
| CONFIDENCE AI | Financial Strain | Change score from baseline scores until 2-months post-intervention | -4.7 units on a scale | Standard Deviation 6.6 |
Resourcefulness
Resourcefulness is measured using the 28-item Caregiver Resourcefulness Scale (alpha=0.85). This scale has two factors: one focused on help-seeking and another on self-help. Caregivers are asked the frequency at which they use different strategies to manage challenges, and may respond: Not at all like me (0), Pretty much not like me (1), A little bit not like me (2), A little bit like me (3), Pretty much like much like me (4), or Very much like me (5). Items are added together to create a total score. Scores range from 0 to 140, where higher scores indicate higher levels of resourcefulness. The outcome measure will use the average change score from baseline scores
Time frame: The outcome measure will use the average change score from baseline scores until post-intervention (1 month post-baseline) and 2 months post-intervention (3-months after the baseline).
Population: From baseline to the post-intervention data collection point, three participants were lost to follow up and one participant was missing a survey item response required to calculate this score. Thus, data is available for 10 of 14 participants.~From baseline to the 2-month post-intervention data collection point, one more case was lost to follow up and two more cases were missing a survey item response required to calculate this score. Thus, data is available for 8 of 14 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CONFIDENCE AI | Resourcefulness | Change score from baseline scores until post-intervention | 13.2 score on a scale | Standard Deviation 25.7 |
| CONFIDENCE AI | Resourcefulness | Change score from baseline scores until 2-months post-intervention | 11.3 score on a scale | Standard Deviation 13.3 |
Self-Efficacy
Self-efficacy is measured using the Caregiver Self-Efficacy Scale. This 8-item scale asks about multiple domains of self-efficacy (e.g., managing behavioral symptoms, accessing respite, and controlling upsetting thoughts). It demonstrates high reliability (alpha=0.89) and good test-retest reliability (0.73). Participants rate the extent to which they are Not confident at all (1) to Totally confident (10). Scores range from 8 (lowest level of self-efficacy) to 80 (highest level of self-efficacy).
Time frame: The outcome measure will use the average change score from baseline scores until post-intervention (1 month post-baseline) and 2 months post-intervention (3-months after the baseline).
Population: From baseline to the post-intervention data collection point, three participants were lost to follow up. Thus, data is available for 10 of 14 participants.~From baseline to the 2-month post-intervention data collection point, one more case was lost to follow up and another was missing a survey item response required to calculate this score. Thus, data is available for 9 of 14 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CONFIDENCE AI | Self-Efficacy | Change score from baseline scores until post-intervention | 16.3 units on a scale | Standard Deviation 15.2 |
| CONFIDENCE AI | Self-Efficacy | Change score from baseline scores until 2-months post-intervention | 13.2 units on a scale | Standard Deviation 10.3 |