Health Related Social Needs (HRSN)
Conditions
Keywords
caregivers, dementia, information-sharing, Alzheimer's Disease, caregiving, community resources
Brief summary
Caregivers of home-dwelling people with Alzheimer's Disease and related dementias (ADRD) are one of the most rapidly growing populations in the United States. Among ADRD caregivers with unmet health-related social needs, this study aims to evaluate the effects of the CRx-D intervention versus usual care on caregiver self-efficacy.
Detailed description
The CRx-D intervention is a caregiver-centered adaptation of CommunityRx (CRx), an information-based intervention that systematically matches people to nearby community resources for health-related social needs. We are conducting a single-blind randomized controlled trial and enrolling caregivers through UChicago-affiliated clinic sites. Caregivers will be screened and asked about unmet health-related social needs at the outpatient visit. Eligible, self-identified caregivers will complete an in-person baseline survey on-site (face to face), followed by phone surveys at 7, 30, 90 days, and 12 months. Caregivers randomized to the intervention will receive tailored information on community resources for their identified health-related social needs. They will also be given access to an online community-resource tool and shown how to use it, so they can search for additional resources in their community beyond the point-of-care and outside of the clinic. All caregivers (regardless of research arm) will also receive a series of text messages related to the study such as reminders to schedule the phone survey with a member of the research team. The anticipated sample (n=414) includes pretest participants (n=20), RCT participants enrolled in the 12-month RCT (n=344) and additional men caregivers enrolled in a 3-month RCT (N=50).
Interventions
BEHAVIORALCommunity Rx-Dementia "CRxD" Caregiver Resources
A tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder.
Sponsors
University of Chicago
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Intervention model description
Cases will receive the CRx-D Intervention. Controls will not receive the intervention but will receive the usual standard of care.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Resides in the target geographic region of the study (living in 1 of the 35 target zip codes) * Self-identifies as a caregiver of a home-dwelling person with Alzheimer's Disease or related dementia using an adaptation of the BRFSS caregiver module * Has access to a cell phone and provides the research interviewer with the cell phone number * Agrees to receive text messages from the study * Has a personal email address. * Self-report their gender identity to be male or trans male/trans man (only for additional 50 caregivers enrolled in the 3-month RCT)
Exclusion criteria
* Past enrollment in the CommunityRx-C study * Recollection of previous receipt of a HealtheRx
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Self-efficacy at 12 Months Among Caregivers With Unmet Health Related Social Needs | 12 months | Self-efficacy is measured with a 4-item sub-domain from the 2015 Caregiver Dementia Care and Self-Efficacy Survey (Jennings et al). Responses to each of the items are scored between 1 = "strongly disagree" to 5 = "strongly agree" and will generate an average score. Higher values = greater self-efficacy |
| Satisfaction With Care | 7 days | Satisfaction will be assessed using the Patient Satisfaction Questionnaire 18-item short form (PSQ-18), specifically the general satisfaction sub-scale (2 questions). Five possible response options for each of the two items are scored 1 to 5; with a higher score equating to higher satisfaction. Scores will be transformed using the formula: y= 100 \* (x-a)/(b-a) where y=the transformed score, x=the original score, a=the minimum possible score and b=the maximum possible score. Transformed items will be averaged to generate the composite score (range 0-100; higher scores indicating greater satisfaction). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cases - Main Randomized Trial Community Rx-Dementia CRxD Caregiver Resources, Enrolled as part of the Main Randomized Trial
Community Rx-Dementia CRxD Caregiver Resources: A tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder. | 170 |
| Control - Main Randomized Trial Usual Standard Care - Enrolled as part of the Main Randomized Trial | 173 |
| Cases - Supplement Community Rx-Dementia CRxD Caregiver Resources, Enrolled as part of the Supplement
Community Rx-Dementia CRxD Caregiver Resources: A tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder. | 7 |
| Control - Supplement Usual Standard Care - Enrolled as part of the Supplement | 9 |
| Total | 359 |
Baseline characteristics
| Characteristic | Control - Main Randomized Trial | Cases - Main Randomized Trial | Total | Control - Supplement | Cases - Supplement |
|---|---|---|---|---|---|
| Age, Continuous | 59.0 years STANDARD_DEVIATION 12 | 59.9 years STANDARD_DEVIATION 11.8 | 59.4 years STANDARD_DEVIATION 12 | 58.6 years STANDARD_DEVIATION 13.5 | 58.7 years STANDARD_DEVIATION 15.3 |
| Presence of at least 1 health-related social risk factor None | 104 Participants | 106 Participants | 219 Participants | 4 Participants | 5 Participants |
| Presence of at least 1 health-related social risk factor One or more | 69 Participants | 64 Participants | 140 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic | 7 Participants | 7 Participants | 15 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 132 Participants | 142 Participants | 286 Participants | 5 Participants | 7 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 16 Participants | 11 Participants | 30 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 15 Participants | 10 Participants | 25 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 173 participants | 170 participants | 359 participants | 9 participants | 7 participants |
| Sex: Female, Male Female | 135 Participants | 133 Participants | 268 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 38 Participants | 36 Participants | 90 Participants | 9 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 177 | 0 / 182 |
| other Total, other adverse events | 0 / 177 | 0 / 182 |
| serious Total, serious adverse events | 0 / 177 | 0 / 182 |
Outcome results
Primary
Caregiver Self-efficacy at 12 Months Among Caregivers With Unmet Health Related Social Needs
Self-efficacy is measured with a 4-item sub-domain from the 2015 Caregiver Dementia Care and Self-Efficacy Survey (Jennings et al). Responses to each of the items are scored between 1 = strongly disagree to 5 = strongly agree and will generate an average score. Higher values = greater self-efficacy
Time frame: 12 months
Population: Analysis was restricted to caregivers in the main randomized trial who had at least 1 unmet health-related social need at baseline and completed the self-efficacy measure at 12 month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cases | Caregiver Self-efficacy at 12 Months Among Caregivers With Unmet Health Related Social Needs | 3.5 score on a scale | Standard Deviation 0.7 |
| Control | Caregiver Self-efficacy at 12 Months Among Caregivers With Unmet Health Related Social Needs | 3.5 score on a scale | Standard Deviation 1 |
Primary
Satisfaction With Care
Satisfaction will be assessed using the Patient Satisfaction Questionnaire 18-item short form (PSQ-18), specifically the general satisfaction sub-scale (2 questions). Five possible response options for each of the two items are scored 1 to 5; with a higher score equating to higher satisfaction. Scores will be transformed using the formula: y= 100 \* (x-a)/(b-a) where y=the transformed score, x=the original score, a=the minimum possible score and b=the maximum possible score. Transformed items will be averaged to generate the composite score (range 0-100; higher scores indicating greater satisfaction).
Time frame: 7 days
Population: Analysis was restricted to caregivers in the main randomized trial who completed the satisfaction measure at 1 week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cases | Satisfaction With Care | 71.4 score on a scale | Standard Deviation 19.3 |
| Control | Satisfaction With Care | 69.6 score on a scale | Standard Deviation 21.8 |