An interventional study of Tele-Savvy and Caregiving During Crisis (Educational Program) in Alzheimer Disease, Dementia and Brain Diseases, sponsored by UConn Health. Completed at 2 sites in United States. Open to participants aged 18 Years to 110 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by UConn Health · Not applicable, Interventional, and Other
This cluster randomized pragmatic clinical trial will test the effectiveness and feasibility of embedding the Tele-Savvy intervention, a psychoeducational program for family and other informal caregivers of older adults living in the community with Alzheimer's disease and related dementia (ADRD), in two health care systems/clinical sites: UConn Health in Farmington, Connecticut, and Emory Healthcare in Atlanta, Georgia.
This cluster randomized pragmatic clinical trial will test the effectiveness and feasibility of embedding the Tele-Savvy intervention, a psychoeducational program for family and other informal caregivers of older adults living in the community with Alzheimer's disease and related dementia (ADRD), in two health care systems/clinical sites: UConn Health in Farmington, Connecticut, and Emory Healthcare in Atlanta, Georgia. A total of 100 caregivers, 50 at each study site, will participate in this pilot study. At each site, 30 caregivers will be randomly assigned to receive the Tele-Savvy intervention, and 20 caregivers will be randomly assigned to receive the self-guided Caregiving During Crisis online program.
All 100 caregivers will complete identical self-administered questionnaires to measure the caregiver-specific outcome measures in this pilot study. Outcome measures will include caregiver mastery (primary outcome), caregiver response to specific memory and behavioral problems, and caregiver stress. Also, we will employ process measures of participation and engagement in the interventions for caregivers in both arms of the trial, as well as implementation outcomes via surveys with clinicians and Information Technology staff at each of the two clinical sites responsible for programming electronic medical records to enable capture and storage of caregiver outcomes.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's enrollment of 74 is close to the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →UConn Health is the lead sponsor of 187 studies on the registry; 18 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
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Exclusion Criteria:
The participants will be enrolled into the Tele-Savvy group. Software analytics monitor caregivers' use of asynchronous material each week.
Behavioral: Tele-Savvy
The participants will be enrolled in the Caregiving During Crisis program. Software analytics monitor caregivers' use of asynchronous material each week.
Behavioral: Caregiving During Crisis (Educational Program)
A low-risk, psychoeducational, group-based intervention, is grounded in social learning and stress process theory and its main goal is to produce improved caregiver mastery over the symptom management skills commonly encountered when supervising and caring at home for an older adult living with ADRD. Over the 7-week program, there are synchronous and asynchronous activities each week. The synchronous portion includes weekly scheduled videoconferences (60-80 min) that serve as an online classroom in which facilitators lead lectures and discussions. Daily, caregivers access online 6- to 15-min prerecorded videos, each focused on one main learning objective. Caregivers can watch the lessons whenever and as often as they wish.
The attention control group will receive the self-guided Caregiving During Crisis program. Caregiving During Crisis is a fully online, asynchronous, professionally designed continuing education course aimed at developing the competency of informal caregivers of community-dwelling persons living with dementia to ensure the safety of that person and themselves during this time of the COVID-19 pandemic. The course, readily accessible by home computer or smartphone, describes methods of home infection control and prevention to create a Safe Home space, strategies for safely leaving and re-entering the home (e.g., to shop), additional strategies for safely allowing service personnel (e.g., home health aides or electricians) and select family members to enter the Safe Home space, and risk management strategies to frame decisions when/if COVID restrictions are relaxed or revoked.
Change in Caregiver Mastery
Caregiving competence scale, minimum and maximum values 4-16, higher scores mean greater mastery.
Time frame: pre-randomization; 3 months post-randomization; and 6 months post-randomization (6 months post-randomization for Emory site only)
Change in Caregiver Reactions
The reactions caregivers have to the behavioral and psychological symptoms expressed by persons living with dementia, were assessed using the Revised Memory and Behavior Problem Checklist (RMBPC). The RMBPC is a 24-item scale capturing caregiver reactions to 24 memory and behavior problems. Scores are computed based on the presence or absence of each problem first, and then for caregiver "reaction" or the extent to which caregivers were "bothered" or "upset" by each endorsed behavior. Reactions are assessed by asking how "upsetting" each behavior is to the caregiver on a Likert scale of 0 to 4 (0 = Not at all, 1= a little, 2 = moderately, 3 = very much, and 4 =extremely). Scores on the scale can range from 0-96, with higher scores meaning a worse outcome.
Time frame: pre-randomization; 3 months post-randomization; and 6 months post-randomization (6 months post-randomization for Emory site only)
Change in Caregiver Stress
The Perceived Stress Scale (PSS) is a 14-item instrument designed to measure the degree to which situations in one's life are appraised as stressful. Higher score reflects higher perceived stress. PSS items were designed to tap the degree to which respondents found their lives unpredictable, uncontrollable, and overloading. The scale also includes a number of direct queries about current levels of experienced stress. Each item is scored from 0 (never) to 4 (very often), for a possible score range of 0-56, with higher scores meaning worse outcomes.
Time frame: pre-randomization; 3 months post-randomization; and 6 months post-randomization (6-month post randomization for Emory site only)
| Milestone | Tele-Savvy Group | Attention Control Group |
|---|---|---|
| Started | 44 | 30 |
| Completed | 26 | 10 |
| Not completed | 18 | 20 |
Caregiving competence scale, minimum and maximum values 4-16, higher scores mean greater mastery.
| score on a scale | Tele-Savvy Group | Attention Control Group |
|---|---|---|
| Scores at baseline | 10.9 ± 2.1 | 11.5 ± 2.0 |
| Scores at 3-month follow-up | 12.4 ± 2.0 | 12.0 ± 2.0 |
| Scores at 6-month follow-up | 12.7 ± 1.3 | 12.8 ± 2.7 |
The reactions caregivers have to the behavioral and psychological symptoms expressed by persons living with dementia, were assessed using the Revised Memory and Behavior Problem Checklist (RMBPC). The RMBPC is a 24-item scale capturing caregiver reactions to 24 memory and behavior problems. Scores are computed based on the presence or absence of each problem first, and then for caregiver "reaction" or the extent to which caregivers were "bothered" or "upset" by each endorsed behavior. Reactions are assessed by asking how "upsetting" each behavior is to the caregiver on a Likert scale of 0 to 4 (0 = Not at all, 1= a little, 2 = moderately, 3 = very much, and 4 =extremely). Scores on the scale can range from 0-96, with higher scores meaning a worse outcome.
| score on a scale | Tele-Savvy Group | Attention Control Group |
|---|---|---|
| Scores at baseline | 22.4 ± 10.9 | 19.4 ± 12.3 |
| Scores at 3-month follow-up | 17.6 ± 12.2 | 9.4 ± 13.0 |
| Scores at 6-month follow-up | 17.2 ± 8.7 | 10.1 ± 7.3 |
The Perceived Stress Scale (PSS) is a 14-item instrument designed to measure the degree to which situations in one's life are appraised as stressful. Higher score reflects higher perceived stress. PSS items were designed to tap the degree to which respondents found their lives unpredictable, uncontrollable, and overloading. The scale also includes a number of direct queries about current levels of experienced stress. Each item is scored from 0 (never) to 4 (very often), for a possible score range of 0-56, with higher scores meaning worse outcomes.
| score on a scale | Tele-Savvy Group | Attention Control Group |
|---|---|---|
| Scores at baseline | 25.6 ± 6.6 | 24.5 ± 9.5 |
| Scores at 3-month follow-up | 21.1 ± 5.5 | 15.2 ± 7.3 |
| Scores at 6-month follow-up | 19.9 ± 5.7 | 16.8 ± 9.2 |
Collected over In this pragmatic clinical trial testing an education and support intervention, adverse event occurrence was monitored during the 7-week duration of the intervention period for each caregiver.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tele-Savvy Group | 0/44 (0%) | 0/44 (0%) | 0/44 (0%) |
| Attention Control Group | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Continuous(years) | Tele-Savvy Group | Attention Control Group | Total |
|---|---|---|---|
| Mean | 66.0 ± 12.1 | 63.7 ± 11.2 | 65.1 ± 11.7 |
| Sex: Female, Male(Participants) | Tele-Savvy Group | Attention Control Group | Total |
|---|---|---|---|
| Female | 32 | 22 | 54 |
| Male | 12 | 8 | 20 |
| Ethnicity (NIH/OMB)(Participants) | Tele-Savvy Group | Attention Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 44 | 30 | 74 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Tele-Savvy Group | Attention Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 6 | 7 | 13 |
| White | 38 | 21 | 59 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Tele-Savvy Group | Attention Control Group | Total |
|---|---|---|---|
| United States | 44 | 30 | 74 |
| Marital Status(Participants) | Tele-Savvy Group | Attention Control Group | Total |
|---|---|---|---|
| Married | 35 | 23 | 58 |
| Not Married | 9 | 7 | 16 |
| Educational level(Participants) | Tele-Savvy Group | Attention Control Group | Total |
|---|---|---|---|
| High school or some college | 7 | 6 | 13 |
| College degree | 15 | 11 | 26 |
| Graduate degree | 22 | 13 | 35 |
| Relationship to person with dementia(Participants) | Tele-Savvy Group | Attention Control Group | Total |
|---|---|---|---|
| Spouse/partner | 26 | 13 | 39 |
| Daughter | 13 | 11 | 24 |
| Son | 3 | 4 | 7 |
| Sibling | 1 | 1 | 2 |
| Other family member | 1 | 0 | 1 |
| Unknown | 0 | 1 | 1 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2021 to primary completion in Jun 2023, 20 months.
Results were first posted in Feb 2025, 1 year 8 months after primary completion.
Of 882 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's 20 months is below that.
Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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