Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurocognitive Disorders, Neurodegenerative Diseases, Mental Disorders
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALTele-Savvy
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.
BEHAVIORALCaregiving During Crisis (Educational Program)
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.
Sponsors
Emory University
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Three Tele-Savvy programs, with 10 caregivers in each Tele-Savvy program cohort, will be held sequentially at each health care system site, for a total of 60 caregivers in 6 Tele-Savvy cohorts. Recruitment will occur in three waves, whereby caregivers will be randomly assigned at a 3:2 ratio to either Tele-Savvy or the attention control group until the first Tele-Savvy cohort is filled (first wave), followed by the same randomization procedure until the second and third Tele-Savvy cohorts are filled.
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
Yes
Inclusion criteria
* Identified by EHR systems and confirmed by a health care provider as a family member or unpaid significant other who provides care at home for an older adult (age 65 or older) living with ADRD * English speaking * Able to understand study procedures and comply with them for the entire length of the study * Access to appropriate video and audio technology to be able to participate in interventions
Exclusion criteria
* Unwilling to be randomized to receive either Tele-Savvy or Caregiving During Crisis * Planning to admit the person living with ADRD to a nursing home on a long-term basis within 6 months of randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Caregiver Mastery | pre-randomization; 3 months post-randomization; and 6 months post-randomization (6 months post-randomization for Emory site only) | Caregiving competence scale, minimum and maximum values 4-16, higher scores mean greater mastery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Caregiver Reactions | pre-randomization; 3 months post-randomization; and 6 months post-randomization (6 months post-randomization for Emory site only) | 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. |
| Change in Caregiver Stress | pre-randomization; 3 months post-randomization; and 6 months post-randomization (6-month post randomization for Emory site only) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tele-Savvy Group The participants will be enrolled into the Tele-Savvy group. Software analytics monitor caregivers' use of asynchronous material each week.
Tele-Savvy: 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. | 44 |
| Attention Control Group The participants will be enrolled in the Caregiving During Crisis program. Software analytics monitor caregivers' use of asynchronous material each week.
Caregiving During Crisis (Educational Program): 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. | 30 |
| Total | 74 |
Baseline characteristics
| Characteristic | Tele-Savvy Group | Attention Control Group | Total |
|---|---|---|---|
| Age, Continuous | 66.0 years STANDARD_DEVIATION 12.1 | 63.7 years STANDARD_DEVIATION 11.2 | 65.1 years STANDARD_DEVIATION 11.7 |
| Difficulty paying for basic needs Not difficult at all | 32 Participants | 17 Participants | 49 Participants |
| Difficulty paying for basic needs Not very difficult, somewhat or very difficult | 12 Participants | 13 Participants | 25 Participants |
| Educational level College degree | 15 Participants | 11 Participants | 26 Participants |
| Educational level Graduate degree | 22 Participants | 13 Participants | 35 Participants |
| Educational level High school or some college | 7 Participants | 6 Participants | 13 Participants |
| Employed for pay outside the home No | 30 Participants | 22 Participants | 52 Participants |
| Employed for pay outside the home Yes | 14 Participants | 8 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 30 Participants | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Marital Status Married | 35 Participants | 23 Participants | 58 Participants |
| Marital Status Not Married | 9 Participants | 7 Participants | 16 Participants |
| Primary caregiver No | 8 Participants | 3 Participants | 11 Participants |
| Primary caregiver Yes | 36 Participants | 27 Participants | 63 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 7 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 38 Participants | 21 Participants | 59 Participants |
| Region of Enrollment United States | 44 participants | 30 participants | 74 participants |
| Relationship to person with dementia Daughter | 13 Participants | 11 Participants | 24 Participants |
| Relationship to person with dementia Other family member | 1 Participants | 0 Participants | 1 Participants |
| Relationship to person with dementia Sibling | 1 Participants | 1 Participants | 2 Participants |
| Relationship to person with dementia Son | 3 Participants | 4 Participants | 7 Participants |
| Relationship to person with dementia Spouse/partner | 26 Participants | 13 Participants | 39 Participants |
| Relationship to person with dementia Unknown | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 32 Participants | 22 Participants | 54 Participants |
| Sex: Female, Male Male | 12 Participants | 8 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 30 |
| other Total, other adverse events | 0 / 44 | 0 / 30 |
| serious Total, serious adverse events | 0 / 44 | 0 / 30 |
Outcome results
Primary
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)
Population: In the Tele-Savvy group, 40 participants had baseline data, 24 participants had 3-month follow-up data, and 16 participants had 6-month follow-up data. In the Attention Control group, 28 participants had baseline data, 10 participants had 3-month follow-up data, and 8 participants had 6-month follow-up data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tele-Savvy Group | Change in Caregiver Mastery | Scores at baseline | 10.9 score on a scale | Standard Deviation 2.1 |
| Tele-Savvy Group | Change in Caregiver Mastery | Scores at 3-month follow-up | 12.4 score on a scale | Standard Deviation 2 |
| Tele-Savvy Group | Change in Caregiver Mastery | Scores at 6-month follow-up | 12.7 score on a scale | Standard Deviation 1.3 |
| Attention Control Group | Change in Caregiver Mastery | Scores at baseline | 11.5 score on a scale | Standard Deviation 2 |
| Attention Control Group | Change in Caregiver Mastery | Scores at 3-month follow-up | 12.0 score on a scale | Standard Deviation 2 |
| Attention Control Group | Change in Caregiver Mastery | Scores at 6-month follow-up | 12.8 score on a scale | Standard Deviation 2.7 |
Comparison: Null hypothesis was that there would be no group differences, no time differences, and no group x time differences, in changes over time between the two treatment groups. Because this was a pilot and feasibility study, no power calculations were conducted.p-value: 0.295Multilevel modeling (MLM)
Secondary
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)
Population: In the Tele-Savvy group, 43 participants had baseline data, 26 participants had 3-month follow-up data, and 14 participants had 6-month follow-up data. In the Attention Control group, 29 participants had baseline data, 10 participants had 3-month follow-up data, and 8 participants had 6-month follow-up data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tele-Savvy Group | Change in Caregiver Reactions | Scores at 6-month follow-up | 17.2 score on a scale | Standard Deviation 8.7 |
| Tele-Savvy Group | Change in Caregiver Reactions | Scores at baseline | 22.4 score on a scale | Standard Deviation 10.9 |
| Tele-Savvy Group | Change in Caregiver Reactions | Scores at 3-month follow-up | 17.6 score on a scale | Standard Deviation 12.2 |
| Attention Control Group | Change in Caregiver Reactions | Scores at baseline | 19.4 score on a scale | Standard Deviation 12.3 |
| Attention Control Group | Change in Caregiver Reactions | Scores at 3-month follow-up | 9.4 score on a scale | Standard Deviation 13 |
| Attention Control Group | Change in Caregiver Reactions | Scores at 6-month follow-up | 10.1 score on a scale | Standard Deviation 7.3 |
Comparison: Null hypothesis was that there would be no group differences, no time differences, and no group x time differences, in changes over time between the two treatment groups. Because this was a pilot and feasibility study, no power calculations were conducted.p-value: 0.57MLM
Secondary
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)
Population: In the Tele-Savvy group, 44 participants had baseline data, 26 participants had 3-month follow-up data, and 15 participants had 6-month follow-up data. In the Attention Control group, 30 participants had baseline data, 10 participants had 3-month follow-up data, and 8 participants had 6-month follow-up data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tele-Savvy Group | Change in Caregiver Stress | Scores at baseline | 25.6 score on a scale | Standard Deviation 6.6 |
| Tele-Savvy Group | Change in Caregiver Stress | Scores at 3-month follow-up | 21.1 score on a scale | Standard Deviation 5.5 |
| Tele-Savvy Group | Change in Caregiver Stress | Scores at 6-month follow-up | 19.9 score on a scale | Standard Deviation 5.7 |
| Attention Control Group | Change in Caregiver Stress | Scores at baseline | 24.5 score on a scale | Standard Deviation 9.5 |
| Attention Control Group | Change in Caregiver Stress | Scores at 3-month follow-up | 15.2 score on a scale | Standard Deviation 7.3 |
| Attention Control Group | Change in Caregiver Stress | Scores at 6-month follow-up | 16.8 score on a scale | Standard Deviation 9.2 |
Comparison: Null hypothesis was that there would be no group differences, no time differences, and no group x time differences, in changes over time between the two treatment groups. Because this was a pilot and feasibility study, no power calculations were conducted.p-value: 0.461MLM