Testing Tele-Savvy, an On-line Psychoeducation Program for Dementia Family Caregivers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03033875

Enrollment

261

Registered

2017-01-27

Start date

2017-05-18

Completion date

2020-12-04

Last updated

2022-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Dementia

Brief summary

The purpose of this study is to test the psychoeducational program Tele-Savvy. Tele-Savvy is an internet based, group education program developed from an in person program called Savvy Caregiver. Participants will be randomly assigned to either the Tele-Savvy group (receiving only the Tele-Savvy education) or the Healthy Living Education Program (receiving healthy lifestyle education and then Tele-Savvy education 6 months later) or a usual care group (receiving Tele-Savvy education 6 months later). Each program takes 43 days to complete.

Detailed description

This study addresses the reliance on family members to provide virtually all community-based care for 5.3 million persons living with Alzheimer's disease and other dementias, a population that will likely triple in the next 35 years. Unless researchers soon find a way to prevent and cure dementing illnesses like Alzheimer's, the country will continue to face an urgent need to find ways to sustain and bolster the capacity of these family caregivers to manage the multiple daily care challenges they face and to preserve their well-being while doing so. Without family caregivers, the burden of care could well overwhelm the formal components of our care system. A number of psychoeducation programs for caregivers have been effective in relieving distress, increasing self-efficacy, managing caregiving challenges, and enabling caregivers to sustain care over longer periods of time. However, many Alzheimer's caregivers cannot take part in these programs because virtually all such programs require caregivers to arrange care for the care recipient while the caregivers attend the programs. These are obstacles in rural or remote areas where transportation issues further restrict caregivers' already limited access to caregiver programs, but they are no less a problem in inner cities and suburbs. These obstacles highlight a substantial challenge to our ability to rely on caregivers as a continuing care resource for persons living with Alzheimer's disease: there is a need for theory-driven psychoeducation programs that can be made readily available to caregivers who may not be able to attend in-person programs. This is a randomized trial to test a program designed to meet this critical need. This study will test Tele-Savvy, an internet-based program based on the widely disseminated, in-person Savvy Caregiver psychoeducation program. Delivered in scheduled videoconferences and independently viewed on-line video lessons, Tele-Savvy aims to develop/enhance caregivers' skills and caregiving mastery, reduce adverse effects of caregiving, and improve the quality of the lives of caregivers and care recipients. Caregivers will be randomly assigned either to immediate Tele-Savvy participation groups or to attention control or usual care groups that are invited to participate in Tele-Savvy six months after baseline data collection. Each program takes 43 days to complete. In those 43 days, participants will be asked to take part in a video conference once per week (60-90 minutes) and view daily video lessons (7-15 minutes). The study includes 5 interviews over the course of the 12 month study; the interviews at baseline and months 3 and 6 assess the study outcome measures. These interviews will discuss participant's experience as a caregiver. All interviews will be limited to 60 minutes.

Interventions

BEHAVIORALTele-Savvy

The Tele-Savvy program engages groups of six dementia family caregivers in a program that extends over 43 days. The program begins with a scheduled 75-minute group videoconference led by facilitators; similar group videoconferences then take place weekly for six weeks. In between the video-conferences, caregivers will receive daily emails with links to 5-15 minute on-line video lessons that can be watched on their own schedule as often as they wish. The videoconferences allow caregivers to report enactment of learned and self-developed management strategy behaviors into their own caregiving and allow them to raise questions. Each daily video presents a teaching point linked to the overall curriculum. The lesson is carried forward by brief, scripted talks by experts or is enacted in vignettes in which a fictional family caring for a father living with Alzheimer's demonstrates effective caregiving techniques linked to the day's teaching points.

BEHAVIORALHealthy Living Education Program

The Healthy Living Education Program contains video and text materials on exercise, diet, and healthy living. Participants will be asked to log into the Canvas site daily over the course of six weeks to view the videos. Each participant will also receive 7 weekly brief scripted phone or video calls from a project facilitator to inquire about participants' use of the materials. Additionally, all participants will convene weekly for a video conference centered on the application of healthy living strategies. Facilitators will greet and check in with each of the caregivers, coach and debrief caregivers on the homework, answer questions and/or respond to feedback about the week's material, review key points and concepts from the week's video sessions and introduce new material, report on any activities that caregivers may have implemented based on the materials, and provide homework assignments.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Intervention model description

Participants will be randomly assigned in a 2:2:1 ratio to the Tele-Savvy intervention, Healthy Living intervention, or usual care condition. Participants in the Healthy Living and usual care arms can take part i the Tele-Savvy intervention after a delay of 6 months.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Informal caregivers (family/friends) of persons living with Alzheimer's disease or another dementia * Participants must be providing at least 4 hours per day unpaid assistance, on average, for a person in the early-middle stage of illness (Clinical Dementia Rating of greater than or equal to 1 by home ADC) who is community-dwelling and for whom there is no established plan for institutionalization in the next six months * Caregiver may or may not reside with their care recipient, but care recipients must live in the community and not in an assisted living facility, nursing home, or another institutional setting * Must have access to a computer or a mobile device with adequate internet connection, microphone, and speakers (to be able to participate in teleconferences) and be able to use email * Able to read, speak and understand English

Exclusion criteria

* The participant must not be involved in another caregiver training study and must not have participated in in-person Savvy Caregiver Program or Tele-Savvy previously * Uncorrectable vision or hearing deficits that might impede participation

Design outcomes

Primary

Measure	Time frame	Description
Zarit Burden Inventory (ZBI) Score	Baseline, Month 3, Month 6	The ZBI is a 22 item scale. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total scores range from 0 (low burden) to 88 (high burden)
State-Trait Anxiety Inventory (STAI) State Score	Baseline, Month 3, Month 6	The STAI State (STAI-S) is a 20-item 4-point Likert scale commonly used measure of state anxiety. Respondents report the intensity of their anxiety at that moment on a 4-point scale where 1 = not at all and 4 = very much so. Total scores range from 20 to 80 and higher scores indicate greater anxiety.
Center for Epidemiological Studies Depression Scale - Revised (CESD-R) Score	Baseline, Month 3, Month 6	The CESD-R is a 20 item Likert scale scored 0-3 with somatic and psychological subscales. Total scores range from 0 to 60, with high scores indicating greater depressive symptoms.

Secondary

Measure	Time frame	Description
Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score	Baseline, Month 3, Month 6	The RMBPC is a 24-item instrument that assesses behaviors in persons with dementia and caregiver responses to them. Caregiver reactions to behaviors are scored as 0 = not at all upsetting to 4 = extremely upsetting. Total caregiver reaction scores range from 0 to 96 with higher scores indicating greater feelings of being upset by behaviors of those with dementia that they are providing care for.
Perceived Stress Scale (PSS) Score	Baseline, Month 3, Month 6	The PSS is 14-item Likert-type questionnaire. Responses are given on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 56 and certain items are reverse scored so that higher total scores reflect higher perceived stress.
Pearlin Mastery, Loss, and Competence - Caregiving Competence Subscale Score	Baseline, Month 3, Month 6	The Caregiving Competence Subscale of the Pearlin Mastery, Loss, and Competence instrument has 4 items that are responded to on a 4-point Likert scale where 1 = not at all and 4 = very much. Total scores for this subscale range from 4 to 16 and higher scores indicate greater feelings of competence with caregiving.
Pearlin Mastery, Loss, and Competence - Management of Situation Subscale Score	Baseline, Month 3, Month 6	The Management of Situation Subscale of the Pearlin Mastery, Loss, and Competence instrument has 4 items that are responded to on a 4-point Likert scale where 1 = never and 4 = very often. Total scores for this subscale range from 4 to 16 and higher scores indicate greater management of caregiving situations.

Countries

United States

Participant flow

Recruitment details

Participant enrollment began May 18, 2017 and all study follow up was completed by December 4, 2020. Data collection to assess the outcome measures for this study occurred through the interview at month 6. Study activities continued through month 12 while participants in the Attention Control and Usual Care groups had the opportunity to have the Tele-Savvy intervention.

Participants by arm

Arm	Count
Tele-Savvy Group Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.	96
Attention Control Group Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.	111
Usual Care Group Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.	54
Total	261

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Other	14	15	8
Overall Study	Withdrawal by Subject	5	9	4

Baseline characteristics

Characteristic	Tele-Savvy Group	Total	Usual Care Group	Attention Control Group
Age, Continuous	66.0 years STANDARD_DEVIATION 10.9	64.6 years STANDARD_DEVIATION 11.2	63.7 years STANDARD_DEVIATION 10.7	63.8 years STANDARD_DEVIATION 11.6
Age of person cared for	75.1 years STANDARD_DEVIATION 8.6	74.6 years STANDARD_DEVIATION 9.8	74.4 years STANDARD_DEVIATION 10.3	74.4 years STANDARD_DEVIATION 10.6
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	92 Participants	250 Participants	54 Participants	104 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants	11 Participants	0 Participants	7 Participants
Race/Ethnicity, Customized Caregiver race African American/Black	15 Participants	57 Participants	15 Participants	27 Participants
Race/Ethnicity, Customized Caregiver race Asian	1 Participants	4 Participants	0 Participants	3 Participants
Race/Ethnicity, Customized Caregiver race No answer	0 Participants	1 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized Caregiver race Other	2 Participants	7 Participants	0 Participants	5 Participants
Race/Ethnicity, Customized Caregiver race White	78 Participants	192 Participants	39 Participants	75 Participants
Region of Enrollment United States	96 Participants	261 Participants	54 Participants	111 Participants
Relation to person cared for Non-spouse	27 Participants	89 Participants	19 Participants	43 Participants
Relation to person cared for Spouse	69 Participants	172 Participants	35 Participants	68 Participants
Sex: Female, Male Female	72 Participants	184 Participants	39 Participants	73 Participants
Sex: Female, Male Male	24 Participants	77 Participants	15 Participants	38 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 96	0 / 111	0 / 54
other Total, other adverse events	0 / 96	0 / 111	0 / 54
serious Total, serious adverse events	0 / 96	0 / 111	0 / 54

Outcome results

Primary

Center for Epidemiological Studies Depression Scale - Revised (CESD-R) Score

The CESD-R is a 20 item Likert scale scored 0-3 with somatic and psychological subscales. Total scores range from 0 to 60, with high scores indicating greater depressive symptoms.