DementiaNCT04951037

Producing a Fully Asynchronous Online Savvy Program

A study testing Fully Asynchronous Online Savvy Program in people with Dementia, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a pilot/feasibility study to develop and test a fully online, self-administered psychoeducation program to enhance the caregiving mastery of family and friends who provide unpaid care for persons living with Alzheimer's and similar dementia disorders (PLWD). Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Dementia
What is being tested?: Fully Asynchronous Online Savvy Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 15 Sep 2021to 2 Sep 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

primary unpaid caregiver for a community-dwelling PLWD
provide at least 10 hours of direct care per week
able to read and understand English
be able to access the course online
naïve to Savvy or Tele-Savvy

Who cannot join

cannot provide consent
prisoners
cognitively impaired adult
not able to clearly understand English

Trial locations and contacts

1 site in 1 country.

United States1 site

Emory University
Atlanta, Georgia, 30322

Other trials in United States

About this study

Read the detailed description

This study seeks to develop and test a fully online, self-administered psychoeducation program to enhance the caregiving mastery of family and friends who provide unpaid care for persons living with Alzheimer's and similar dementia disorders (PLWD). As the number of PLWD rises in the United States from the perhaps 7 million today to possibly 15 million in 2050, the healthcare system will rely on those caregivers even more. It is well established that family caregiving is taxing and stressful and that managing the day-to-day life of PLWD and handling the behavioral and psychological symptoms in dementia (BPSD) that they may exhibit are the main sources of stress. Group-based psychoeducational programs such as the Savvy Caregiver program (SCP) have demonstrated that the acquisition of skills, knowledge, and caregiving mastery can ameliorate caregiving stress - and enhance PLWD quality of life. Many factors, however, preclude caregivers' attendance in group-based programs and limit programs' scalability. To address the issue of access, the researchers have developed the Tele-Savvy program, an online version of SCP that brings groups of caregivers together in facilitator-led synchronous groups and provides substantive educational augmentation through asynchronous e-mail-delivered video lessons.

The first aim of this study is to develop a fully asynchronous online Savvy program that incorporates learning activities that promote both knowledge and skill acquisition and develop and enhance caregivers' felt-sense of caregiving mastery. Developing this education program will utilize input from clinicians, educators, Tele-Savvy facilitators, and caregiver advisors. The second study aim is to determine the feasibility, acceptability and preliminary efficacy of the created online program. This study will recruit 60 family caregivers to take part in a no-control trial of the program. Data will be gathered at baseline, immediately upon course completion and at 3 months post-baseline to assess caregiver distress measures (depression, strain, burden, anxiety), caregiver competence/ mastery, and care recipient quality of life.

Conditions: Dementia
Being tested: Fully Asynchronous Online Savvy Program
Keywords: Dementia caregiver
Medical subject headings: Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fully Asynchronous Online Savvy ProgramBehavioural
Also called Tele-Savvy
The intervention is a fully online, self-administered psychoeducational program designed to enhance caregiver mastery for family and friends providing unpaid care for living with Alzheimer's and similar dementia disorders. Participants will be asked to engage with a fully online version of Tele-Savvy for 42 days.
Participants will receive a series of daily video lessons related to caregiving. These lessons are generally 8-15 minutes in length and are emailed to participants. Participants can watch the lessons whenever and as often as they wish over the course of the study. There will also be self-guided learning strategies and exercises to accomplish skill and mastery related to the caregiving role. The lessons cover a variety of topics including:
- Facts about dementing Illnesses
- Caregiving Strategies - guiding the person through days that are as safe, calm, and pleasant as possible
- Self-Care for the Caregiver

Study groups in NCT04951037
Study group	Role	What they receive
Fully Asynchronous Online Savvy Program	Experimental	Family caregivers of PLWD taking part in a fully asynchronous online caregiver education program. Receives: Behavioral: Fully Asynchronous Online Savvy Program

What is being measured

The primary outcome is the main question the study is designed to answer.

Center for Epidemiologic Studies - Depression (CES-D) Score
The CES-D is a 20-item self-report instrument asking respondents if they have experienced symptoms of depression during the past week. Responses are given on a scale of 0 to 3 where "rarely" = 0 and "most of the time" = 3. Total scores range from 0 to 60 and higher scores indicate greater symptoms of depression.
Measured: Baseline, Month 2, Month 3
Zarit Burden Interview Score
The Zarit Burden Interview is a 22-item scale of objective and subjective caregiver burden. Responses are given on a 5-point scale where 0 = never and 4 = nearly always. Total scores range from 0 to 88 where higher scores indicate greater feelings of being burdened with providing care.
Measured: Baseline, Month 2, Month 3
State-Trait Anxiety Inventory (STAI) Score
The STAI is a 20-item self-report scale of positive and negative anxiety experiences. Responses are given 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.
Measured: Baseline, Month 2, Month 3
Caregiver Mastery Scale - Caregiving Competence Score
The Caregiving Mastery instrument assesses caregiver mastery of 3 different realms of caregiving situations: Relational Deprivation, Caregiving Competence, and Management of Situation. The Caregiving Competence subscale asks caregivers about their thoughts about the caregiving they provide with 4 items where responses are given on a 4-point scale where "not at all" = 1 and "completely" or "very" = 4. Total scores range from 4 to 16 where higher scores indicate greater feelings of competence with caregiving.
Measured: Baseline, Month 2, Month 3
Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score
The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate how frequently problems have occurred on a 5-point scale where 0 = never occurred and 4 = daily or more often. Total frequency scores range from 0 to 96 with higher scores indicating greater frequency of memory and behavior problems exhibited by the PLWD.
Measured: Baseline, Month 2, Month 3
Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score
The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate the degree to which problems have bothered or upset them on a 5-point scale where 0 = not at all and 4 = extremely. Total reaction scores range from 0 to 96 with higher scores indicating more bothered or upset by memory and behavior problems exhibited by the PLWD.
Measured: Baseline, Month 2, Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 20212 Sep 2022

First posted6 Jul 2021
Study start15 Sep 2021
Primary completion2 Sep 2022
Study completion2 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DementiaStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04951037
Sponsor's protocol ID: STUDY00000749
Other IDs: 3P30AG064200-02S1
Status last verified: Mar 2024
First submitted: 28 Jun 2021
Last updated: 16 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All of the individual participant data collected during the trial will be made available for sharing with other researchers, after deidentification.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Producing a Fully Asynchronous Online Savvy Program
ClinicalTrials.gov ID: NCT04951037
Acronym / sponsor ID: STUDY00000749
Conditions: Dementia
Keywords: Dementia caregiver
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 15 Sep 2021 (actual)
Primary completion: 2 Sep 2022 (actual)
Study completion: 2 Sep 2022 (actual)
First posted: 6 Jul 2021 (actual)
Results: Posted 16 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Fully Asynchronous Online Savvy Program	Experimental	Behavioral: Fully Asynchronous Online Savvy ProgramFamily caregivers of PLWD taking part in a fully asynchronous online caregiver education program.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

primary unpaid caregiver for a community-dwelling PLWD
provide at least 10 hours of direct care per week
able to read and understand English
be able to access the course online
naïve to Savvy or Tele-Savvy

Key exclusion criteria (4 listed)

cannot provide consent
prisoners
cognitively impaired adult
not able to clearly understand English

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fully Asynchronous Online Savvy ProgramAlso: Tele-SavvyThe intervention is a fully online, self-administered psychoeducational program designed to enhance caregiver mastery for family and friends providing unpaid care for living with Alzheimer's and similar dementia disorders. Participants will be asked to engage with a fully online version of Tele-Savvy for 42 days. Participants will receive a series of daily video lessons related to caregiving. These lessons are generally 8-15 minutes in length and are emailed to participants. Participants can watch the lessons whenever and as often as they wish over the course of the study. There will also be self-guided learning strategies and exercises to accomplish skill and mastery related to the caregiving role. The lessons cover a variety of topics including: * Facts about dementing Illnesses * Caregiving Strategies - guiding the person through days that are as safe, calm, and pleasant as possible * Self-Care for the Caregiver	Behavioural	Fully Asynchronous Online Savvy Program

Primary outcome

Center for Epidemiologic Studies - Depression (CES-D) Score
Time frame: Baseline, Month 2, Month 3
The CES-D is a 20-item self-report instrument asking respondents if they have experienced symptoms of depression during the past week. Responses are given on a scale of 0 to 3 where "rarely" = 0 and "most of the time" = 3. Total scores range from 0 to 60 and higher scores indicate greater symptoms of depression.
Zarit Burden Interview Score
Time frame: Baseline, Month 2, Month 3
The Zarit Burden Interview is a 22-item scale of objective and subjective caregiver burden. Responses are given on a 5-point scale where 0 = never and 4 = nearly always. Total scores range from 0 to 88 where higher scores indicate greater feelings of being burdened with providing care.
State-Trait Anxiety Inventory (STAI) Score
Time frame: Baseline, Month 2, Month 3
The STAI is a 20-item self-report scale of positive and negative anxiety experiences. Responses are given 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.
Caregiver Mastery Scale - Caregiving Competence Score
Time frame: Baseline, Month 2, Month 3
The Caregiving Mastery instrument assesses caregiver mastery of 3 different realms of caregiving situations: Relational Deprivation, Caregiving Competence, and Management of Situation. The Caregiving Competence subscale asks caregivers about their thoughts about the caregiving they provide with 4 items where responses are given on a 4-point scale where "not at all" = 1 and "completely" or "very" = 4. Total scores range from 4 to 16 where higher scores indicate greater feelings of competence with caregiving.
Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score
Time frame: Baseline, Month 2, Month 3
The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate how frequently problems have occurred on a 5-point scale where 0 = never occurred and 4 = daily or more often. Total frequency scores range from 0 to 96 with higher scores indicating greater frequency of memory and behavior problems exhibited by the PLWD.
Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score
Time frame: Baseline, Month 2, Month 3
The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate the degree to which problems have bothered or upset them on a 5-point scale where 0 = not at all and 4 = extremely. Total reaction scores range from 0 to 96 with higher scores indicating more bothered or upset by memory and behavior problems exhibited by the PLWD.

Results and safety

Results posted to the registry on 16 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fully Asynchronous Online Savvy Program	60	29

Primary outcome: Center for Epidemiologic Studies - Depression (CES-D) Score

Time frame: Baseline, Month 2, Month 3. Mean (Standard Deviation). Unit: score on a scale

Measure	Fully Asynchronous Online Savvy Program n = 60
Baseline among those who completed the Online Savvy Program	11.483 (11.009)
Month 2 among those who completed the Online Savvy Program	9.345 (6.360)
Month 3 among those who completed the Online Savvy Program	8.964 (8.149)
Baseline among those who completed the survey	14.317 (11.058)
Month 2 among those who completed the survey	10.848 (8.200)
Month 3 among those who completed the survey	10.132 (8.612)

Population analysed: This analysis includes values for the subset of 29 participants who completed the study intervention and the study assessments. Some participants did not complete the study intervention according to study timelines, but they did remain in the study and complete the assessments. In order to report all available data, values are also included for all study participants who completed the survey at the indicated time points, regardless of whether they completed the intervention.

Primary outcome: Zarit Burden Interview Score

Time frame: Baseline, Month 2, Month 3. Mean (Standard Deviation). Unit: score on a scale

Measure	Fully Asynchronous Online Savvy Program n = 60
Baseline among those who completed the Online Savvy Program	31.207 (12.957)
Month 2 among those who completed the Online Savvy Program	29.138 (10.395)
Month 3 among those who completed the Online Savvy Program	26.296 (9.474)
Baseline among those who completed the survey	35.050 (14.274)
Month 2 among those who completed the survey	31.239 (10.754)
Month 3 among those who completed the survey	28.730 (10.235)

Primary outcome: State-Trait Anxiety Inventory (STAI) Score

Time frame: Baseline, Month 2, Month 3. Mean (Standard Deviation). Unit: score on a scale

Measure	Fully Asynchronous Online Savvy Program n = 60
Baseline among those who completed the Online Savvy Program	31.793 (9.777)
Month 2 among those who completed the Online Savvy Program	31.793 (8.104)
Month 3 among those who completed the Online Savvy Program	29.893 (8.230)
Baseline among those who completed the survey	34.862 (11.190)
Month 2 among those who completed the survey	31.761 (9.053)
Month 3 among those who completed the survey	31.103 (9.167)

Primary outcome: Caregiver Mastery Scale - Caregiving Competence Score

Time frame: Baseline, Month 2, Month 3. Mean (Standard Deviation). Unit: score on a scale

Measure	Fully Asynchronous Online Savvy Program n = 52
Baseline among those who completed the Online Savvy Program	12.160 (1.700)
Month 2 among those who completed the Online Savvy Program	12.821 (1.945)
Month 3 among those who completed the Online Savvy Program	13.143 (2.085)
Baseline among those who completed the survey	11.481 (2.330)
Month 2 among those who completed the survey	12.689 (1.998)
Month 3 among those who completed the survey	13.026 (2.146)

Population analysed: Participants with incomplete responses were removed from this analysis. Of the 29 participants who completed the study intervention and assessments, 4 had missing responses for this survey at any time point, resulting in 25 participants analyzed. Values are also included for all study participants responding to surveys at the indicated time points, even if they did not complete the intervention; of these 8 had missing responses on this survey at Baseline and 1 had missing responses at Month 2.

Adverse events

Time frame: Information on adverse events was collected beginning when consent was given to participant in the study and continued through the final assessment at Month 3.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fully Asynchronous Online Savvy Program	0 of 60 (0%)	0 of 60 (0%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial will be made available for sharing with other researchers, after deidentification.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fayron Epps, PhD, RN principal investigator

Emory University

Carolyn Clevenger, DNP, RN principal investigator

Emory University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fully Asynchronous Online Savvy Program in people with Dementia, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Center for Epidemiologic Studies - Depression (CES-D) Score (time frame: Baseline, Month 2, Month 3). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04951037.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.