Caregiver BurnoutNCT04060355
Savvy System Project
A study testing Savvy program and Semi-structured video interviews in people with Caregiver Burnout and Dementia, run by Emory University at 1 site in United States.
Trial summary
The study goal is to develop a web-based system that uses distance education methods and provides manuals and protocols to train, certify, and monitor the performance of interventionists to deliver the Savvy Caregiver program (Savvy), an evidence-based dementia family caregiver psychoeducation program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Burnout, Dementia
- What is being tested?
- Savvy program and Semi-structured video interviews
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2021to 31 Oct 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Organizational Leaders
- Able to understand and speak English
- Affiliated with an organization serving caregivers for family members living with Alzheimer's disease or related dementias
- 18 years or older
- Interventionists
- Able to understand and speak English
Show all 12Show fewer
- Affiliated with a participating organization
- 18 years or older
- Caregivers
- Able to understand and speak English
- Caregiver for a person living with Alzheimer's disease or related dementias (PLWD) who is providing informal care for at least 3 hours a day. PLWD should not be bound for institutional care within the next 6 months.
- 18 years or older
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing a Distance Education System to Train Savvy Caregiver Program Interventionists: Extending Access and Capacity in Community-Based Delivery of Evidence-Based Interventions
The study goal is to develop a web-based system that uses distance education methods and provides manuals and protocols to train, certify, and monitor the performance of interventionists to deliver the Savvy Caregiver program (Savvy), an evidence-based dementia family caregiver psychoeducation program. The system has a potential to increase the scalability of Savvy.
Read the detailed description
The number of People Living With Disability (PLWD) in the U.S. will rise from 5.7 million to 14 million by 2050, and the number of family caregivers who maintain these persons in the community will rise proportionately from 15 million at present. Several psychoeducation programs, including Savvy, have successfully ameliorated the adverse effects of caregiving, but these programs are only minimally available and accessible.
The study goal is to develop a web-based system that uses distance education methods and provides manuals and protocols to train, certify, and monitor the performance of interventionists to deliver the Savvy Caregiver program (Savvy), an evidence-based dementia family caregiver psychoeducation program. The system has a potential to increase the scalability of Savvy.
- Conditions
- Caregiver Burnout, Dementia
- Being tested
- Savvy program, Semi-structured video interviews
- Keywords
- People Living With Disability, PLWD, Caregiver, Interventionist, Distance education, Savvy
- Medical subject headings
- Caregiver Burden, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Savvy programBehavioural
Caregiver program (Savvy) is an evidence-based dementia family caregiver psychoeducation program. Provided to groups of 8-12 (typically) individuals caring for family members living with Alzheimer's disease or related dementias (PLWD), Savvy employs a mechanism of action based in Social Cognitive theory to promote caregivers' solution-focused coping behaviors through the acquisition of appropriate knowledge, skills, and outlook and the enhancement of caregiving mastery.
Semi-structured video interviewsBehavioural
Semi-structured video interviews will assess the preliminary efficacy of programs led by system-trained interventionists in producing anticipated outcomes in caregiver participants - reduced depression and burden and enhanced caregiving mastery. It will also focus on sense of the completeness and adequacy of the training program, including the training methods, videos, and materials
| Study group | Role | What they receive |
|---|---|---|
| Savvy Participants | Experimental | Using an on-line survey method, each caregiver will be asked to complete the post-program fidelity monitoring survey that seeks responses to the program (feel more knowledgeable, more competent, better equipped, etc.) and asks them to assess the interventionist's performance and verify that certain key elements of the program were covered. Receives: Behavioral: Savvy program |
| Interventionists | Experimental | Three recorded semi-structured video interviews will be conducted with each interventionist. One will occur immediately after training; this will focus on their sense of the completeness and adequacy of the training program, including the training methods, videos, and materials, and their perceived readiness to lead the program. Another interview will be done immediately after the conduct of each of the two Savvy programs they lead, asking them to report on their performance as interventionists, including any adaptation processes in which they might have engaged, and to reflect on ways the training might be improved to strengthen their skills, including for adaptation. Receives: Behavioral: Semi-structured video interviews |
| Organizational Leaders | Experimental | Recorded semi-structured video interviews with sponsoring organizations' key contact persons will be conducted immediately after the interventionist training and then after each of the two Savvy offerings. The conversation will focus on identifying ways to strengthen and improve the training, certification, and fidelity monitoring system. Information about time and resource costs of the program, caregiver demand, and caregiver recruitment and feedback will be also collected. Receives: Behavioral: Semi-structured video interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) Score
The CES-D scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past week. It includes 20 items comprising six scales reflecting major facets of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Measured: Baseline, Month 6
Secondary outcomes (4)
Change in Anxiety Score
State-Trait Anxiety Inventory scale - 20-item 4-point Likert scale is sensitive to changes in transitory anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" (0) to "Almost Always" (3)); Range: 0-60. Higher scores indicate greater anxiety.
Measured: Baseline, Month 6
Change in Zarit Burden Inventory (ZBI) Score
Zarit Burden Inventory (ZBI) score is a 22-item Likert scale. Each item is a statement which the caregiver is asked to endorse using a 5-point scale, scored "Never" (0) to "Nearly Always" (4); Range: 0-88. Total score is obtained by summing all items endorsed. Higher scores indicate greater perceived burden.
Measured: Baseline, Month 6
Change in Caregiver Pearlin Mastery Score
The Pearlin Mastery (PM) scale measures the extent to which an individual regards their life chances as being under their personal control rather than fatalistically ruled. Response options: 4-point Likert scale, 1,"Strongly disagree" and 4,"Strongly agree". Items are summed, yielding a range from 7 to 28. Higher scores indicate greater levels of mastery.
Measured: Baseline, Month 6
Change in Revised Memory and Behavior Problem Checklist Score
Revised Memory and Behavior Problem Checklist is a 24-item two-part Likert scale that assesses (Part 1) caregiver reported frequency of patient behaviors and (Part 2) caregiver's responreaction to each behavior, or the extent of distress experienced. The frequency of behaviors is assessed based on a Likert-scale of 0 to (0 = never occurs, 1 = occurs infrequently and not in the last week, 2 = occurred 1-2 times in the last week, 3 = occurred 3-6 times in the last week, and 4 = occurs daily or more often); Range: 0-96. Reactions are assessed by asking how" upsetting" the behavior was on a Likert scale of 0 to 4 (0 = Not at all, 1= a little, 2 = moderately, 3 = very much, and 4 =extremely); Range: 0-96. The two parts of the scale yield a summary score - higher scores indicate higher frequency of patient behaviors and greater levels of caregiver distress, respectively.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start4 Aug 2021
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
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 Caregiver BurnoutStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Kenneth Hepburn, Emory University
- Investigators
- Kenneth Hepburn, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060355
- Sponsor's protocol ID
- IRB00108423
- Other IDs
- R01AG061971
- Status last verified
- Dec 2024
- First submitted
- 15 Aug 2019
- Last updated
- 30 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after de-identification
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Distance Education System to Train Savvy Caregiver Program Interventionists: Extending Access and Capacity in Community-Based Delivery of Evidence-Based Interventions
- ClinicalTrials.gov ID
- NCT04060355
- Acronym / sponsor ID
- IRB00108423
- Conditions
- Caregiver Burnout, Dementia
- Keywords
- People Living With Disability, PLWD, Caregiver, Interventionist, Distance education, Savvy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 19 Aug 2019 (actual)
- Results
- Posted 3 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study goal is to develop a web-based system that uses distance education methods and provides manuals and protocols to train, certify, and monitor the performance of interventionists to deliver the Savvy Caregiver program (Savvy), an evidence-based dementia family caregiver psychoeducation program. The system has a potential to increase the scalability of Savvy.
Detailed description
The number of People Living With Disability (PLWD) in the U.S. will rise from 5.7 million to 14 million by 2050, and the number of family caregivers who maintain these persons in the community will rise proportionately from 15 million at present. Several psychoeducation programs, including Savvy, have successfully ameliorated the adverse effects of caregiving, but these programs are only minimally available and accessible.
The study goal is to develop a web-based system that uses distance education methods and provides manuals and protocols to train, certify, and monitor the performance of interventionists to deliver the Savvy Caregiver program (Savvy), an evidence-based dementia family caregiver psychoeducation program. The system has a potential to increase the scalability of Savvy.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Savvy Participants | Experimental | Behavioral: Savvy programUsing an on-line survey method, each caregiver will be asked to complete the post-program fidelity monitoring survey that seeks responses to the program (feel more knowledgeable, more competent, better equipped, etc.) and asks them to assess the interventionist's performance and verify that certain key elements of the program were covered. |
| Interventionists | Experimental | Behavioral: Semi-structured video interviewsThree recorded semi-structured video interviews will be conducted with each interventionist. One will occur immediately after training; this will focus on their sense of the completeness and adequacy of the training program, including the training methods, videos, and materials, and their perceived readiness to lead the program. Another interview will be done immediately after the conduct of each of the two Savvy programs they lead, asking them to report on their performance as interventionists, including any adaptation processes in which they might have engaged, and to reflect on ways the training might be improved to strengthen their skills, including for adaptation. |
| Organizational Leaders | Experimental | Behavioral: Semi-structured video interviewsRecorded semi-structured video interviews with sponsoring organizations' key contact persons will be conducted immediately after the interventionist training and then after each of the two Savvy offerings. The conversation will focus on identifying ways to strengthen and improve the training, certification, and fidelity monitoring system. Information about time and resource costs of the program, caregiver demand, and caregiver recruitment and feedback will be also collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Organizational Leaders
- Able to understand and speak English
- Affiliated with an organization serving caregivers for family members living with Alzheimer's disease or related dementias
- 18 years or older
- Interventionists
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Savvy programCaregiver program (Savvy) is an evidence-based dementia family caregiver psychoeducation program. Provided to groups of 8-12 (typically) individuals caring for family members living with Alzheimer's disease or related dementias (PLWD), Savvy employs a mechanism of action based in Social Cognitive theory to promote caregivers' solution-focused coping behaviors through the acquisition of appropriate knowledge, skills, and outlook and the enhancement of caregiving mastery. | Behavioural | Savvy Participants |
| Semi-structured video interviewsSemi-structured video interviews will assess the preliminary efficacy of programs led by system-trained interventionists in producing anticipated outcomes in caregiver participants - reduced depression and burden and enhanced caregiving mastery. It will also focus on sense of the completeness and adequacy of the training program, including the training methods, videos, and materials | Behavioural | Interventionists, Organizational Leaders |
Primary outcome
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) Score
Time frame: Baseline, Month 6
The CES-D scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past week. It includes 20 items comprising six scales reflecting major facets of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
4 secondary outcomes
Change in Anxiety Score
Time frame: Baseline, Month 6
Change in Zarit Burden Inventory (ZBI) Score
Time frame: Baseline, Month 6
Change in Caregiver Pearlin Mastery Score
Time frame: Baseline, Month 6
Change in Revised Memory and Behavior Problem Checklist Score
Time frame: Baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 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, after de-identification
Related trials for Caregiver Burnout
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Peer Support for Family Caregivers of Older Adults Living With Dementia
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Enrolling by invitation
Evaluation of the CBSM Program Online and in Person to Reduce Caregiver Burnout
Burnout, Caregiver
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Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
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Feasibility of Body Acupuncture for Stress, Burnout, Sleep Quality and Wellbeing: A Pilot Study
Occupational Stress or Workplace Stress, Exhaustion, Caregiver
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Caregiver Burden, Caregiver Burnout
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.
Kenneth Hepburn, PhD 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 Savvy program and Semi-structured video interviews in people with Caregiver Burnout and 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 12 inclusion and 0 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 30 Dec 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 3 Dec 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?
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) Score (time frame: Baseline, Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2024.