Caregiver BurnoutSoCalSavvyNCT04421729
SoCal Savvy: Testing Savvy Caregiver in a Racially and Ethnically Diverse Sample in Southern California
A study testing Group sessions over 3 weeks and Group sessions over 6 weeks in people with Caregiver Burnout and Psychological Distress, run by University of Southern California at 1 site in United States.
Trial summary
The investigators will conduct a hybrid efficacy-effectiveness trial intended to address these gaps by testing the efficacy-effectiveness of two multi-family group interventions, and on 250 English-speaking adults: Savvy Caregiver Express™ (3-session, newly piloted in Los Angeles County for feasibility) and Savvy… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burnout, Psychological Distress
- What is being tested?
- Group sessions over 3 weeks and Group sessions over 6 weeks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- English- speaking women and men age 18 or older who care for or provide assistance to someone with dementia
Who cannot join
- Caregivers who have sensory or physical conditions that interfere with participation in an on-site, group-administered activity
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90015
About this study
Official title: SoCal Savvy: Testing Savvy Caregiver in a Racially and Ethnically Diverse Sample in
The investigators will conduct a hybrid efficacy-effectiveness trial intended to address these gaps by testing the efficacy-effectiveness of two multi-family group interventions, and on 250 English-speaking adults: Savvy Caregiver Express™ (3-session, newly piloted in Los Angeles County for feasibility) and Savvy Caregiver Program (original 6-session evidenced-based intervention), across post-intervention, 3- and 6-months.
Read the detailed description
A number of epidemiological studies, systematic reviews, and consensus reports highlight the importance of non-pharmacological, sociobehavioural interventions to address the health, psychological, and social effects of caregiving for persons living with dementia, and the need for tangible information and resources.
The investigators will conduct a hybrid efficacy-effectiveness trial intended to address these gaps by testing the efficacy-effectiveness of two multi-family group interventions, and on 250 English-speaking adults: Savvy Caregiver Express™ (3-session, newly piloted in Los Angeles County for feasibility) and Savvy Caregiver Program (original 6-session evidenced-based intervention), across post-intervention, 3- and 6-months. It is hypothesized that no differences (comparable effects) between the programs in their efficacy/effectiveness and moderating conditions.
Focus groups (~25 participants) will be conducted to ascertain program acceptability and satisfaction.
The analyses will include a multiple linear mixed-effects modeling for our trial outcomes, and thematic analyses for our focus group interview data.
- Conditions
- Caregiver Burnout, Psychological Distress
- Being tested
- Group sessions over 3 weeks, Group sessions over 6 weeks
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group sessions over 3 weeksBehavioural
Informational and educational group-mediated program for family members caring for a person living with dementia; 6 sessions.
Group sessions over 6 weeksBehavioural
Informational and educational group-mediated program for family members caring for a person living with dementia; 3 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Savvy Caregiver Program | Active comparator | Savvy Caregiver Program, 6 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources. Receives: Behavioral: Group sessions over 6 weeks |
| Savvy Express | Active comparator | Savvy Express, 3 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources. Receives: Behavioral: Group sessions over 3 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
caregiver depressive symptoms
Measured: up to 7 months
Generalized Anxiety Disorder (GAD-7)
caregiver anxiety symptoms
Measured: up to 7 months
Revised Memory and Behavior Problems Checklist (RMBPC)
caregiver reactivity to family member's memory/behavior problems
Measured: up to 7 months
Secondary outcomes (5)
Caregiver Competence Scales
measures caregiver skills, mastery, competence, management of the situation based on the Caregiver Competence, Management and Meaning Scales
Measured: up to 7 months
Medical Outcomes Study Social Support Survey (MOS)
Measures caregiver social support using the MOS scale
Measured: up to 7 months
Intent to Institutionalize
TA one-item measure that assesses if the caregiver intends to institutionalize the family member in the next 6 months
Measured: up to 7 months
Family Members Activities of Daily Living (ADL)
measures family member's activities of daily living using the Katz ADL scale
Measured: up to 7 months
Family Members Instrumental Activities of Daily Living (IADL)
measures family member's activities of daily living using the Lawton IDL scale
Measured: up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start25 Aug 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurnoutStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria P. Aranda, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421729
- Sponsor's protocol ID
- 5356000538
- Acronym
- SoCalSavvy
- Status last verified
- May 2024
- First submitted
- 2 Jun 2020
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SoCal Savvy: Testing Savvy Caregiver in a Racially and Ethnically Diverse Sample in
- ClinicalTrials.gov ID
- NCT04421729
- Acronym / sponsor ID
- SoCalSavvy / 5356000538
- Conditions
- Caregiver Burnout, Psychological Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will conduct a hybrid efficacy-effectiveness trial intended to address these gaps by testing the efficacy-effectiveness of two multi-family group interventions, and on 250 English-speaking adults: Savvy Caregiver Express™ (3-session, newly piloted in Los Angeles County for feasibility) and Savvy Caregiver Program (original 6-session evidenced-based intervention), across post-intervention, 3- and 6-months.
Detailed description
A number of epidemiological studies, systematic reviews, and consensus reports highlight the importance of non-pharmacological, sociobehavioural interventions to address the health, psychological, and social effects of caregiving for persons living with dementia, and the need for tangible information and resources.
The investigators will conduct a hybrid efficacy-effectiveness trial intended to address these gaps by testing the efficacy-effectiveness of two multi-family group interventions, and on 250 English-speaking adults: Savvy Caregiver Express™ (3-session, newly piloted in Los Angeles County for feasibility) and Savvy Caregiver Program (original 6-session evidenced-based intervention), across post-intervention, 3- and 6-months. It is hypothesized that no differences (comparable effects) between the programs in their efficacy/effectiveness and moderating conditions.
Focus groups (~25 participants) will be conducted to ascertain program acceptability and satisfaction.
The analyses will include a multiple linear mixed-effects modeling for our trial outcomes, and thematic analyses for our focus group interview data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Savvy Caregiver Program | Active comparator | Behavioral: Group sessions over 6 weeksSavvy Caregiver Program, 6 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources. |
| Savvy Express | Active comparator | Behavioral: Group sessions over 3 weeksSavvy Express, 3 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English- speaking women and men age 18 or older who care for or provide assistance to someone with dementia
Key exclusion criteria (1 listed)
- Caregivers who have sensory or physical conditions that interfere with participation in an on-site, group-administered activity
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 |
|---|---|---|
| Group sessions over 3 weeksInformational and educational group-mediated program for family members caring for a person living with dementia; 6 sessions. | Behavioural | Savvy Express |
| Group sessions over 6 weeksInformational and educational group-mediated program for family members caring for a person living with dementia; 3 sessions. | Behavioural | Savvy Caregiver Program |
Primary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: up to 7 months
caregiver depressive symptoms
Generalized Anxiety Disorder (GAD-7)
Time frame: up to 7 months
caregiver anxiety symptoms
Revised Memory and Behavior Problems Checklist (RMBPC)
Time frame: up to 7 months
caregiver reactivity to family member's memory/behavior problems
5 secondary outcomes
Caregiver Competence Scales
Time frame: up to 7 months
Medical Outcomes Study Social Support Survey (MOS)
Time frame: up to 7 months
Intent to Institutionalize
Time frame: up to 7 months
Family Members Activities of Daily Living (ADL)
Time frame: up to 7 months
Family Members Instrumental Activities of Daily Living (IADL)
Time frame: up to 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group sessions over 3 weeks and Group sessions over 6 weeks in people with Caregiver Burnout and Psychological Distress, run by University of Southern California 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 1 inclusion and 1 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 3 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient Health Questionnaire-9 (PHQ-9) (time frame: up to 7 months). The study lists 3 primary outcomes in all. 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 3 Jun 2024.