Caregiver Stress SyndromeNCT04939714

Caregiving During Crisis

A study testing Psychoeducational Intervention in people with Caregiver Stress Syndrome, 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

Search all trials

Trial summary

This study will test a prototype pandemic caregiver training and education course designed for caregivers of persons living with dementia (PLWD). Participants will be randomized to take the course immediately or to take the course after completion of an 8-week waiting period. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Caregiver Stress Syndrome
What is being tested?: Psychoeducational Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 7 Jun 2021to 15 Aug 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

Providing care for a family member or friend with a confirmed diagnosis of dementia
Lives in the community
Co-resides with the PLWD
Is the main caregiver for the PLWD
Has access to a computer with internet service
Can read and understand English

Who cannot join

None

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

Official title: Mastering the Challenges of Dementia Family Caregiving in a Time of COVID-19: An Online Course

Read the detailed description

Family caregivers, the backbone of care for the upwards of 7 million community-dwelling individuals living with Alzheimer's disease in the U.S., provide at least 85% of the care these individuals receive, at some risk to their own well-being, and are instrumental in navigating healthcare systems. Without their care, it is almost certain that persons living with dementia (PLWD) would have much higher rates of acute and emergency care use than their age-matched peers, perilous venues for them in the best of times, potentially deadly during this pandemic. With coronavirus disease 2019 (COVID-19) restrictions, the amount of care they provide and the expertise needed to provide the care will increase. Typically, caregivers are strangers in healthcare and pandemic landscapes, but they are now called on to enact home care and safety measures and navigate an intricate, complex, and opaque system without the benefit of a compass or a translator, and largely without understanding their role in or having the skills for navigating the system. A variety of interventions have demonstrated benefit in enhancing caregivers' caregiving capacities, with resulting positive outcomes for both caregivers and care recipients. Only a few of these useful interventions, Tele-Savvy among them, have employed distance delivery means, thus enabling rural caregivers and others precluded by circumstance from attending in-person programs to take part in the intervention programs.

The study will assess a psychoeducational intervention for dementia caregivers. Participating caregivers will be randomized to immediately enroll in the study intervention or to be in a waitlist group that will begin the intervention 8 weeks later. Participants will complete interviews at baseline and after the 8-week study period.

Conditions: Caregiver Stress Syndrome
Being tested: Psychoeducational Intervention
Keywords: Dementia family caregiver, Online education

What participants receive

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

Psychoeducational InterventionBehavioural
The intervention is an online course providing education and training to caregivers over an 8 week period. The self-paced course provides information on caregiving for a PLWD during a pandemic, navigating the health care system for a PLWD, and managing daily life (including self-care).

Study groups in NCT04939714
Study group	Role	What they receive
Psychoeducational Intervention	Experimental	Caregivers receiving the psychoeducational intervention immediately. Receives: Behavioral: Psychoeducational Intervention
Waitlist	No intervention	Caregivers on a waitlist to receive the psychoeducational intervention after a waiting period of 8 weeks.

What is being measured

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

Center for Epidemiologic Studies - Depression (CES-D) Scale 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 is scored as 0 and most of the time is scored as 3. Total scores range from 0 to 60 and higher scores indicate greater symptoms of depression.
Measured: Baseline, Week 8
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, Week 8
Perceived Stress Scale (PSS-14) Score
The Perceived Stress Scale includes 14 items assessing self-reported caregiving stress. Responses are given on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 56 and higher values indicate greater perceived stress.
Measured: Baseline, Week 8
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 person living with dementia (PLWD).
Measured: Baseline, Week 8
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, Week 8
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, Week 8
Caregiver Mastery Scales - Competency 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 section includes 4 items are responded to on a 4-point scale where 1 = not at all and 4 = completely. Total scores range from 4 to 16 where higher scores indicate greater feelings of mastery of caregiving.
Measured: Baseline, Week 8
Caregiver Assessment of Behavioral Skill - Self-report Score
The Caregiver Assessment of Behavioral Skill - Self-report instrument is a 17-item caregiver self-assessment of perceived capacity to manage care situations. Responses are given on a 3-point scale where 0 = seldom true and 3 = true most of the time, for behaviors exhibited by or relevant to the PLWD. Total scores range from 0 to 51 where higher scores indicate perceived ability to manage providing care.
Measured: Baseline, Week 8

Timeline

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

7 Jun 202115 Aug 2022

First posted25 Jun 2021
Study start7 Jun 2021
Primary completion15 Aug 2022
Study completion15 Aug 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 Caregiver Stress SyndromeStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04939714
Sponsor's protocol ID: STUDY00001424
Other IDs: 3P30AG064200-02S1
Status last verified: Mar 2024
First submitted: 17 Jun 2021
Last updated: 4 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, 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

Recruiting
Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial
Neurofibromatosis 1, Noonan Syndrome
Not yet recruitingObservational study
Patients With Long-stay at ICU: Factors and Evaluation - Feasibility Study
Frailty, Delirium Confusional State
RecruitingObservational study
Teleneurology Assessment Program for Creutzfeldt-Jakob Disease
Creutzfeldt-Jakob Disease (CJD) | Prion Disease
Not yet recruiting
Effectiveness of Stress Management Training in Reducing Caregiver Burden and Perceived Stress in ICU Families
Intensive Care Unit Syndrome, Critical Illness
RecruitingObservational study
Assessment of Cancer-related Post-traumatic Stress in Patients and Caregivers in the Year Following Diagnosis, and Identification of Their Expectations of Personalized Support - CANDYSTRESS
Cancer, Healthcare Professionnals

All Caregiver Stress Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mastering the Challenges of Dementia Family Caregiving in a Time of COVID-19: An Online Course
ClinicalTrials.gov ID: NCT04939714
Acronym / sponsor ID: STUDY00001424
Conditions: Caregiver Stress Syndrome
Keywords: Dementia family caregiver, Online education
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 7 Jun 2021 (actual)
Primary completion: 15 Aug 2022 (actual)
Study completion: 15 Aug 2022 (actual)
First posted: 25 Jun 2021 (actual)
Results: Posted 4 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Psychoeducational Intervention	Experimental	Behavioral: Psychoeducational InterventionCaregivers receiving the psychoeducational intervention immediately.
Waitlist	No intervention	–Caregivers on a waitlist to receive the psychoeducational intervention after a waiting period of 8 weeks.

Who may qualify

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

Key inclusion criteria (6 listed)

Providing care for a family member or friend with a confirmed diagnosis of dementia
Lives in the community
Co-resides with the PLWD
Is the main caregiver for the PLWD
Has access to a computer with internet service

Key exclusion criteria (1 listed)

None

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
Psychoeducational InterventionThe intervention is an online course providing education and training to caregivers over an 8 week period. The self-paced course provides information on caregiving for a PLWD during a pandemic, navigating the health care system for a PLWD, and managing daily life (including self-care).	Behavioural	Psychoeducational Intervention

Primary outcome

Center for Epidemiologic Studies - Depression (CES-D) Scale Score
Time frame: Baseline, Week 8
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 is scored as 0 and most of the time is scored as 3. Total scores range from 0 to 60 and higher scores indicate greater symptoms of depression.
State-Trait Anxiety Inventory (STAI) Score
Time frame: Baseline, Week 8
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.
Perceived Stress Scale (PSS-14) Score
Time frame: Baseline, Week 8
The Perceived Stress Scale includes 14 items assessing self-reported caregiving stress. Responses are given on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 56 and higher values indicate greater perceived stress.
Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score
Time frame: Baseline, Week 8
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 person living with dementia (PLWD).
Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score
Time frame: Baseline, Week 8
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.
Zarit Burden Interview Score
Time frame: Baseline, Week 8
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.
Caregiver Mastery Scales - Competency Score
Time frame: Baseline, Week 8
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 section includes 4 items are responded to on a 4-point scale where 1 = not at all and 4 = completely. Total scores range from 4 to 16 where higher scores indicate greater feelings of mastery of caregiving.
Caregiver Assessment of Behavioral Skill - Self-report Score
Time frame: Baseline, Week 8
The Caregiver Assessment of Behavioral Skill - Self-report instrument is a 17-item caregiver self-assessment of perceived capacity to manage care situations. Responses are given on a 3-point scale where 0 = seldom true and 3 = true most of the time, for behaviors exhibited by or relevant to the PLWD. Total scores range from 0 to 51 where higher scores indicate perceived ability to manage providing care.

Results and safety

Results posted to the registry on 4 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
Psychoeducational Intervention Immediately	50	33
Psychoeducational Intervention After Waiting Period	50	30

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

Time frame: Baseline, Week 8. Mean (Standard Deviation). Unit: score on a scale

Measure	Psychoeducational Intervention n = 50	Waitlist Control Group n = 50
Baseline	11.7 (8.8)	11.8 (8.0)
Week 8	10.4 (8.7)	14.6 (9.6)

Population analysed: This analysis includes participants who attended the indicated study visits.

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

Time frame: Baseline, Week 8. Mean (Standard Deviation). Unit: score on a scale

Measure	Psychoeducational Intervention n = 50	Waitlist Control Group n = 50
Baseline	29.7 (8.5)	33.7 (9.1)
Week 8	32.6 (10.4)	38.2 (12.5)

Population analysed: This analysis includes participants who attended the indicated study visits and who provided complete information for the survey.

Primary outcome: Perceived Stress Scale (PSS-14) Score

Time frame: Baseline, Week 8. Mean (Standard Deviation). Unit: score on a scale

Measure	Psychoeducational Intervention n = 50	Waitlist Control Group n = 50
Baseline	22.3 (7.9)	22.4 (7.3)
Week 8	21.7 (7.1)	23.1 (8.1)

Population analysed: This analysis includes participants who attended the indicated study visits.

Primary outcome: Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score

Time frame: Baseline, Week 8. Mean (Standard Deviation). Unit: score on a scale

Measure	Psychoeducational Intervention n = 50	Waitlist Control Group n = 50
Baseline	39.3 (11.0)	40.1 (12.4)
Week 8	39.0 (11.8)	38.2 (13.4)

Population analysed: This analysis includes participants who attended the indicated study visits and who provided complete information for the survey.

Adverse events

Time frame: Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 16.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Psychoeducational Intervention Immediately	0 of 50 (0%)	0 of 50 (0%)	0 of 50
Psychoeducational Intervention After Waiting Period	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 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, after deidentification.

Related trials for Caregiver Stress Syndrome

Recruiting
Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial
Neurofibromatosis 1, Noonan Syndrome
Not yet recruitingObservational study
Patients With Long-stay at ICU: Factors and Evaluation - Feasibility Study
Frailty, Delirium Confusional State
RecruitingObservational study
Teleneurology Assessment Program for Creutzfeldt-Jakob Disease
Creutzfeldt-Jakob Disease (CJD) | Prion Disease
Not yet recruiting
Effectiveness of Stress Management Training in Reducing Caregiver Burden and Perceived Stress in ICU Families
Intensive Care Unit Syndrome, Critical Illness
RecruitingObservational study
Assessment of Cancer-related Post-traumatic Stress in Patients and Caregivers in the Year Following Diagnosis, and Identification of Their Expectations of Personalized Support - CANDYSTRESS
Cancer, Healthcare Professionnals

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.

Carolyn Clevenger, DNP, APRN 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 Psychoeducational Intervention in people with Caregiver Stress Syndrome, 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 6 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 4 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 4 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) Scale Score (time frame: Baseline, Week 8). The study lists 8 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 NCT04939714.

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 4 Apr 2024.