Caregiver BurnoutNCT04682535
Daily Study of Caregiving Relationships and Health
An observational study of Caregiver Burnout and Dementia, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The purpose of the Daily Study of Caregiving Relationships and Health is to learn how caregiving relationships and social connectedness are associated with dementia caregivers' health, health behaviors, and diurnal patterns of salivary cortisol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Burnout, Dementia, Dementia of Alzheimer Type
- What is being tested?
- Social relationships
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 1 Sep 2022
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Spousal family caregivers to persons diagnosed with dementia (any type)
Who may be able to join
- Spouse or partner to an individual living with ADRD who has received a diagnosis from a physician
- Aged 18 years or older Provides assistance with at least one instrumental activities of daily living or activities of daily living
- Not paid to provide care
- Cares for someone with a global deterioration score of 1 to 5 (early to mid-stage dementia)
- Has reliable access to email and text messaging, and smart phone device
- Live within 40 miles of UT Health San Antonio (if completing saliva collection protocol)
Who cannot join
- Inability to read and speak English or Spanish
- Vision or hearing impairment affecting ability to complete study protocols (e.g., blindness)
- Additional exclusion Criteria if completing saliva collection protocol:
- Experiencing a major health event within the previous 6 months (e.g., stroke, myocardial infarction, in-patient surgery, cancer besides skin cancer)
- Symptoms of infectious disease within the previous 14-days (e.g., COVID-19, oral infection)
- Diagnosis of major depressive disorder
Show all 10Show fewer
- HPA axis endocrine disorder (e.g., Cushings or Addison's disease)
- Use of corticosteroid medication
- Pregnancy
- Participation in overnight shift work
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the Daily Study of Caregiving Relationships and Health is to learn how caregiving relationships and social connectedness are associated with dementia caregivers' health, health behaviors, and diurnal patterns of salivary cortisol.
This is a pilot study wherein the purpose is to test the feasibility and acceptability of study protocols.
Read the detailed description
The purpose of the Daily Study of Caregiving Relationships and Health is to learn how caregiving relationships and social connectedness are associated with dementia caregivers' health, health behaviors, and diurnal patterns of salivary cortisol. Investigators are asking caregivers to complete 14-days of surveys which ask about their relationships and health behaviors, in addition to 2 longer surveys (baseline and 3-month follow up). Investigators hypothesize that on days when caregivers receive more emotional support, they will report better health behaviors (e.g., improved sleep quality). On days when caregivers experience greater 1) strain and 2) loneliness, they will report poorer health behaviors. Information about which aspects of social relationships and social connectedness most affect health will be used to inform interventions programs.
- Conditions
- Caregiver Burnout, Dementia, Dementia of Alzheimer Type, Relations, Family, Social Stress, Relation, Interpersonal
- Being tested
- Social relationships
- 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.
Social relationshipsOther
Exposure to social interactions with spouse, friends, and family. Perceived loneliness, emotional strain, and emotional support.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Spousal/partner family caregivers to persons living with dementia. Participants will complete 14-days of surveys about their relationships, social interactions, as well as health and health behaviors. A subsample of n=15 may volunteer to provide diurnal saliva samples. Receives: Other: Social relationships |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of daily health symptoms
Frequency of adverse health symptoms experienced by participant (e.g., fatigue; 0 to 21)
Measured: 2 weeks
Perceived sleep quality
Perceived sleep quality the night prior (1 to 5)
Measured: 2 weeks
Physical activity
Participation in at least 30 minutes of moderate to vigorous physical activity (binary)
Measured: 2 weeks
Consumption of alcoholic beverages
Consumption of 1 or more alcoholic beverages (binary)
Measured: 2 weeks
Potential binge eating behaviors
Frequency of binge eating behaviors, including consuming unusually large amount of food, feeling out of control, and unplanned and repetitive eating (0 to 33)
Measured: 2 weeks
Secondary outcomes (1)
Total salivary cortisol
Area under the curve score to approximate total cortisol output during the day (μg/dL)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start1 Sep 2020
- Primary completion17 May 2021
- Study completion1 Sep 2022
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.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682535
- Sponsor's protocol ID
- HSC20200421H
- Status last verified
- Sep 2022
- First submitted
- 18 Dec 2020
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD used for publication will be available by contacting (i.e., emailing) the PI. Supporting materials available upon request and at PI's discretion.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Study of Caregiving Relationships and Health
- ClinicalTrials.gov ID
- NCT04682535
- Acronym / sponsor ID
- HSC20200421H
- Conditions
- Caregiver Burnout, Dementia, Dementia of Alzheimer Type, Relations, Family, Social Stress, Relation, Interpersonal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 23 Dec 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 purpose of the Daily Study of Caregiving Relationships and Health is to learn how caregiving relationships and social connectedness are associated with dementia caregivers' health, health behaviors, and diurnal patterns of salivary cortisol.
This is a pilot study wherein the purpose is to test the feasibility and acceptability of study protocols.
Detailed description
The purpose of the Daily Study of Caregiving Relationships and Health is to learn how caregiving relationships and social connectedness are associated with dementia caregivers' health, health behaviors, and diurnal patterns of salivary cortisol. Investigators are asking caregivers to complete 14-days of surveys which ask about their relationships and health behaviors, in addition to 2 longer surveys (baseline and 3-month follow up). Investigators hypothesize that on days when caregivers receive more emotional support, they will report better health behaviors (e.g., improved sleep quality). On days when caregivers experience greater 1) strain and 2) loneliness, they will report poorer health behaviors. Information about which aspects of social relationships and social connectedness most affect health will be used to inform interventions programs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Social relationshipsSpousal/partner family caregivers to persons living with dementia. Participants will complete 14-days of surveys about their relationships, social interactions, as well as health and health behaviors. A subsample of n=15 may volunteer to provide diurnal saliva samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Spousal family caregivers to persons diagnosed with dementia (any type)
Key inclusion criteria (6 listed)
- Spouse or partner to an individual living with ADRD who has received a diagnosis from a physician
- Aged 18 years or older Provides assistance with at least one instrumental activities of daily living or activities of daily living
- Not paid to provide care
- Cares for someone with a global deterioration score of 1 to 5 (early to mid-stage dementia)
- Has reliable access to email and text messaging, and smart phone device
Key exclusion criteria (10 listed)
- Inability to read and speak English or Spanish
- Vision or hearing impairment affecting ability to complete study protocols (e.g., blindness)
- Experiencing a major health event within the previous 6 months (e.g., stroke, myocardial infarction, in-patient surgery, cancer besides skin cancer)
- Symptoms of infectious disease within the previous 14-days (e.g., COVID-19, oral infection)
- Diagnosis of major depressive disorder
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 |
|---|---|---|
| Social relationshipsExposure to social interactions with spouse, friends, and family. Perceived loneliness, emotional strain, and emotional support. | Other | Cohort 1 |
Primary outcome
Frequency of daily health symptoms
Time frame: 2 weeks
Frequency of adverse health symptoms experienced by participant (e.g., fatigue; 0 to 21)
Perceived sleep quality
Time frame: 2 weeks
Perceived sleep quality the night prior (1 to 5)
Physical activity
Time frame: 2 weeks
Participation in at least 30 minutes of moderate to vigorous physical activity (binary)
Consumption of alcoholic beverages
Time frame: 2 weeks
Consumption of 1 or more alcoholic beverages (binary)
Potential binge eating behaviors
Time frame: 2 weeks
Frequency of binge eating behaviors, including consuming unusually large amount of food, feeling out of control, and unplanned and repetitive eating (0 to 33)
1 secondary outcome
Total salivary cortisol
Time frame: 2 weeks
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 16 Sep 2022.
- Individual participant dataSharing planned: Yes. De-identified IPD used for publication will be available by contacting (i.e., emailing) the PI. Supporting materials available upon request and at PI's discretion.
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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?
An observational study of Caregiver Burnout and Dementia, run by The University of Texas Health Science Center at San Antonio 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 10 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 Sep 2022. 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?
Frequency of daily health symptoms (time frame: 2 weeks). The study lists 5 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 16 Sep 2022.