Clinical trial NCT04682535: Daily Study of Caregiving Relationships and Health
Official title: Daily Study of Caregiving Relationships and Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Caregiver Burnout
Dementia
Dementia of Alzheimer Type
Relations, Family
Social Stress
Relation, Interpersonal
Loneliness
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spousal family caregivers to persons diagnosed with dementia (any type)

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* HPA axis endocrine disorder (e.g., Cushings or Addison's disease)
* Use of corticosteroid medication
* Pregnancy
* Participation in overnight shift work

Primary outcomes:
measure: Frequency of daily health symptoms
timeFrame: 2 weeks
measure: Perceived sleep quality
timeFrame: 2 weeks
measure: Physical activity
timeFrame: 2 weeks
measure: Consumption of alcoholic beverages
timeFrame: 2 weeks
measure: Potential binge eating behaviors
timeFrame: 2 weeks
Secondary outcomes:
measure: Total salivary cortisol
timeFrame: 2 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: UT Health San Antonio
state: Texas
Study officials:
References: