Daily Study of Caregiving Relationships and Health

Completed

• Conditions: Relations, Family; Relation, Interpersonal; Social Stress; Loneliness; Dementia of Alzheimer Type; Caregiver Burnout; Dementia
• Interventions: Other: Social relationships

• Registration Number: NCT04682535
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2020-12-18
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-23
• Primary Completion: 2021-05-17
• Status Verified: 2022-09
• Study Completion: 2022-09-01
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Social relationships	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.

Primary Outcome Measures

Name	Time	Method
Frequency of daily health symptoms	2 weeks	Frequency of adverse health symptoms experienced by participant (e.g., fatigue; 0 to 21)
Perceived sleep quality	2 weeks	Perceived sleep quality the night prior (1 to 5)
Physical activity	2 weeks	Participation in at least 30 minutes of moderate to vigorous physical activity (binary)
Potential binge eating behaviors	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)
Consumption of alcoholic beverages	2 weeks	Consumption of 1 or more alcoholic beverages (binary)

Secondary Outcome Measures

Name	Time	Method
Total salivary cortisol	2 weeks	Area under the curve score to approximate total cortisol output during the day (μg/dL)

Trial Locations

Locations (1)

UT Health San Antonio; 🇺🇸 San Antonio, Texas, United States