Daily Study of Caregiving Relationships and Health

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Loneliness; Dementia of Alzheimer Type; Caregiver Burnout; Social Stress; Relation, Interpersonal; Relations, Family
• Intervention / Treatment: Other: Social relationships

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 Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • UT Health San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Spousal family caregivers to persons diagnosed with dementia (any type)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Social relationships; Exposure to social interactions with spouse, friends, and family. Perceived loneliness, emotional strain, and emotional support.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total salivary cortisol	Area under the curve score to approximate total cortisol output during the day (μg/dL)	2 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): May 17, 2021
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Stress, Psychological; Tauopathies; Dementia; Alzheimer Disease; Caregiver Burden
• Other Study ID Numbers: HSC20200421H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: IPD available following publication of peer-reviewed manuscripts and made available to peer-reviewers upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No