Daily Study of Caregiving Relationships and Health

Dementia Clinical Trial

Official title:

Daily Study of Caregiving Relationships and Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04682535
• Other study ID #: HSC20200421H
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2022
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. This is a pilot study wherein the purpose is to test the feasibility and acceptability of study protocols.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 1, 2022
• Est. primary completion date: May 17, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Caregiver Burden
• Caregiver Burnout
• Dementia
• Dementia of Alzheimer Type
• Loneliness
• Relation, Interpersonal
• Relations, Family
• Social Stress

Intervention

Other:
• Social relationships
Exposure to social interactions with spouse, friends, and family. Perceived loneliness, emotional strain, and emotional support.

Locations

Country	Name	City	State
United States	UT Health San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of daily health symptoms	Frequency of adverse health symptoms experienced by participant (e.g., fatigue; 0 to 21)	2 weeks
Primary	Perceived sleep quality	Perceived sleep quality the night prior (1 to 5)	2 weeks
Primary	Physical activity	Participation in at least 30 minutes of moderate to vigorous physical activity (binary)	2 weeks
Primary	Consumption of alcoholic beverages	Consumption of 1 or more alcoholic beverages (binary)	2 weeks
Primary	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	Total salivary cortisol	Area under the curve score to approximate total cortisol output during the day (µg/dL)	2 weeks