Daily Study of Caregiving Relationships and Health

NCT04682535 | Completed

• 1 other identifier: HSC20200421H
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver Burnout; Dementia; Dementia of Alzheimer Type; Relations, Family; Social Stress; Relation, Interpersonal; Loneliness

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Total salivary cortisol

  2 weeks

Study Arms (1)

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

Interventions

Social relationships OTHER

Exposure to social interactions with spouse, friends, and family. Perceived loneliness, emotional strain, and emotional support.

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva samples from a subsample of n=11 caregivers retained, including 4 samples/day for 5 days per caregiver.

MeSH Terms

Conditions

Caregiver Burden; Dementia

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 23, 2020
• Study Start: September 1, 2020
• Primary Completion: May 17, 2021
• Study Completion: September 1, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: IPD available following publication of peer-reviewed manuscripts and made available to peer-reviewers upon request

Locations

US (1)