Daily Study of Caregiving Relationships and Health

• Sponsor: The University of Texas Health Science Center at San Antonio (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04682535
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 23
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Caregiver Burnout; Dementia; Dementia of Alzheimer Type; Relations, Family; Social Stress; Relation, Interpersonal; Loneliness	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 Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Daily Study of Caregiving Relationships and Health
• Actual Study Start Date: Sep 1, 2020
• Actual Primary Completion Date: May 17, 2021
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Frequency of daily health symptoms [2 weeks]

   Frequency of adverse health symptoms experienced by participant (e.g., fatigue; 0 to 21)

2. Perceived sleep quality [2 weeks]

   Perceived sleep quality the night prior (1 to 5)

3. Physical activity [2 weeks]

   Participation in at least 30 minutes of moderate to vigorous physical activity (binary)

4. Consumption of alcoholic beverages [2 weeks]

   Consumption of 1 or more alcoholic beverages (binary)

5. 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)

Secondary Outcome Measures

1. Total salivary cortisol [2 weeks]

   Area under the curve score to approximate total cortisol output during the day (μg/dL)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT Health San Antonio	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• The University of Texas Health Science Center at San Antonio

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT04682535
• Other Study ID Numbers: HSC20200421H
• First Posted: Dec 23, 2020
• Last Update Posted: Jun 22, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dementia; Alzheimer Disease; Caregiver Burden

Study Results

No Results Posted as of Jun 22, 2022