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OpenTrials
Completed

NCT Number: NCT04682535

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Social relationships

Other

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

Primary outcomes

  1. Frequency of daily health symptoms

    Time frame: 2 weeks

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

  2. Perceived sleep quality

    Time frame: 2 weeks

    Perceived sleep quality the night prior (1 to 5)

  3. Physical activity

    Time frame: 2 weeks

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

  4. Consumption of alcoholic beverages

    Time frame: 2 weeks

    Consumption of 1 or more alcoholic beverages (binary)

  5. Potential binge eating behaviors

    Time frame: 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 outcomes

  1. Total salivary cortisol

    Time frame: 2 weeks

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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 23, 2020
Registry last updated
Sep 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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