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OpenTrials
Completed

NCT Number: NCT01764399

Care4U: Self Management Intervention for Older Adult Caregivers

Older adults caring for others often neglect their own health. This research is being done to see if helping caregivers focus on their own needs can improve their health and ability to care for others

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Key information

Conditions

Cardiovascular Risk Factor

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bryan Health

Lincoln, Nebraska, 68506, United States

About this study

The specific aims are to evaluate the Care4U intervention in order to refine the intervention for a larger clinical trial, which includes 1) subject acceptability of the intervention, 2) evaluation of intervention delivery, fidelity, and data collection, and 3) evaluation of the components of the intervention (patient activation, knowledge, self-efficacy, and CV self-management strategies).

Recruitment was conducted in 2 acute care hospitals from April 2013 through Dec 2013. Six caregivers were enrolled during this time, with one dropping out after baseline.

The participants completing the study (n=5) provided data related to the aim. Four participants were able to use Adobe Connect via the provided laptops with written instructions and phone coaching. Delivery of the intervention via Adobe connect was enjoyed by the participants, with minimal connectivity problems. Participants were interested in websites and videos related to their health, but did not relate exploring these links on the laptop desktop without suggestion from the PI.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Describes self as an informal Caregiver of patient who has undergone cardiac surgery (revascularization, valve, or combination)and performs ≥1 activity of daily living or instrumental activity of daily living for the patient
  • ≥ 65 years
  • Self-reports ≥1 modifiable cardiovascular risk (hypertension, hyperlipidemia, physical inactivity, obesity)
  • Lives in the same residence with patient
  • Oriented to person, place, and time (asking the subject to state their name, where he/she is (for example what building, town and state) and what time it is (time, day, date)
  • Able to hear, and speak and read English

Exclusion criteria

  • Permanent residence in skilled or assisted care facility
  • Participation in 3 times per week exercise during the past 6 months. -

Treatment and study plan

Care4U

Behavioral

Primary outcomes

  1. Change in Physical Activity

    Time frame: Baseline, 6 weeks, and 3 months

    Physical activity will be measured via self-report and with Actigraphy.

Secondary outcomes

  1. Change in healthy diet intake

    Time frame: Baseline, 6 weeks, 3 months

    Change in self-reported diet intake

  2. Change in emotional functioning (stress, anxiety, depression)

    Time frame: Baseline, 6 weeks, 3 months

    Change in self-reported stress, anxiety and depression scores

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 9, 2013
Registry last updated
Sep 5, 2023

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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