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Care4U: Self Management Intervention for Older Adult Caregivers

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 9, 2013
Last Update Posted: December 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Paula S. Schulz, PhD, RN, University of Nebraska
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

Condition Intervention
Cardiovascular Risk Factor Behavioral: Care4U

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Further study details as provided by Paula S. Schulz, PhD, RN, University of Nebraska:

Primary Outcome Measures:
  • Change in Physical Activity [ Time Frame: Baseline, 6 weeks, and 3 months ]
    Physical activity will be measured via self-report and with Actigraphy.

Secondary Outcome Measures:
  • Change in healthy diet intake [ Time Frame: Baseline, 6 weeks, 3 months ]
    Change in self-reported diet intake

  • Change in emotional functioning (stress, anxiety, depression) [ Time Frame: Baseline, 6 weeks, 3 months ]
    Change in self-reported stress, anxiety and depression scores

Enrollment: 6
Study Start Date: March 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Care4U intervention
Care4U intervention with 6 weekly sessions focusing on physical activity, healthy eating, self-management, emotional responses.
Behavioral: Care4U
No Intervention: Information group
The information group receives 6 weekly socialization sessions.

Detailed Description:

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.


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. -
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764399

United States, Nebraska
Bryan Health
Lincoln, Nebraska, United States, 68506
Sponsors and Collaborators
University of Nebraska
  More Information

Responsible Party: Paula S. Schulz, PhD, RN, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT01764399     History of Changes
Other Study ID Numbers: 522-12-FB
First Submitted: January 7, 2013
First Posted: January 9, 2013
Last Update Posted: December 15, 2014
Last Verified: December 2014

Keywords provided by Paula S. Schulz, PhD, RN, University of Nebraska:
cardiovascular risk factors