Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Care4U: Self Management Intervention for Older Adult Caregivers

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by University of Nebraska
Information provided by (Responsible Party):
Paula S. Schulz, PhD, RN, University of Nebraska Identifier:
First received: January 7, 2013
Last updated: January 8, 2013
Last verified: January 2013

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Change in Physical Activity [ Time Frame: Baseline, 6 weeks, and 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in self-reported diet intake

  • Change in emotional functioning (stress, anxiety, depression) [ Time Frame: Baseline, 6 weeks, 3 months ] [ Designated as safety issue: No ]
    Change in self-reported stress, anxiety and depression scores

Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 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.


Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01764399

Contact: Paula S Schulz, PhD 402.472.7336

United States, Nebraska
Bryan Health Not yet recruiting
Lincoln, Nebraska, United States, 68506
Sponsors and Collaborators
University of Nebraska
  More Information

No publications provided

Responsible Party: Paula S. Schulz, PhD, RN, Assistant Professor, University of Nebraska Identifier: NCT01764399     History of Changes
Other Study ID Numbers: 522-12-FB
Study First Received: January 7, 2013
Last Updated: January 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
cardiovascular risk factors processed this record on November 20, 2014