Care4U: Self Management Intervention for Older Adult Caregivers
This study is not yet open for participant recruitment.
Verified January 2013 by University of Nebraska
Sponsor:
University of Nebraska
Information provided by (Responsible Party):
Paula S. Schulz, PhD, RN, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01764399
First received: January 7, 2013
Last updated: January 8, 2013
Last verified: January 2013
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Purpose
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.
|
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764399
Contacts
| Contact: Paula S Schulz, PhD | 402.472.7336 | pschulz@unmc.edu |
Locations
| 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 |
| ClinicalTrials.gov 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 |
ClinicalTrials.gov processed this record on May 23, 2013