Care4U: Self Management Intervention for Older Adult Caregivers

Cardiovascular Risk Factor Clinical Trial

Official title:

Care4U: Self Management Intervention for Older Adult Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764399
• Other study ID #: 0552-12-FB
• Status: Completed
• Phase: N/A
• Start date: March 1, 2013
• Est. completion date: December 1, 2013

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 1, 2013
• Est. primary completion date: December 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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. -

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Behavioral:
• Care4U

Locations

Country	Name	City	State
United States	Bryan Health	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Physical Activity	Physical activity will be measured via self-report and with Actigraphy.	Baseline, 6 weeks, and 3 months
Secondary	Change in healthy diet intake	Change in self-reported diet intake	Baseline, 6 weeks, 3 months
Secondary	Change in emotional functioning (stress, anxiety, depression)	Change in self-reported stress, anxiety and depression scores	Baseline, 6 weeks, 3 months