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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Risk Factor
• Intervention / Treatment: Behavioral: Care4U

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Bryan Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical Activity	Physical activity will be measured via self-report and with Actigraphy.	Baseline, 6 weeks, and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in healthy diet intake	Change in self-reported diet intake	Baseline, 6 weeks, 3 months
Change in emotional functioning (stress, anxiety, depression)	Change in self-reported stress, anxiety and depression scores	Baseline, 6 weeks, 3 months

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Paula S Schulz, PhD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 7, 2013
• First Submitted That Met QC Criteria: January 7, 2013
• First Posted (Estimated): January 9, 2013

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: cardiovascular risk factors
• Other Study ID Numbers: 0552-12-FB