Clinical trial NCT01764399: Care4U: Self Management Intervention for Older Adult Caregivers
Official title: Care4U: Self Management Intervention for Older Adult Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Keywords: cardiovascular risk factors
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 6
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

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.

Eligibility 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. -

Primary outcomes:
measure: Change in Physical Activity
timeFrame: Baseline, 6 weeks, and 3 months
Secondary outcomes:
measure: Change in healthy diet intake
timeFrame: Baseline, 6 weeks, 3 months
measure: Change in emotional functioning (stress, anxiety, depression)
timeFrame: Baseline, 6 weeks, 3 months
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Bryan Health
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Paula S Schulz, PhD
role: PRINCIPAL_INVESTIGATOR
References: