NCT01764399

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

9 months

First QC Date

January 7, 2013

Last Update Submit

August 30, 2023

Conditions

Cardiovascular Risk Factor

Keywords

cardiovascular risk factors

Outcome Measures

Primary Outcomes (1)

  • Change in Physical Activity

    Physical activity will be measured via self-report and with Actigraphy.

    Baseline, 6 weeks, and 3 months

Secondary Outcomes (2)

  • Change in healthy diet intake

    Baseline, 6 weeks, 3 months

  • Change in emotional functioning (stress, anxiety, depression)

    Baseline, 6 weeks, 3 months

Study Arms (2)

Care4U intervention

EXPERIMENTAL

Care4U intervention with 6 weekly sessions focusing on physical activity, healthy eating, self-management, emotional responses.

Behavioral: Care4U

Information group

NO INTERVENTION

The information group receives 6 weekly socialization sessions.

Interventions

Care4UBEHAVIORAL
Care4U intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Permanent residence in skilled or assisted care facility
  • Participation in 3 times per week exercise during the past 6 months. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bryan Health

Lincoln, Nebraska, 68506, United States

Location

Study Officials

  • Paula S Schulz, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2013

First Posted

January 9, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

September 5, 2023

Record last verified: 2023-08

Locations

US(1)