Care4U: Self Management Intervention for Older Adult Caregivers
|ClinicalTrials.gov Identifier: NCT01764399|
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : December 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Risk Factor||Behavioral: Care4U||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Experimental: Care4U intervention
Care4U intervention with 6 weekly sessions focusing on physical activity, healthy eating, self-management, emotional responses.
No Intervention: Information group
The information group receives 6 weekly socialization sessions.
- Change in Physical Activity [ Time Frame: Baseline, 6 weeks, and 3 months ]Physical activity will be measured via self-report and with Actigraphy.
- Change in healthy diet intake [ Time Frame: Baseline, 6 weeks, 3 months ]Change in self-reported diet intake
- Change in emotional functioning (stress, anxiety, depression) [ Time Frame: Baseline, 6 weeks, 3 months ]Change in self-reported stress, anxiety and depression scores
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764399
|United States, Nebraska|
|Lincoln, Nebraska, United States, 68506|