NCT03303703|Completed
Loading search results
Sponsor study identifier
interventional
34
1 country
1
Study Start
October 11, 2017
Actual (reported)Primary Completion
October 31, 2018
Actual (reported)Study Completion
October 31, 2018
Actual (reported)Patients who have just experienced a first major cardiac event are at risk of experiencing heightened negative emotions, which further negatively impact self-management of health behaviors. For those patients in phase II cardiac rehabilitation, there is an opportunity to address physical and emotional wellbeing to optimize self-management of diet and exercise. This study will pilot test an intervention aimed at improving these patients' abilities to regulate their emotions as a mechanism to minimize psychological distress and improve self-management of diet and exercise, as well as improve quality of life. This innovative pilot will generate knowledge about the impact of emotion regulation in first event cardiac rehabilitation patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 20, 2017
Actual (reported)October 6, 2017
Actual (reported)October 11, 2017
Actual (reported)October 31, 2018
Actual (reported)October 31, 2018
Actual (reported)Change in Quality of life
Quality of life will be assessed with the 29-item Perceived Health Status (PROMIS-29). This measure examines quality of life across chronic illness populations. Total score of the PROMIS-29 will be used in the analysis of quality of life.
baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).
Change in Psychological symptoms- Depression
baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).
Change in Psychological symptoms- Anxiety
baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).
Change in Psychological symptoms- Rumination
baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).
Change in Self-management behaviors- Diet
baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).
Change in Self-management behaviors- Exercise
baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).
Usual cardiac rehabilitation and social phone calls for attention control.
RENEwS intervention is five 60-minute group educational sessions.
The intervention participants will meet with a trained interventionist for five 60-minute sessions as a group (two groups of five participants each). In the sessions time will be divided between didactic presentation of material, active practicing of techniques, group work focused on case studies, and worksheets for further practice at home. Topics covered within the intervention include emotional awareness, balancing emotional and physical wellbeing, selecting and implementing emotion regulation strategies (such as situation selections, mindfulness, engagement/avoidance, reappraisal, and emotional sharing), and emotional monitoring.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Moore SM, Musil CM, Alder ML, Pignatiello G, Higgins P, Webel A, Wright KD. Building a Research Data Repository for Chronic Condition Self-Management Using Harmonized Data. Nurs Res. 2020 Jul/Aug;69(4):254-263. doi: 10.1097/NNR.0000000000000435.
34 participants (actual enrollment reported by the registry).
First Submitted
September 20, 2017
First Posted
October 6, 2017
Study Start
October 11, 2017
Actual (reported)Study of Access Site for Enhancing PCI in STEMI for Seniors (SAFE STEMI for Seniors)
Contact the study team to confirm eligibility.
Primary Completion
October 31, 2018
Actual (reported)Study Completion
October 31, 2018
Actual (reported)Last Updated
March 23, 2020
Record last verified: 2020-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: