Partnering Physical and Emotional Fitness: Improving Cardiac Recovery With Training in Emotion Regulation

NCT03303703 | Completed

• 1 other identifier: ANF6098
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Disease; Myocardial Infarction

Keywords

cardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (12)

• 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).

Study Arms (2)

Control

NO INTERVENTION

Usual cardiac rehabilitation and social phone calls for attention control.

Intervention

EXPERIMENTAL

RENEwS intervention is five 60-minute group educational sessions.

Other: RENEwS

Interventions

RENEwS OTHER

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.

Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of CVD
• phase II CR initiated within the past 2 months
• planned 12 weeks of CR
• living independently
• at least 40 years of age

You may not qualify if:

• patients who do not speak English
• have experienced cardiac arrest
• have an implanted pacemaker or defibrillator
• not approved safe for exercise

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• 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.

  PMID: 32205788 DERIVED

MeSH Terms

Conditions

Heart Diseases; Myocardial Infarction

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: October 6, 2017
• Study Start: October 11, 2017
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: March 23, 2020

Record last verified: 2020-03

Locations

US (1)