Study on the Efficacy of HE and Therapeutic Group Factors on CR and QoL

NCT ID: NCT06127537

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2024-06-16

Brief Summary

This randomised study evaluates the efficacy of health education and therapeutic group factors on cardiac rehabilitation and quality of life in coronary patients attending cardiac rehabilitation programmes in Extremadura.

Detailed Description

Cardiac rehabilitation has been shown to be effective in improving the quality of life of patients who have suffered a cardiovascular event, as well as in preventing future cardiovascular events, demonstrating an increase in survival of between 20% and 30%, with a Class IA recommendation. Due to the prevalence of cardiovascular disease, both nationally and globally, it is important to study the benefits of these cardiac rehabilitation programmes in order to encourage their use. However, several studies have shown that for the programme to be effective, 5% to 10% weight loss must be achieved in patients, adequate nutritional education must be implemented, and behavioural and psychological intervention programmes must be incorporated in order to have an impact on adherence, psychological well-being, and coping with exercise intolerance. This project aims to study the effectiveness of health education and therapeutic group factors in cardiac rehabilitation and on quality of life in coronary patients in Cardiac Rehabilitation Units in Extremadura, including in the analysis anthropometric and body composition, nutritional, cognitive, emotional and lifestyle factors, which could act as mediators of cardiac function, reactivity to neuro-cardiovascular stress, anxiety, depression, anger-hostility, rehospitalisation, adherence, and adherence to treatment.

Conditions

Cardiac Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control Group

Health Education Programme in cardiac rehabilitation without a Therapeutic Intervention Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental Group

Health Education Programme in cardiac rehabilitation with a Therapeutic Intervention Group

Group Type: EXPERIMENTAL

Therapeutic Intervention Group

Intervention Type: BEHAVIORAL

The therapeutic group factors that are worked on in the group session with a psychologist are:

• Altruism.
• Cohesion: feeling of belonging and acceptance in a group.
• Universality: identification with the feelings, ideas or problems of the other group members.
• Interpersonal-internalisation learning: the patient understands himself/herself by sharing his/her experience with the group.
• Interpersonal-externalisation learning: the group offers the patient the possibility to express his own experience and to change his attitudes towards others.
• Counselling.
• Identification: assumption of behavioural patterns of other members as one's own.
• Reactualisation of the family experience.
• Understanding of one's own internal motivations.
• Reciprocal stimulation: the improvement of other members encourages them to solve or approach their problems in a more favourable way.
• Existential factors: empowerment of the individual.

Interventions

Therapeutic Intervention Group

The therapeutic group factors that are worked on in the group session with a psychologist are:

• Altruism.
• Cohesion: feeling of belonging and acceptance in a group.
• Universality: identification with the feelings, ideas or problems of the other group members.
• Interpersonal-internalisation learning: the patient understands himself/herself by sharing his/her experience with the group.
• Interpersonal-externalisation learning: the group offers the patient the possibility to express his own experience and to change his attitudes towards others.
• Counselling.
• Identification: assumption of behavioural patterns of other members as one's own.
• Reactualisation of the family experience.
• Understanding of one's own internal motivations.
• Reciprocal stimulation: the improvement of other members encourages them to solve or approach their problems in a more favourable way.
• Existential factors: empowerment of the individual.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of coronary heart disease, referred to the "Cardiac Prevention and Rehabilitation Unit".

Exclusion Criteria

• Patients with disabling psychiatric disorders.
• Existence of pacemaker or automatic defibrillator.
• Presence of pregnancy or breastfeeding.
• Presence of medical conditions related to oncological conditions requiring chronic treatment with drugs or other substances.
• Any condition that, in the opinion of the investigators, would disqualify the subject from participation in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Regional Development Fund

OTHER

Sponsor Role: collaborator

Universidad de Extremadura

OTHER

Sponsor Role: lead

Responsible Party

Francisco Jose Rodriguez Velasco

Professor PhD, University of Extremadura

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francisco J Rodríguez Velasco, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Extremadura

Locations

Servicio Extremeño de Salud

Badajoz, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Francisco J Rodríguez Velasco, PhD

Role: CONTACT

fcorodriguezv@unex.es

+34 924289839 ext. 89839

Guadalupe Gil Fernández, PhD

Role: CONTACT

ggilfer@unex.es

+34 924489674 ext. 86674

Facility Contacts

Francisco J Rodríguez Velasco, PhD

Role: primary

fcorodriguezv@unex.es

+34 924289839 ext. 89839

María Yuste Domínguez, MD

Role: backup

maria.yusted@salud-juntaex.es

+34 924218100 ext. 49514

Other Identifiers

IB20186

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

134/2020

Identifier Type: OTHER

Identifier Source: secondary_id

19/10/2020

Identifier Type: OTHER

Identifier Source: secondary_id

134/2020

Identifier Type: -

Identifier Source: org_study_id