Patient-Reported Outcome Measures in Cardiac Rehabilitation: Impact on Health Care

NCT06032013 | Terminated DMC

• 1 other identifier: National School Public Health
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac Rehabilitation (CR) programs are a multidisciplinary process aimed at patient recovery after an acute cardiovascular event or with chronic heart disease, reducing mortality and morbidity, optimising functional capacity and improving quality of life. The aim is to maintain or recover the patient's clinical, physical and psychosocial condition, slowing down or halting the progression of the underlying disease process. It is based on the practice of personalized physical exercise and the adaptation of behaviours towards a healthier lifestyle, ensuring the reduction and control of risk factors. It is considered a cost-effective intervention that is explicitly and formally recommended by the most diverse and important scientific societies. Through the partnership and collaboration between the various health institutions and the academy, the CR program will take place on an outpatient basis, in a supervised manner, starting after risk stratification with a stress test and respective clinical assessment by a cardiologist. The coordinator of the CR program will be a cardiologist, and the entire multidisciplinary team will be responsible for effectiveness and safety, as well as patient assessment and progress.

Conditions

Quality of Life; Cardiac Rehabilitation; Patient-Reported Outcome Measures; Rehabilitation Exercise

Outcome Measures

Primary Outcomes (3)

• EQ5D-5L: Health-related quality of life

  The EQ5D makes it possible to assess quality of life in a given pathology in the general population, presented in different domains. The visual analogue scale of this questionnaire has a score of 0-100. Higher scores mean a better result.

  Before the intervention and up to 8 weeks.

• HADS: Anxiety and depression

  Participants' anxiety and worries are also assessed. Mood disorders, weakness, worry, stress, and depression are common psychological repercussions for patients after a cardiac event, which can trigger hyperventilation reactions. This type of common reaction to emotional extremes such as fear, anxiety, or stress in participants can have a direct impact on involvement in CR programs. This questionnaire is made up of 14 questions. Lower scores mean a better result.

  Before the intervention and up to 8 weeks.

• BREQ-2: Behavioural Regulations in Exercise Questionnaire

  Assessment of the different aspects of motivational regulation for exercise. It is a questionnaire that evaluates and represents the differences in the ways in which people's behaviour can be regulated and how these differences are experienced.

  Before the intervention and up to 8 weeks.

Secondary Outcomes (6)

• Heart rate

  Before, during and up to 8 weeks of the program.

• Blood pressure

  Before, during and up to 8 weeks of the program.

• Peripheral oxygen saturation

  Before, during and up to 8 weeks of the program.

• Exercise Capacity

  During and up to 8 weeks of the program.

• Weight

  Before the intervention and up to 8 weeks.

Study Arms (1)

Cardiac Rehabilitation intervention

EXPERIMENTAL

Outpatient intervention with participants after a cardiac event who fulfil the inclusion criteria.

Other: Cardiac rehabilitation program (PROMs)

Interventions

Cardiac rehabilitation program (PROMs) OTHER

The program is multidisciplinary with the following components: * Medical assessment * Physical training and counselling on physical activity * Identification and control of risk factors * Nutritional assessment and counselling * Psychological assessment and intervention * Education and information

Cardiac Rehabilitation intervention

Eligibility Criteria

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

You may qualify if:

• Adult (\> 18 years);
• Low-moderate risk for physical exercise;
• After a cardiac event;
• Have signed an informed consent form.

You may not qualify if:

• Physical or mental limitation to carry out an exercise programme;
• Uncontrolled arrhythmia;
• Severe chronic obstructive pulmonary disease;
• Uncontrolled hypertension;
• Symptomatic peripheral arterial disease;
• Unstable angina;
• Uncontrolled diabetes;
• Acute pulmonary oedema in the last 12 hours;
• Those who refuse to participate.

Sponsors & Collaborators

• José Manuel Afonso Moreira: lead

Study Sites (1)

National School of Public Health

Lisbon, Portugal

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 11, 2023
• Study Start: May 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)