Educational Model for Cardiac Patients
26 marzo 2020 aggiornato da: Natássia Condilo Pitta, University of Sao Paulo
Effect of an Educational Model on Physical Activity in Individuals Undergoing the First Percutaneous Coronary Intervention: Randomized Clinical Trial
The purpose of this study was to compare the effect of an educational model, which included cardiac rehabilitation with emphasis on physical activity and telephone follow up, with the usual management of individuals undergoing to first percutaneous coronary intervention, in relation to physical activity five until seven months after discharge.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Randomized controlled trial (RCT) at a public teaching hospital, which has specialized care for CAD in Ribeirão Preto, state of São Paulo, Brazil. The intervention group received usual care and an educational programme and the control group received only usual care.
A researcher (who didn't had contact with the patients) generated the random allocation in SPSS software, concealing it from the investigators in sequentially numbered, sealed and opaque envelopes.
Another researcher performed the individual interview with each participant (baseline) and aplied the instruments of socialdemographic data, physical activity, ansiety and depression, perceived health status and selfefficacy to practice of physical activity. At the end of the interviewThe same researcher opened the envelope to allocate the participants to either intervention or control group. The participants of intervention group remained with the researcher to receive the intervention.
The educational programme consisted of four booklets entitled 1. Percutaneous Transluminal Coronary Angioplasty, 2. Going home after your coronary angioplasty, 3. How to take care of your heart and your health, and 4. How to practice physical activities. The educational programme included the telephone follow-up that contained three calls to motivate the participants to change their lifestyle and clarify doubts. The contents of the booklets were explained step by step to the participants by the researcher who conducted the interviews.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
127
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
São Paulo
-
Ribeirao Preto, São Paulo, Brasile, 14040-902
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Adult patients (18 years or more) of both genders
- Patients undergoing the first percutaneous coronary intervention
- Patients who had a properly functioning home phone line
Exclusion Criteria:
- No cognitive conditions to participate (assessed by the ability to inform the name, current date, day of the week, place, age and place of birth confirmed by the participant's identification document)
- Who did not have clinical or physical conditions to answer the questionnaires (individuals with dyspnea and / or mental confusion)
- Who reported difficulties to speak on the phone (hearing loss)
- Who had sequelae that could influence activities of daily living (limb amputation or paralysis)
- Who had a contraindication to physical exercise, prescribed by the doctor, and who already participated in a supervised cardiac rehabilitation program
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Usual Care
At discharge, paticipants received guidance from health professionals.
The paticipants had a medical return five to seven months after the percutaneous coronary intervention.
|
Hospital health professionals offered orientation on care after discharge
|
|
Sperimentale: Educational model + follow up
The paticipants received the hospital's instructions at discharge and participated in the educational program (booklets with telephone follow-up).
The paticipants had a medical return five to seven months after discharge
|
Orientation from health professionals at discharge, educational program with explanation of booklets and telephone follow-up (three calls)
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in physical activity level from baseline to five to seven months
Lasso di tempo: baseline and five to seven months
|
The "Baecke Questionnaire of Habitual Physical Activity" was developed by Baecke, Burema and Frijters (1982) and validated for the Brazilian population by Florindo et al. (2004, 2006).
The instrument has three dimensions: occupational physical activity (eight questions), physical activity during leisure time (four questions) and leisure and locomotion activities (four questions), totaling 16 questions.
Higher scores indicate a higher level of physical activity.
This questionnaire was used to collect the data at baseline and five to seven months after hospital discharge.
|
baseline and five to seven months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in symptoms of anxiety and depression from baseline to five to seven months
Lasso di tempo: baseline and five to seven months
|
The questionnaire "Hospital Anxiety and Depression Scale" was developed by Zigmond and Snaith (1983) and validated and adapted to Portuguese by Botega et al. (1995).
The Hospital Anxiety and Depression Scale contains 14 multiple choice questions, divided into two subscales: anxiety and depression (composed of seven items each).
Higher scores indicate more symptoms of anxiety and depression.
This questionnaire was used to collect the data at baseline and five to seven months after hospital discharge.
|
baseline and five to seven months
|
|
Change in perceived health status from baseline to five to seven months
Lasso di tempo: baseline and five to seven months
|
The questionnaire "Medical Outcomes Survey 36 - Item Short-Form" developed by Ware and Sherboune (1992).
The investigators used the version licensed by Quality Metric Incorporated (MARUISH, 2011) for use in surveys in Brazil.
The Medical Outcomes Survey 36 - Item Short-Form is a multidimensional questionnaire composed of 36 items that evaluate eight health concepts: functional capacity, physical aspects, pain, general health, vitality, social aspects, emotional aspects, mental health and a comparative question that evaluate the current health conditions with one year ago.
Higher values indicate better perceived health status.
This questionnaire was used to collect the data at baseline and five to seven months after hospital discharge.
|
baseline and five to seven months
|
|
Change in self-efficacy for physical activity from baseline to five to seven months
Lasso di tempo: baseline and five to seven months
|
The questionnaire "Escala de Autoeficácia Para Prática de Atividade Física" developed by Rech et al. (2011) for Brazilian adults and by Borges et al. (2015) that used in the elderly population.
This questionnaire was elaborated from two specific scales of self-efficacy for the practice of physical exercise, proposed by Sallis et al. (1988) and Bandura (2006).
We used the Brazilian adult version (RECH et al., 2011) which contains two domains with five items each in which the answers are dichotomous ( "no" versus "yes").
Higher scores indicate better self-efficacy for physical activity.
The instrument was used to collect the data at baseline and five to seven months after hospital discharge.
|
baseline and five to seven months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Cattedra di studio: Lidia A Rossi, PhD, University of São Paulo at Ribeirão Preto College of Nursing
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 agosto 2017
Completamento primario (Effettivo)
20 dicembre 2018
Completamento dello studio (Effettivo)
30 gennaio 2020
Date di iscrizione allo studio
Primo inviato
24 novembre 2016
Primo inviato che soddisfa i criteri di controllo qualità
28 novembre 2016
Primo Inserito (Stima)
29 novembre 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
30 marzo 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 marzo 2020
Ultimo verificato
1 marzo 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 51805715.0.0000.5393
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .