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Effect of Education in Rheumatoid Arthritis

18 avril 2021 mis à jour par: Irem Yildiz Cilengiroglu, Trakya University

Effect of Education on Disease Management to Women With Rheumatoid Arthritis on the Quality of Life and Levels of Anxiety and Depression

This randomized controlled study aimed to determine the effect of education on disease management on the quality of life, and anxiety and depression levels of women with Rheumatoid Arthritis.

The hypotheses of the current study are as below:

H0: Education on disease management in women with Rheumatoid Arthritis does not affect the quality of life and anxiety and depression levels.

H1: Education on disease management in women with Rheumatoid Arthritis affects the quality of life and anxiety and depression levels.

Patients and Methods: The study was conducted with 66 women with Rheumatoid Arthritis (32 intervention, 34 control groups) at the rheumatology clinic and polyclinic of a university hospital between February and October 2019, in the city of Edirne, Turkey. Data were collected with "Patient Information Form", "Rheumatoid Arthritis Quality of Life Scale", "Health Assessment Questionnaire" and "Hospital Anxiety Depression Scale".

Aperçu de l'étude

Description détaillée

Study design and participants This pretest and posttest prospective study was conducted as randomized controlled between February 2019 and October 2019 in the outpatient and inpatient clinics of the Department of Rheumatology of a university hospital in Edirne, Turkey.

Two study groups, control (n = 40) and intervention (n = 40) were randomized controlled groups with 80% power analysis and 95% confidence interval. A single-blind technique was used to eliminate any bias. The patients were not informed of the group to which they belonged. The patients were selected using a simple random sampling method and divided into intervention and control groups using the Research Randomizer program. In the intervention group, 40 women with RA were interviewed at baseline (first interview). In the 3rd month (last interview), eight patients were excluded for the following reasons: four did not wish to continue the study, three could not be reached, and one patient did not complete the forms. Therefore, 32 women with RA were finally included in the intervention group. In the control group, 40 patients were interviewed at baseline. In the 3rd month (last interview), seven patients were excluded for the following reasons: four patients did not wish to continue the study and three patients could not be reached. Therefore, 34 women with RA were finally included in the control group. The study included a total of 66 women with RA, including intervention (n= 32) and control (n= 34) groups. Flow chart of data collection for women with RA is presented Figure 1.

Data collection tools Data were collected by The Patient Information Form, Rheumatoid Arthritis Quality of Life Scale, the Health Assessment Questionnaire, and the Hospital Anxiety Depression Scale.

Patient Information Form: Our study was developed by researchers in line with a literature review on the subject. (Bozbas & Gurer, 2018; Fall et al., 2013; Moghadam et al., 2018; Neto et al., 2009). The form consisted of eight questions about sociodemographic characteristics (age, marital status, education, etc.), clinical diagnosis, treatment of RA, concomitant chronic disease, and deformity affected by arthritis.

Rheumatoid Arthritis Patient Education Booklet: The content of the booklet was prepared by researchers in line with the literature. (arthritis.org; Moghadam et al., 2018; nras.org.uk; Rahim & Cheng, 2018). The education topics included description, symptoms, and signs of RA, diagnostic methods, treatment choices, information on medications, RA in pregnancy, disease management information, nutritional recommendations, emotional health, and support in daily living.

Data collection Patients were interviewed twice, at baseline and at the 3rd month. All forms were applied to the patients in the intervention and control groups at baseline. The patients were assigned to the intervention group at random and participated in a one-to-one training program consisting of a 30-min onset session. The Rheumatoid Arthritis Patient Education Booklet prepared by the researchers was administered to patients in the intervention group during education. The inpatients were given one-to-one training in the patient's room during quiet periods. The outpatients were trained in the outpatient clinic, as tis was considered a suitable venue. In the 3rd month, all forms were applied again to the patients in the intervention group, and the same forms were applied to the untrained patients in the control group. The application of the forms took approximately 15 min, and the interviews were conducted face-to-face with the patients.

Data analysis Data were analyzed using IBM SPSS 20.0 program. Socio-demographic data were analyzed using the mean, standard deviation, and frequency. The Mann-Whitney U paired-group test was used to compare results that did not show a normal distribution. The Fisher's exact test, Pearson chi-square test, and continuity correction test were used. The Wilcoxon signed-rank test was used for the paired comparisons in the comparison of qualitative data. The significance level was set at p < 0.05.

Ethical considerations A University Research Ethics Committee was confirmed the study protocol, which adhered to the Helsinki Declaration (Approval number: 2018/344). Before taking part in the study, all of the patients signed consent forms. Participants were informed that their personal information and privacy would be protected. Patients who did not want to continue to participate in the study were free to leave the study at any stage.

Type d'étude

Interventionnel

Inscription (Réel)

66

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Edirne, Turquie, 22030
        • Trakya University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • To be female
  • 18 years of age and older
  • Diagnosed with Rheumatoid Arthritis who reached the 2010 American College of Rheumatology (ACR) criterion
  • Had a disease period of at least 6 months

Exclusion Criteria:

  • Other serious and chronic mental disorders
  • Communication difficulties
  • Illiteracy

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation factorielle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Intervention group
Patients were interviewed twice, at baseline and at the 3rd month. All forms were applied to the patients in the intervention group at baseline. The patients were assigned to the intervention group at random and participated in a one-to-one training program consisting of a 30-min onset session. The Rheumatoid Arthritis Patient Education Booklet prepared by the researchers was administered to patients in the intervention group during education. In the 3rd month, all forms were applied again to the patients in the intervention group.
The patients in the intervention group participated in a one-to-one training program consisting of a 30-min onset session.
Aucune intervention: Control group
Patients were interviewed twice, at baseline and at the 3rd month. All forms were applied to the patients in the control group at baseline. In the 3rd month, the same forms were applied to the untrained patients in the control group.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from baseline Rheumatoid Arthritis Quality of Life Questionnaire in the third month
Délai: Patients' quality of life assess at baseline and in the third month.
The questionnaire consists of 30 questions, each with a score of "yes" = 1 or "no" = 0. The scores ranged from 0 to 30, with high scores showing poor quality of life.
Patients' quality of life assess at baseline and in the third month.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change from baseline Hospital Anxiety and Depression Scale (HADS) in the third month
Délai: Patients' HADS scores assess at baseline and in the third month.
The HADS includes both anxiety and depression subscales, and consists of 14 items, 7 of which examine depression and 7 of which examine anxiety. Answers are assessed on a four-point likert scale and graded between 0 and 3. The purpose of the scale is not to diagnose but to assess the risk group by checking for anxiety and depression over a short period
Patients' HADS scores assess at baseline and in the third month.
Change from baseline Stanford Health Assessment Questionnaire (HAQ) in the third month
Délai: Patients' HAQ score assess at baseline and the third month.
The HAQ is composed of 20 questions that are divided into eight categories: waking up, moving, feeding, dressing and grooming, hygiene, grip, reach, and tasks. Every question has four possible answers: no challenge (0), some difficulty (1), a lot of difficulty (2), and unable to do (3). the score is computed as an average of eight domains with scores varying from 0 to 3, with a higher score displayed significant impairment.
Patients' HAQ score assess at baseline and the third month.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chercheur principal: Irem Yildiz Cilengiroglu, Trakya University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

4 mars 2019

Achèvement primaire (Réel)

6 mars 2020

Achèvement de l'étude (Réel)

26 juin 2020

Dates d'inscription aux études

Première soumission

14 avril 2021

Première soumission répondant aux critères de contrôle qualité

18 avril 2021

Première publication (Réel)

20 avril 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 avril 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 avril 2021

Dernière vérification

1 avril 2021

Plus d'information

Termes liés à cette étude

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