The effect of reinforcing an educational programme using telephone follow-up on health-related quality of life of individuals using warfarin: A randomised controlled trial.

OBJECTIVES: To evaluate the effect of reinforcing an educational programme through telephone follow-up on health-related quality of life and anxiety and depression symptoms in individuals starting warfarin therapy. BACKGROUND: Educational interventions have improved quality of life in individuals using warfarin. Few studies have examined the addition of telephone follow-up to enhance educational interventions. DESIGN: Randomised controlled trial in outpatient setting. METHODS: Hospitalised adults starting warfarin therapy who agreed to participate received an educational programme about the warfarin treatment. At discharge, they were randomised to receive either five telephone follow-up calls (intervention) or no telephone calls (controls). Both groups were evaluated for health-related quality of life (using Duke Anticoagulation Satisfaction Scale) and symptoms of anxiety and depression (using Hospital Anxiety and Depression Scale) at three and six months post-discharge. Groups were compared at each time by independent-samples t test, and over time by repeated-measures analysis of variance, with time (three and six months), groups (intervention and control) and an interaction between time and group as factors. Level of significance was set at 0.05. The Consolidated Standards of Reporting Trials was used for reporting. RESULTS: Fifty-two individuals (26 per group) completed the study. There were no statistical differences between groups in health-related quality of life, anxiety and depression symptoms, at both times post-discharge. Participants who received follow-up telephone calls reported better positive psychological impact (a subscale of quality of life) than controls. CONCLUSIONS: Reinforcing an educational programme with telephone follow-ups did not have an overall effect on health-related quality of life of individuals using warfarin but promoted positive psychological impact. RELEVANCE TO CLINICAL PRACTICE: The low cost of reinforcing educational programmes with telephone calls and the improvement in positive psychological aspects indicate that this type of intervention is still a promising intervention that could be further investigated and improved.

Validation of the Brazilian Version of the Patient Activation Measure 13.

BACKGROUND AND PURPOSE: To assess the psychometric properties of the PAM13 Brazilian-Portuguese (PAM13-B) among outpatients with chronic diseases. METHODS: 513 adults participated, diagnosed with a chronic disease for more than 6 months, under outpatient monitoring. Reliability was tested using internal consistency and test-retest reliability. Construct validity was verified through different techniques (correlation between activation and self-esteem measures, anxiety, depression and health status), known-groups validity and dimensionality by means of confirmatory factor analysis. Significance was set at 0.05. RESULTS: The PAM13-B presented appropriate results for internal consistency (α = 0.83) and test-retest reliability (intraclass correlation coefficient [ICC] = 0.81). A moderate correlation was found between activation and self-esteem only (r = 0.43, p < 0.001). The one-dimensional structure was not confirmed in the sample analyzed. CONCLUSIONS: In the study sample, the version PAM13-B demonstrated its reliability and validity, but with a two-factor structure.

Cultural adaptation and validation of the Brazilian Version of the Patient Activation Measure-22 items.

OBJECTIVE: To adapt and validate the Patient Activation Measure (PAM22) in a sample of Brazilians with chronic diseases under outpatient monitoring. METHOD: Adaptation process comprises translation, back translation, analysis by a committee of judges, semantic analysis, and pre-test. Psychometric validation was performed with 513 individuals. Construct validity was analyzed through Pearson's correlation, Student's t-test and Structural Equation Modeling; reliability was assessed by the intraclass correlation coefficient and Cronbach's Alpha. RESULTS: The internal consistency was adequate and test-retest reliability was low to moderate (p < 0.05). Validity evidence was found on the convergent construct, with statistically significant correlations between measures of activation, self-esteem, anxiety, depression, and health status. The one-dimensionality of the theoretical model was not confirmed in the adapted version. CONCLUSION: Results have shown that the adapted version is reliable and valid, although the theoretical model cannot be explained in a single dimension.

Cultural adaptation and validation of the Brazilian Version of the Patient Activation Measure-22 items / Adaptación cultural y validación de la versión brasileña de Patient Activation Measure22 ítems / Adaptação cultural e validação da versão brasileira do Patient Activation Measure-22 itens

ABSTRACT Objective: To adapt and validate the Patient Activation Measure (PAM22) in a sample of Brazilians with chronic diseases under outpatient monitoring. Method: Adaptation process comprises translation, back translation, analysis by a committee of judges, semantic analysis, and pre-test. Psychometric validation was performed with 513 individuals. Construct validity was analyzed through Pearson's correlation, Student's t-test and Structural Equation Modeling; reliability was assessed by the intraclass correlation coefficient and Cronbach's Alpha. Results: The internal consistency was adequate and test-retest reliability was low to moderate (p < 0.05). Validity evidence was found on the convergent construct, with statistically significant correlations between measures of activation, self-esteem, anxiety, depression, and health status. The one-dimensionality of the theoretical model was not confirmed in the adapted version. Conclusion: Results have shown that the adapted version is reliable and valid, although the theoretical model cannot be explained in a single dimension.

RESUMEN Objetivo: Adaptar y validar el Patient Activation Measure (PAM22) en una muestra de brasileños con enfermedades crónicas y en seguimiento ambulatorio. Método: El proceso de adaptación consistió en traducción, retrotraducción, análisis por comité de jueces, análisis semántico y pre-test. Se realizó la validación psicométrica con 513 personas. La validez de constructo fue analizada por la correlación de Pearson, prueba t de Student y modelado de ecuaciones estructurales y confiabilidad por el coeficiente de correlación intraclase y alfa de Cronbach. Resultados: la consistencia interna fue adecuada y la confiabilidad test-retest fue de débil a moderada (p < 0,05). Se encontró evidencias de la validez de constructo convergente, con correlaciones estadísticamente significativas entre las medidas de activación, autoestima, ansiedad, depresión y estado de salud. La unidimensionalidad del modelo teórico no fue confirmada en la versión adaptada. Conclusión: Los resultados mostraron que la versión adaptada es confiable y válida, aunque no se explica el modelo teórico en una sola dimensión.

RESUMO Objetivo: Adaptar e validar o Patient Activation Measure (PAM22) em uma amostra de brasileiros com doenças crônicas, em acompanhamento ambulatorial. Método: A adaptação consistiu em tradução, retrotradução, análise por comitê de juízes, análise semântica e pré-teste. A validação psicométrica foi realizada com 513 indivíduos. A validade de constructo foi analisada pela correlação de Pearson, teste t de Student e modelagem de equações estruturais e confiabilidade pelo coeficiente de correlação intraclasse alfa de Cronbach. Resultados: A consistência interna foi adequada e a confiabilidade teste-reteste foi de fraca a moderada (p < 0,05). Encontrou-se evidências da validade de constructo convergente, com correlações estatisticamente significantes entre as medidas de ativação, autoestima, ansiedade, depressão e estado de saúde. A unidimensionalidade do modelo teórico não foi confirmada na versão adaptada. Conclusão: Os resultados evidenciaram que a versão adaptada é confiável e válida, embora o modelo teórico não seja explicado em uma única dimensão.

Instrument for Assessing Knowledge of Oral Anticoagulant Therapy: Construction and Validation.

BACKGROUND AND PURPOSE: A valid and reliable assessment tool is fundamental for evaluating the knowledge of individuals about using oral anticoagulant therapy (OAT). The purpose of this study was to develop a tool to assess knowledge about OAT and provide evidence to support its use in people living in developing countries. METHODS: Construction and validation: development of items; assessment of face and content validity; pilot study; application of the instrument to a sample of 500 users of OAT to analyze dimensionality, convergent validation, and reliability. RESULTS: Analysis of dimensionality suggested a unidimensional instrument. Direct correlation between knowledge of OAT and educational level was confirmed (r = .61, p < .001) (validity of construct). Reliability measured by KR-20 was 0.86. CONCLUSIONS: The new instrument was shown to be valid and reliable for assessing knowledge of OAT in the population studied.

Efeito do acompanhamento telefônico na qualidade de vida relacionada à saúde de pacientes nos primeiros seis meses de uso da varfarina: ensaio clínico aleatorizado / Impact of telephone follow-up in patient's health-related quality of life during the first six months of warfarin use: randomized clinical trial

A varfarina é um anticoagulante oral, antivitamina K, amplamente utilizado na prevenção de trombos intravasculares de diferentes etiologias. Exige um controle rigoroso e complexo em decorrência da sua interação com outros fármacos e alimentos, o que pode interferir na Qualidade de Vida Relacionada à Saúde (QVRS) dos usuários. Intervenções educativas têm sido utilizadas para diminuir o impacto dessa terapia na QVRS. O objetivo principal deste estudo foi comparar o efeito na QVRS de duas intervenções educativas em pacientes que iniciaram o uso de varfarina pela primeira vez durante a internação, aos três e seis meses após a alta. Como objetivos secundários, comparamos a presença de sintomas de ansiedade e depressão e a adequação do valor do International Normalized Ratio (INR) na faixa terapêutica indicada, entre os grupos. Este foi um estudo experimental com designação aleatória nos dois grupos. Os pacientes do grupo intervenção (GI) receberam o programa educativo com seguimento por telefone após a alta e os do grupo controle (GC) receberam o programa educativo sem o acompanhamento telefônico. O estudo foi aprovado por Comitê de Ética em Pesquisa e foi registrado na base ClinicalTrials.gov. A pesquisa foi conduzida no Hospital Estadual de Ribeirão Preto e no Hospital Estadual de Américo Brasiliense. Foram incluídos pacientes que iniciaram o uso da varfarina, pela primeira vez, maiores de 18 anos e com telefone para contato. O programa educativo foi norteado pela teoria de Bandura e composto por informações verbais e escritas sobre o tratamento, as quais foram apresentadas durante a internação. Os participantes do GI receberam cinco contatos telefônicos para o reforço dessas informações, após a alta hospitalar. Ambos os grupos tiveram dois encontros presenciais, aos três e aos seis meses, para avaliação das variáveis desfechos: QVRS (avaliada pela versão brasileira da Duke Anticoagulation Satisfaction Scale - DASS) e sintomas de ansiedade e de depressão (avaliados pelas subescalas da Hospital Anxiety and Depression Scale - HADS). Para comparar o DASS e as escalas do HADS, realizamos teste t de Student para amostras independentes. Para compararmos os grupos ao longo do tempo, em relação à QVRS, foi realizada Análise da Variância (ANOVA) para medidas repetidas, tendo como fatores o tempo (três e seis meses), o grupo (intervenção ou controle) e uma interação de tempo por grupo. O nível de significância adotado foi de 0,05. Os grupos eram similares quanto às caracterizações sociodemográfica e clínica. A maioria dos participantes eram casados, do sexo feminino e com média de idade de 55 anos (D.P=15). As indicações mais frequentes para o início da varfarina foram trombose venosa profunda e tromboembolismo pulmonar. Não encontramos diferenças estatisticamente significantes entre as médias de QVRS, ansiedade e depressão dos dois grupos, aos três e aos seis meses após a alta

Warfarin is an oral anticoagulant, antivitamin K, widely used in the prevention of intravascular thrombi of different etiologies. It requires rigorous and complex control as a result of its interaction with other drugs and foods, which may interfere with users' Quality of Life Related to Health (HRQoL). Educational interventions have been used to lessen the impact of this therapy. The main objective was to compare the HRQoL, at three and six months after discharge, of two groups of patients who started using warfarin for the first time during hospitalization. Secondary objectives, were to compare the presence of anxiety and depression symptoms and the adequacy of the International Normalized Ratio (INR) value in the indicated therapeutic range, between the groups. It is an experimental study with random designation in two groups. The patients in the intervention group (IG) received the educational program with telephone follow-up after discharge and those in the control group (CG) received the educational program without telephone follow-up. The study was approved by the Research Ethics Committee and was enrolled in the ClinicalTrials.gov database. The research was conducted at the State Hospital of Ribeirão Preto and the Hospital Estadual de Américo Brasiliense and included patients who started using warfarin for the first time, over 18 years and with a telephone to contact. The educational program was guided by the Bandura Theory and was composed of verbal and written information about the treatment and approached during hospitalization. GI participants received five telephone contacts to reinforce this information after discharge. Both groups had two face-to-face meetings at three and six months for the evaluation of the outcome variables: HRQOL (assessed by the Brazilian version of the Duke Anticoagulation Satisfaction Scale - DASS) and symptoms of anxiety and depression (assessed by the subscales of Hospital Anxiety and Depression Scale - HADS). To compare the DASS and the HADS scales, we performed Student's t-test for independent samples. In order to compare the groups over time, in relation to HRQoL, we performed Variance Analysis (ANOVA) for repeated measures, taking as factors the time (three and six months), the group (intervention or control) and a time interaction per group. The level of significance was set at 0.05. The groups were similar in sociodemographic and clinical characterization. The majority of the participants were married, female and with an average age of 55 years (D.P = 15). The most frequent indications for the initiation of warfarin were deep venous thrombosis and pulmonary thromboembolism. We did not find statistically significant differences between the means of HRQoL, anxiety and depression of the two groups at three and six months after discharge