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临床试验/NCT02276287
NCT02276287已完成不适用

HIV Positive Patient's Cognitive and Emotional Illness Perception: a Possible Tool for Understanding Adherence?

University of Milan0 个研究点目标入组 187 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
187
主要终点
Illness representations

研究概览

简要总结

Background: the study aimed to explore HIV positive patients' perceptions toward illness and treatment, and their associations with demographic and clinical variables, in particular with adherence.

Methods: the study was conducted at the outpatients clinic of Infectious Disease of a University Hospital in the north of Italy. Patients were asked to fill out the Illness Perception Questionnaire-Revised. Patient's adherence was measured by: viral load (HIV-RNA copies/ml) and presence at the check up.

详细描述

Data collection Participants were recruited in the waiting room, before their check up visit or the blood test; a researcher explained them the aim of the study and asked them a written informed consent to participate. The accepting patients were asked to fill out the Illness Perception Questionnaire Revised (IPQ-R). Demographic, clinical and adherence data were also collected.

Measures:

  1. Demographic and clinical data: demographic information included age, gender, marital status, education, employment status, nationality. Clinical information, extracted from participants' medical records, included: years diagnosed with HIV, patient history of antiretroviral therapy (ART), years of therapy, presence of fix dose combination of antiretroviral drugs, current therapeutic regimen's type, total number of pills per day, presence of other drugs' therapies, HIV acquisition risk.
  2. Illness representations: measured with the Italian validate version of the IPQ-R24. The questionnaire is divided in three sections: 1) disease identity; 2) opinions and 3) causes. While items on disease identity have dichotomous responses (yes/no), items regarding opinions and causes are constituted by a 5 points Likert scale (from "1=completely disagree" to "5=completely agree").

Identity section explores patients' beliefs about the disease's nature. Fourteen symptoms are listed and patients have to indicate if they have experienced them since being diagnosed with the disease and, if so, if they believe that their symptoms are linked to the disease or not. Opinions section is composed by 38 items exploring how, at the moment, patients perceive their illness condition. Items are grouped into seven factors: 1) Timeline (perception of chronic vs acute duration); 2) Cyclical symptoms (perception of a cyclic vs stable disease); 3) Consequences (perception that the disease has or not serious physical, psychological and social consequences on patients' life); 4) Personal control (perceptions that actions can or cannot be taken to effectively manage the disease); 5) Treatment control (high or low trust in the treatment and its efficacy); 6) Coherence (high or low understanding of the disease); 7) Emotional responses (prevalence of negative emotions vs positive).

Causes section lists 18 possible illness causes and patients have to rate their level of agreement with each item as a cause of their disease. 3. Adherence indexes : measured by HIV-RNA copies/ml and presence at the check up visits(scheduled every 3 months). Patients were considered "adherent" in case of: undetectable viral load or HIV-RNA <40 copies/ml and regular presence at the check up visits (≤ 3 months). Adherence indexes were collected only for patients under treatment (naïve patients and patients in therapy from <1 month were excluded).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HIV positivity
  • age ≥18 years
  • to be able to understand and provide informed consent
  • to be able to understand a questionnaire in Italian
  • not to be psychiatric patient
  • not to be alcohol and/or drugs' abuser

排除标准

  • not HIV positive patients
  • age <18 years
  • inability to understand and provide informed consent
  • inability to understand a questionnaire in Italian
  • to be psychiatric patient
  • to be alcohol and/or drugs' abuser

结局指标

主要结局

Illness representations

时间窗: participants will be followed for the duration of their hospital access, an expected average of 2 hours

Illness Perception Questionnaire Revised (IPQ-R)

次要结局

  • clinical data(from date of HIV diagnosis until the date of the visit in which patients were recruited for the study , assessed from 1984 to 2014)
  • Adherence(Adherence indexes assessed at the last check up visit (from 2 weeks up to 12 months))
  • demographic data(participants will be followed for the duration of their hospital access, an expected average of 2 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniela Leone

PsyD, MS, research fellow

University of Milan

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