A Psychoeducational Intervention Supporting Patients With a New Diagnosis and/or Genetic Carrier Status for an Inherited Cardiac Condition-a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Engagement of clinical staff with identification of patients
研究概览
简要总结
Inherited heart conditions (IHCs) can cause young sudden deaths due to a genetic trait that leads to a thickened heart muscle or abnormal heart rhythms. Relatives of an affected person have a 50% chance of inheriting IHCs and this is determined either through a blood test (predictive genetic test) and/or physical tests such as a heart tracing (electrocardiogram), scan (echocardiogram) and exercise test. When patients find out they are affected or are carriers for an IHC, they have numerous questions about medical management, prognosis, lifestyle; as well as experiencing stress and anxiety because of the impact on their health and risk to their family. Based on published studies and interviews, a psychoeducational intervention underpinned by Self-determination Theory was developed to support these patients An uncontrolled study to determine the feasibility of the intervention and outcome measures will be undertaken. Patients with a new IHC diagnosis or a carrier result aged 16 years and older will be recruited from outpatient clinics in London and will be receive the intervention consisting of a disease-specific information leaflet, a personalised lifestyle consideration guide and participation in a 1-hour group session facilitated by a cardiac genetic nurse. Outcome measures to look at degree of self-determination, autonomy support and competence; and heart-related anxiety will be collected at baseline and at 3 months post intervention. Clinical and socio-demographic data will be obtained from medical notes. The feasibility and acceptability of the intervention will be measured by assessment of the study procedures such as recruitment, retention and any adverse events. It is expected that there will be up to 4 consecutive group sessions and feedback from each session will be used to co-design and refine the intervention model for a definitive clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are aged 16 and older.
- •Patients who have undergone cardiac screening and/or predictive genetic testing for inherited cardiac conditions and are within 6 months of receiving a new diagnosis of an inherited cardiac condition (ICC) and/or have been found to be carriers of a genetic alteration that can cause an ICC.
排除标准
- •Patients who were initially referred to the clinic for reasons other than cardiac screening and/or predictive genetic testing for ICCs.
- •Patients who have undergone cardiac screening and/or predictive genetic testing for ICCs and more than 6 months have passed since receiving a new diagnosis of an ICC and/or a carrier result for a genetic alteration that can cause an ICC.
- •Patients who have undergone cardiac screening and/or predictive genetic testing for ICCs and have received a negative result.
- •Patients below 16 years of age.
- •Patients with insufficient command of written and spoken English to comprehend study documents and participate in the study procedures and discussion.
- •Patients who are already participating in a study involving a psychoeducational intervention, novel cardiac medication or device.
结局指标
主要结局
Engagement of clinical staff with identification of patients
时间窗: 3 months
Number of participants identified for recruitment
Engagement of participants with recruitment procedures
时间窗: 3 months
Number of participants consented, number of participants declined and withdrawn
Completion of data collection
时间窗: 3 months
Rates of data collection at baseline and follow-up, and reasons for missing data
Engagement with psychoeducational intervention
时间窗: 3 months
Rates of intervention uptake and reasons for dropout
次要结局
- Perceived Competence Scale(Measured at baseline and 3 months post intervention)
- Perceived Choice and Awareness of Self Scale(Measured at baseline and 3 months post intervention)
- Health Care Climate Questionnaire(Measured at baseline and 3 months post intervention)
- Heart-related Anxiety (Questionnaire)(Measured at baseline and 3 months post intervention)