The Effectiveness of Multimodal Educational Intervention to Improve Adherence to Treatment Regimens in Older Stroke Patients: A Randomised Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 405
- 试验地点
- 3
- 主要终点
- changes in blood pressure
研究概览
简要总结
Stroke is a major cause of morbidity and mortality, especially in low and middle income countries including Iran. Patients with recent stroke or TIA are at high risk for new vascular events. Several evidence based strategies in secondary prevention of stroke are available but frequently underused. The study is aimed to evaluate an intervention to improve patients with Stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 65 years or older
- •able to give informed consent
排除标准
- •recurrent stroke
- •a diagnosis of subarachnoid haemorrhage
- •significant impairments precluding participation - inability to give informed consent
- •another condition likely to impact their participation in the trial (e.g. life-threatening condition other than cardiovascular disease)
- •expected discharge to hospital/nursing home setting
研究组 & 干预措施
Patients based intervention
A multifaceted intervention program will use to improve adherence and clinical outcomes in Stroke patients. This intervention focus on behavioral treatment in the patients.
干预措施: Patient-based intervention (Behavioral)
Family based intervention
Patients and their families will receive a series of educational/motivational interventions.
干预措施: Family based intervention (Behavioral)
Routine counseling
All participants of the study in both group receive the Standard Care. Usually, patients in clinics receive a one-time session of brief advice to use medications regularly lasting approximately 30 minutes and deliver by nurse or physician. Some issues rise in this short session including coexisting diseases, the history of drug use, current disease and advice about the health risks of irregular medication use.
干预措施: Routine counseling (Other)
结局指标
主要结局
changes in blood pressure
时间窗: changes from baseline, 6 Months, 12 months and 18 months follow-up
changes in low-density lipoprotein (LDL)-cholesterol level
时间窗: changes from baseline, 6 Months, 12 months and 18 months follow-up
changes in Patient-reported Adherence Medication Adherence Rating Scale
时间窗: changes from baseline, 6 Months, 12 months and 18 months follow-up
a self-report measure of adherence (Medication Adherence Report Scale \[MARS-5\]) will be used .
次要结局
- Changes in intention to medication adherence(changes from baseline, 6 Months, 12 months and 18 months follow-up)
- Changes in Action Plan(changes from baseline, 6 Months, 12 months and 18 months follow-up)
- Changes in Coping Plan(changes from baseline, 6 Months, 12 months and 18 months follow-up)
- Changes in quality of life(changes from baseline, 6 Months, 12 months and 18 months follow-up)
- Changes in perceived behavioral control to medication adherence(changes from baseline, 6 Months, 12 months and 18 months follow-up)
- Changes in Self-monitoring to medication adherence(changes from baseline, 6 Months, 12 months and 18 months follow-up)
- Changes in Illness Perceptions(changes from baseline, 6 Months, 12 months and 18 months follow-up)
研究者
Amir H Pakpour
Associate Professor of health psychology
Qazvin University Of Medical Sciences