Effectiveness of Cue-based Intervention in Improving Prospective Memory by Enhancing Medication Adherence in Patients With Schizophrenia and Schizoaffective Disorder: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Medication adherence
研究概览
简要总结
Medication adherence is a major challenge while treating patients with major mental illnesses like schizophrenia and schizoaffective disorder. This interventional study aims to assess the improvement in prospective memory and thus medication adherence by giving time and event-based cues to the participants.
详细描述
According to available evidence, prospective memory (PM) is important in daily functioning but is impaired in schizophrenia. However, there were hardly any Indian studies on this topic. Medication adherence is one of the challenges which clinicians often face during treatment. Our study aims to enhance medication adherence and prospective memory using a cue-based intervention.
Aims:
To assess the improvement in prospective memory using cue-based intervention to enhance medication adherence and basic functional skills.
Objective:
- To correlate prospective memory and medication adherence with executive function and cognitive insight.
- To correlate the medication adherence with basic functional skills
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female age 18 - 60 years
- •Diagnosed with Schizophrenia as per DSM V Criteria
- •Insight of grade 3 or more.
- •At least 10th standard level of education in the English language
排除标准
- •Comorbid chronic medical illnesses.
- •Psychoactive substance use in harmful use pattern or in dependence pattern.
- •Co-existing neurodevelopmental disorders or learning disorders.
研究组 & 干预措施
Treatment as Usual
Treatment as Usual (TAU) Arm will not get any reminders but the baseline assessment will be similar to the intervention arm.
干预措施: Treatment as Usual (Behavioral)
Intervention
. The intervention arm will receive the cues in the form of daily repeating reminders for a time period of 30 days. The reminders will be set on participants' mobile phones to receive at least 1 hour prior to the prescribed oral antipsychotic medication. The same reminder will be repeated after 10 minutes duration to ensure that the participant does not miss the cue and the uniformity of the cue will be ensured by setting the same emoji or the same phrase on the participant's own mobile phone. The participant will also be asked a task of daily routine during the same time of medication.
干预措施: Cue based intervention (Behavioral)
结局指标
主要结局
Medication adherence
时间窗: Baseline, After 30days' intervention
Change in medication adherence in intervention arm as measured by Brief Adherence Rating Scale (BARS) score as compared to TAU
Prospective memory
时间窗: Baseline, After 30days' intervention
Change in prospective memory in intervention arm as measured by compared to TAU The Memory for Intentions Screening Test(MIST) score as compared to TAU
Prospective memory (sustainability)
时间窗: Baseline, 90 days after baseline assessment
Change in prospective memory in intervention arm as measured by compared to TAU The Memory for Intentions Screening Test (MIST) score as compared to TAU
Medication adherence (Sustainability)
时间窗: Baseline, 90 days after baseline assessment
Change in medication adherence in intervention arm as measured by Brief Adherence Rating Scale (BARS) score as compared to TAU
次要结局
- Cognition (Sustainability)(Baseline, 90 days after baseline assessment)
- Cognition(Baseline, After 30days' intervention)
- Independent living skills score (Sustainability)(Baseline, 90 days after baseline assessment)
- Cognitive Insight(Baseline, After 30days' intervention)
- Cognitive Insight (Sustainabilty)(Baseline,90 days after baseline assessment)
- Independent living skills score(Baseline, After 30days' intervention)
研究者
Vishwajit Nimgaonkar, MD PhD
Professor
University of Pittsburgh