Assessing the Feasibility and Impact of Physical Health Monitoring in Patients with First Episode Psychosis (AIIMS centre)
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- SAPS,SANS, YMRS, MADRS,BPRS, GAF, SOFAS, EQ 5 D 5L, Assessment of Physical Health Checklist
研究概览
简要总结
It is a multicentric multicountry project funded by National Institute for Health Research, UK titled multicentric multicountry project funded by National Institute for Health Research, UK titled “NIHR Global Health Research Group on Psychosis Outcomes: the Warwick-India- Canada (WIC) Network, The University of Warwickâ€.The objectives of the project at AIIMS center are to determine prevalence of cardiometabolic risk factors such as metabolic syndrome, insulin resistance, prediabetes in a cohort of FEP patients and to assess feasibility and acceptability of using mobile app and booklet based psychosocial intervention protocols in patients with FEP in promoting adherence to healthy lifestyle and impact on outcomes (psychopathology, food taking patterns, physical activity and physical health parameters, functioning and quality of life).The Project aims to improve the physical health, wellbeing and functioning, and reduce the burden for patients with first episode psychosis. It aims to do this by applying using mobile app and booklet based psychosocial intervention protocols in patients with FEP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 14.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria for Patient ï‚· First presentation with psychotic symptoms at our centre ï‚· Age 14-45 years ï‚· No past history of psychosis ï‚· Not received treatment ≥ 3 months ï‚· Either sex ï‚· Schizophrenia (F20), persistent delusional disorder (F22), acute and transient psychotic disorders (F 23), Schizo-affective disorder (F25), Other and Unspecified Psychosis (F28 & F29), Mania with psychotic symptoms (F30.2), Bipolar affective disorder, current episode manic with psychotic symptoms (F 31.2), Severe depressive episode with psychotic symptoms (F32.3) and Recurrent Depressive Disorder, current episode depression with psychotic symptoms (F 33.3) on ICD-10 (WHO 1993).
- •Inclusion criteria for Caregiver A family member staying with patient and fulfilling any three of the following criteria (Maji et al, 2012): ï‚· Parent or spouse ï‚· Had most frequent contact with the patient ï‚· Helped to support the patient financially ï‚· Had most frequently been a participant in patient’s treatment ï‚· To be contacted by treatment staff in case of an emergency.
排除标准
- •Exclusion criteria for Patient ï‚· Presence of pervasive developmental disorder, specific learning disability and mental retardation (ascertained on history and clinical examination) ï‚· Presence of organic brain damage, epilepsy (ascertained on history and clinical examination) ï‚· Not willing or able to provide informed consent Exclusion criteria for Caregivers ï‚· Not willing/or able to provide informed consent.
结局指标
主要结局
SAPS,SANS, YMRS, MADRS,BPRS, GAF, SOFAS, EQ 5 D 5L, Assessment of Physical Health Checklist
时间窗: baseline, 1 month, 3 month
Weight, Height, BMI, Waist Circumference, Hip Circumference, Waist–to-Hip Ratio, Blood Pressure
时间窗: baseline, 1 month, 3 month
-Laboratory Investigations: ECG, haematology, liver function test, kidney function test, urine examination (for proteinuria and microalbuminuria), lipid profiling, fasting glucose and fasting insulin ( for Insulin Resistance ), HbA1C
时间窗: baseline, 1 month, 3 month
次要结局
- Food taking patterns(Feasibility performa)