跳至主要内容
临床试验/NCT02895269
NCT02895269已完成不适用

Partnership for Mental Health Development in Sub-Saharan Africa: COllaborative Shared Care to IMprove Psychosis Outcome

University of Ibadan2 个研究点 分布在 2 个国家目标入组 307 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
307
试验地点
2
主要终点
Reduction in symptoms of psychosis

研究概览

简要总结

COSIMPO is a randomised controlled trial in which a collaborative shared care for psychosis implemented by complementary alternative providers (traditional and faith healers) and conventional primary health care providers (PHCP) is compared with care as usual in which no formal collaboration takes place between the two groups of health providers. COSIMPO is therefore a test of a complex task sharing approach for the care of patients with severe mental disorders.

详细描述

Most patients with psychotic disorders receive care from traditional and faith healers (complementary alternative providers, CAPs) in the setting of COSIMPO (Nigeria, Ghana). Treatment modalities by the healers include the use of herbs and rituals but may also involve potentially harmful practices such as shackling and scarification. The objective of COSIMPO is to compare the effectiveness of a collaborative shared care program between the CAPs and PHCP in improving the outcome of patients with psychosis under the care of CAPs facilities compared with that of usual care. A cluster randomized control trial design is implemented in Nigeria and Ghana. Patients in the control arm receives usual care enhanced through the training of PHCP in the arm, but no structured or formal collaboration is implemented.

Primary hypothesis: Patients presenting to CAPs facilities engaged in collaborative shared care with PHCP will have better outcome of psychosis compared to patients in enhanced usual care at 6 months following entry into the trial as measured by a significant mean reduction in symptoms as rated with the Positive and Negative Syndrome scale (PANSS). For the purpose of this study, a 7-point difference on the PANSS total outcome scores between the two groups will be regarded as a clinically meaningful difference.

Secondary hypotheses:

  1. Persons with psychosis receiving treatment from CAPs in the collaborative care program will be less likely to receive harmful treatment or be subject to human rights abuses (such as chaining, beating, starving, scarification, isolation, forced and prolonged fasting) than those receiving care as usual.
  2. Persons in the intervention arm will be less likely to experience victimization and abuse from caregivers. Victimisation is defined as an act or action that exploits or treats a patient unfairly.
  3. The patients in the intervention arm will have significantly less disability than those in the control arm
  4. The providers (both CAPs and PHCPs) in the collaborative care program will have better attitudes to and knowledge of psychosis than those in the (enhanced) care as usual.
  5. Collaborative share care will be more cost effective than usual care. Setting and location of RCT Nigeria: The study site in Nigeria is Ibadan, one of the largest cities in Africa. The inhabitants are mostly Yoruba with a mix of religious practices being prevalent. Ibadan is a cosmopolitan city with five of its eleven local governments (districts) being urban while the remaining six are rural or semi-urban. The population of Ibadan as of the last census in 2006 was 1,338,659, (Census 2006). There are on the average about 10 PHCs in each of the local governments and traditional health practice facilities are ubiquitous. All eleven local government areas in and around Ibadan are included in the study

Ghana: The Ashanti Region is located in south Ghana and third largest of 10 administrative regions. With a population of 3,612,950, the region accounts for 19.1 percent of Ghana's total population (2010 census) (Awuah-Nyamekye, Samuel, and Paul Sarfo-Mensah, 2012). Seven districts were selected for the study in Ashanti on the basis of having the size of population required for the study and being accessible to the research center.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

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

  • Patients aged 18 and over and who speak the study language of Yoruba (Nigeria) or Kwi (Ghana). Only patients who speak the languages of the study will be included.
  • All patients presenting to the CAPs in the selected clusters with a confirmed diagnosis of non-organic psychosis as assessed by research interviewers using the Structured Clinical Interview for DSM (SCID).
  • Patients must be on admission at the CAP facility and must be symptomatic at the time of recruitment as indicated by a minimum total PANSS score of
  • Patients must have a caregiver who is willing to give consent to participate in the study.

排除标准

  • Those with serious physical illness in need of urgent medical attention (this could be a serious infection, injury, etc.).
  • Serious cognitive impairment that may interfere with assessment by the research team.
  • Those who will not be in the study area for at least six month following recruitment.
  • Women who are pregnant or will attempt to become pregnant during the study period.

研究组 & 干预措施

Collaborative shared care

Experimental

Conventional primary health care providers (PHCP) are trained to collaborate with and support traditional and faith healers (complementary alternative providers, CAPs) in the care of patients with psychosis. The PHCP are purposively trained to deliver evidence-based treatment for psychosis and to conduct scheduled and on-request visits to the facilities of the CAPs to collaborate in the treatment of patients with psychosis through joint decision making and clinical management. The overall care of the patients remains the responsibility of the healers. The role of the PHCP is to support the healers deliver safe and acceptable care to patients, including the promotion of and respect for human rights and avoidance of harmful practices in the care of patients.

干预措施: Collaborative shared care (Behavioral)

Usual care

Active Comparator

Complementary alternative providers deliver intervention for patients with psychosis without active or formal collaboration with conventional primary health care providers. The primary health care providers in this arm nevertheless receive training on evidence-based treatment of psychosis.

干预措施: Collaborative shared care (Behavioral)

结局指标

主要结局

Reduction in symptoms of psychosis

时间窗: 6 months

The primary outcome will be improvement of psychosis as determined by a 7-point difference on the PANSS total scores between the two groups at 6 months after study entry, controlling for baseline scores.

次要结局

  • Harmful treatment practices(3,and 6 months)
  • Disability(3, and 6 months)
  • Stigma(3,and 6 months)
  • Victimisation(3, and 6 months)

研究者

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

Prof Oye Gureje

Professor of Psychiatry

University of Ibadan

研究点 (2)

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