The Canadian Depression Research and Intervention Network (CDRIN) Maritimes Registry: Reliable Assessment to Enable Research and Improve Clinical Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30,000
- 试验地点
- 1
- 主要终点
- Status Assessment: Role and Social Functioning in Adults
研究概览
简要总结
While effective interventions for depression exist, their success rates are unsatisfactory and their provision is haphazard. The Canadian Depression Research and Intervention Network (CDRIN) Maritimes Depression Hub will improve the delivery of care and the quality of outcomes for youths, adults and seniors with depression across the Maritimes. The investigators will establish an integrated system of assessment, treatment, research and education related to depression with the active involvement of those with lived experience. The establishment of a patient registry is a key step that will facilitate evaluation and reform of current services, integration of patient choice and community resources into treatment programs, monitoring long-term outcomes, and development of more effective treatment approaches through research. The registry will facilitate research that will include validation of new diagnostic and outcome measurement tools, low-cost clinical trials and collaborative projects with national and international partners. Educational programs will involve training the next generation of researchers, those with lived experience, clinicians, and health system managers in critical appraisal and will facilitate their involvement in research. The registry, the proposed systematic measurement of outcomes and the broad dissemination of information and skills will improve the quality of research and of care as well as the experience of patients and their families.
The need for a registry: It is increasingly recognized that major advances in the treatment of mental disorders will require large scale clinical research. Recently demonstrated ways of completing large-scale research with finite resources include the routine use of electronic health records (EHR), data linkage and randomized registry trial. Use of EHR is the most efficient way of rapidly obtaining large amounts of information. However, EHR cannot completely exclude confounding by indication and other unmeasured variables. Therefore, tests of treatment effects require experimental designs that cannot be replaced by routine health records data. The gold standard for testing the effects of treatment in an unbiased way is the randomized controlled trial (RCT), where measured and unmeasured confounders are balanced through the randomization process and any remaining confounding is due to chance alone. RCTs are valued as the highest level of evidence, but are costly and take significant time to be completed, partly because of the need to screen a large group of individuals to identify eligible participants.
The most efficient unbiased test of interventions, new treatment modalities and novel ways of treatment delivery is a method that combines EHR use with the randomized controlled trial (RCT) methodology: the randomized registry trial (RRT). The RRT takes advantage of a registry of individuals with available information to identify a large number of individuals suitable for an RCT. The RRT approach is efficient especially if the same information (e.g. diagnosis and treatment history) is used repeatedly for different purposes. The same information can be used for clinical purposes, service improvement and multiple research projects. RRT will allow obtaining answers about the efficacy of new treatments and management strategies significantly faster and at a much lower cost than traditional RCTs. Therefore, the investigators propose to establish a registry that has the capacity to conduct RRTs. The proposed registry will be integrated with similar efforts across Canada. Jointly, this collaborative network of registries will facilitate fast and economical testing of new treatments, which is urgently needed to advance the therapeutic options for people with depression and related conditions.
详细描述
Registry The CDRIN Maritimes registry will provide an integrated platform for clinical research and service evaluation. Participation in the registry will be offered to individuals seeking help for mental disorders across primary, secondary and tertiary care settings in Nova Scotia. In the spirit of participatory research, all participants in the registry will become members of the registry and will be kept informed of registry development, as well as educational and training opportunities. Those who have consented to be contacted regarding future research opportunities will be invited to actively participate in research.
Number of participants The number of participants in the registry is not set in advance and will depend on funding and needs of service development and research studies that will use the registry. The registry will be scalable and the investigators expect to enrol between 1000 and 30,000 participants. For the additional reliability study, numbers of participant have been determined based on a power calculation. A power calculation suggests that between 313 and 400 individuals assessed twice are required to establish the reliability of diagnostic instruments with an acceptably small measurement error (confidence interval for reliability coefficient alpha of 0.15 or smaller for disorders present in 10% of participants or more). Therefore, the investigators propose to recruit 400 individuals for the reliability study.
Inclusion and exclusion criteria The registry will be broadly inclusive with minimal exclusion criteria. Any individual who is seeking or receiving help for mental health related problems in Nova Scotia is eligible to become a member of the registry. Residents of Nova Scotia will be eligible to enter the Registry if they understand English or French and have a capacity to provide informed consent or if an appropriate substitute decision maker provides consent on their behalf. There are no exclusion criteria related to age, sex, or ethnicity. Whilst the recruitment will be targeted to include individuals suffering with depression and other types of mental illness, no specific diagnosis is required for participation in the registry. Recruitment is diagnosis-independent as the goal of the registry is to create an inclusive database of individuals seeking mental health care in the Maritimes. As such, no specific formal diagnosis is necessary. Many individuals will present at various primary, secondary, and tertiary health care settings who will not meet full diagnostic criteria for a mental health condition, but could still be sub threshold and meet diagnostic criteria at a later time. It is important to include these individuals in the registry to facilitate the clinical care of those seeking mental health care and also to facilitate research on various subsets of individuals seeking mental health care, with and without formal mental health diagnoses. Furthermore, restricting participation to people who only fulfill diagnostic criteria would not allow for testing of the reliability of the diagnosis or the boundaries between disorders and normality. Recruitment will be targeted toward individuals suffering from a potential diagnosis of Depression as it is one of the most common and burdensome mental health conditions in Canada. Participants will not be excluded from the registry if they are found to not meet diagnostic criteria following diagnostic interviews.
Participant enrollment Potential participants will be approached at the point of registration, in waiting rooms and during clinical consultations in primary, secondary and tertiary care services that are likely to serve people suffering from depression and other types of mental illness. A clinician or researcher will offer participation in the registry. After explanation of the registry purpose and the need for reliability studies, participants will provide written informed consent for their information to be kept in a registry and used for research on the causation, classification and treatment of depression and other mental disorders.
The participants will also be given the option to participate in instrument reliability studies that may include repeated completion of the same instruments.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female
- •seeking or receiving help for mental health related problems in the maritime provinces of Canada
- •able to provide informed consent or have an appropriate substitute decision maker that can provide consent on their behalf.
- •English or French speaking
排除标准
- •There are no exclusion criteria related to age, sex, or ethnicity.
- •Whilst the recruitment will be targeted to include individuals suffering with depression and other types of mental illness, no specific diagnosis is required for participation in the registry.
- •unable to provide informed consent or does not have an appropriate substitute decision maker that can provide consent on their behalf
- •does not speak English or French
结局指标
主要结局
Status Assessment: Role and Social Functioning in Adults
时间窗: 10 years
In adults, the investigators will assess current social functioning in adults with the widely used and validated clinician-rated 2-item Role and Social Functioning Scales (RSFS)
Status Assessment: General Functioning Youth
时间窗: 10 years
Current level of functioning in children and youth with the widely used and validated Columbia Impairment Scale (CIS), parent and youth report. CIS is a 13-item questionnaire that provides a global measure of impairment with scored ranging from 0 to 52. Higher scores indicate a greater level of impairment. A score of 15 or higher is considered clinically significantly impaired.
Status Assessment: Work Productivity
时间窗: 10 years
In adults, the investigators will assess current work productivity with the the self-report 11-item Lam Employment Absence and Productivity Scale (LEAPS).
Status Assessment: Work and Social Functioning
时间窗: 10 years
In adults, the investigators will assess current work and social functioning with the self-report 5-item Work and the Social Adjustment Scales (WSAS).
次要结局
- Physical health(10 years)
- Positive mood-related functioning(10 years)
- Anxiety Symptoms(10 years)
- Depression Severity(10 years)
- Anxiety Severity(10 years)
- Manic Symptoms(10 years)
- Suicidal Ideation and Behavior(10 years)
- Patient-centred outcomes(10 years)
- Depression Symptoms(10 years)
- Psychotic Symptoms(10 years)
- Side-effects of medication(10 years)
- Acceptability of and preferences for pharmacological and psychological treatments(10 years)