Investigating physical comorbidity in people with severe mental illness in South Asia
| ISRCTN | ISRCTN88485933 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88485933 |
| Secondary identifying numbers | 002 |
- Submission date
- 22/05/2019
- Registration date
- 03/06/2019
- Last edited
- 15/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
People with mental illness die on average 10-20 years earlier than the general population. Studies from low- and middle-income countries also show a similar pattern but with an even greater reduction in life expectancy.
The vast majority of these excess deaths are due to preventable physical health problems, such as heart disease and diabetes. Almost all physical conditions are more common and their outcomes are poorer for people with mental illness. Reasons for this include a complex combination of the underlying mental disorder, its treatment, socioeconomic inequalities and crucially, disparities in accessing healthcare and lack of effective treatments.
The physical health of people with mental illness has been largely neglected by health professionals. For example, they do not receive screening for health problems, do not get illnesses such as diabetes diagnosed, or get help to stop smoking. To compound the problem, there has been limited research in this area. Current gaps in knowledge and availability of effective treatments for physical health problems in people with mental illness are simply indefensible and contravene their basic human right to health.
Responding to this complex challenge requires strong international research partnerships and collaborations. We have established a collaboration between policy makers, clinicians and researchers from the UK and South Asia (Bangladesh, India and Pakistan) – the IMPACT Group. The aim is to develop expertise and carry out research to understand how to prevent physical health problems, improve health and improve health services for one of the world’s most vulnerable populations- people with mental illness in South Asia.
Who can participate?
Anyone aged 18 or over with a diagnosis of severe mental illness (i.e. schizophrenia, schizoaffective disorder, bipolar affective disorder, severe depression with psychosis), attending included institutions during the study period can participate.
What does the study involve?
Participants will be interviewed about their health and lifestyle.
What are the possible benefits and risks of participating?
As a non-interventional study, there is very little risk of adverse events associated with the study. Due to the frailty of the population, some questions or the burden of the assessments may cause distress on the participants or the carers. However, if any of these happens, the participant can stop participating at any time during the assessments.
If a physical condition or blood test abnormality (outside the normal range for age and sex) is detected as a part of the research assessments, the research team will inform the clinician responsible for the patient.
Where is the study run from?
1. The National Institute of Mental Health and Neuro-Sciences, Bangalore, India
2. National Institute of Mental Health, Dhaka, Bangladesh
3. Institute of Psychiatry & WHO Collaborating Center, Rawalpindi, Pakistan
When is the study starting and how long is it expected to run for?
July 2019 to December 2020
Who is funding the study?
National Institue of Health Research, UK
Who is the main contact?
Dr Gerardo Zavala Gomez,
g.zavala@york.ac.uk
Contact information
Public
Room 208a
ARRC building
University of York
York
YO1 6JP
United Kingdom
 ORCID ID |
0000-0002-9825-8725 |
|---|---|
| Phone | 01904321333 |
| g.zavala@york.ac.uk |
Study information
| Study design | Cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Investigating mental and physical comorbidity: survey in people with severe mental illness in South Asia |
| Study acronym | IMPACT SMI survey |
| Study objectives | The prevalence of physical disorders and related lifestyle health risk behaviours in people with severe mental illness (SMI) in South Asia is higher than in the general population. |
| Ethics approval(s) | 1. Approved 02/08/2017, Health Sciences Research Governance Committee from the University of York (Heslington, York, YO10 5DD; (01904) 323253; smh12@york.ac.uk), ref: nil known 2. Approval pending, National Centre for Injury Prevention and Rehabilitation Bangladesh (House: B 162, Rd No 23, Dhaka, Bangladesh; +880 2-58814988; info@ciprb.org), ref: nil known 3. Approval pending, Indian Medical Research Council (P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India; 91-11-26588980; icmrhqds@sansad.nic.in), ref: nil known 4. Approved 19/09/2018, National Bioethics Committee Pakistan (Institutional research and ethics forum, Rawalpindi medical university, Tipu Rd, Chamanzar Colony, Rawalpindi, Punjab 46000, Pakistan; +92 51 9290755; info@rmur.edu.pk), ref: R-32/RMU/20 |
| Health condition(s) or problem(s) studied | Severe mental illness |
| Intervention | We will conduct a cross-sectional survey among SMI patients in wards, outpatient clinics and specialist mental health institutions in Bangladesh, India and Pakistan. In Bangladesh, the survey will take place initially at the National Institute of Mental Health (NIMH), Dhaka. In India, the survey will be conducted initially at the National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, a tertiary care neuropsychiatric institute. In Pakistan, the survey will be initiated at Institute of Psychiatry (IoP), Rawalpindi. Once the procedures and resource requirements have been established in the three sites, the survey will expand to other specialist mental health institutes. |
| Intervention type | Other |
| Primary outcome measure | Prevalence of self-reported communicable and non-communicable diseases and lifestyle health-risk behaviors measured by patient interviews at baseline. |
| Secondary outcome measures | Identify lifestyle advice, health-related quality of life and common mental disorders (depressive and anxiety symptoms) measured by patient interviews at baseline |
| Overall study start date | 01/05/2018 |
| Completion date | 01/03/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 4,500 |
| Total final enrolment | 3989 |
| Key inclusion criteria | 1. Diagnosis of severe mental illness (i.e. schizophrenia, schizoaffective disorder, bipolar affective disorder, severe depression with psychosis) 2. Aged 18 years and over 3. Able to provide informed consent, or for whom carer agreement can be obtained 4. Attending included institutions during the study period 5. Able to be seen by study researchers during working hours |
| Key exclusion criteria | Patients who are assessed to lack capacity by their local physician |
| Date of first enrolment | 01/07/2019 |
| Date of final enrolment | 01/12/2020 |
Locations
Countries of recruitment
- Bangladesh
- India
- Pakistan
Study participating centres
Someshwara Nagar
Jayanagar
Bengaluru
560029
India
Near Shyamoli Sheeshu Mela
Dhaka
1207
Bangladesh
Chah Sultan
Rawalpindi
46000
Pakistan
Sponsor information
University/education
Heslington
York
YO10 5DD
England
United Kingdom
| Phone | 01904321333 |
|---|---|
| michael.barber@york.ac.uk | |
| Website | https://www.york.ac.uk/ |
"ROR" |
https://ror.org/04m01e293 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The protocol of the survey will be sent for publication The second manuscript of the survey will be a prevalence study addressing the physical h Physical co-morbidities in patients with severe mental illness in south Asia: a cross-sectional study in India Pakistan and Bangladesh. Exploring the inequalities, sex, age and country related differences in the prevalence. The third will provide an overview of the prevalence of “unhealthy behaviours” (i.e. smoking, alcohol consumption, physical activity, sleeping patterns) and study the relationship between modifiable lifestyle behaviours, and their relationship with infectious and non-communicable diseases in South Asia. The fourth will explore the experiences of seeking healthcare (including out of pocket expenditure) for physical health problems and b) the offer, receipt and engagement with lifestyle behaviour change interventions for this group. |
| IPD sharing plan | The datasets generated during the current study will be available upon request from the IMPACT data management group. Ownership of the data is carefully managed, in accordance with the IMPACT Collaboration Agreement (between the partners) and the Main Contract (between the University of York, as the co-ordinator, and the NIHR, as funder) and IP policy. Guidance and regulations governing the collection and secure storage of research data at participating organisations and the University of York will be followed. Consent will be provided by all participants. All consent forms will be stored separately from survey data in locked cabinets in locked offices at study research offices in each study site. All coded data will be transferred to and stored as anonymous data at the University of York who will act as data curator. A secure password protected and encrypted electronic database will be set up to store the data. All trackable information records will be destroyed at the end of the standard archiving period (i.e. 10 years after study approval) in line with the University of York policies. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 10/10/2020 | 13/10/2020 | Yes | No |
| Results article | 23/02/2023 | 19/07/2023 | Yes | No | |
| Results article | 14/12/2023 | 15/12/2023 | Yes | No |
Editorial Notes
15/12/2023: Publication reference added.
19/07/2023: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
13/10/2020: Publication reference added.
07/06/2019: Internal review.
30/05/2019: Trial’s existence confirmed by University of York.
