| CTRI Number |
CTRI/2022/03/041005 [Registered on: 11/03/2022] Trial Registered Prospectively |
| Last Modified On: |
07/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effectiveness of a low cost generic intervention to improve quality of life for people with psychosis |
|
Scientific Title of Study
|
NIHR Research and Innovation for Global Health Transformation on Iimproving outcomes for people with psychosis in Pakistan and India- enhancing the Effectiveness of Community-based care(PIECEs) |
| Trial Acronym |
PIECEs |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 13022816 |
ISRCTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Padmavati Ramachandran |
| Designation |
Director |
| Affiliation |
Schizophrenia Research Foundation |
| Address |
Room 4 Department of Psychiatry
R/7A North Main Road
Anna Nagar West Extension Chennai
TAMIL NADU
600101
India
Chennai
TAMIL NADU
600101
India |
| Phone |
04426151073 |
| Fax |
|
| Email |
padmavati@scarfindia.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Padmavati Ramachandran |
| Designation |
Director |
| Affiliation |
Schizophrenia Research Foundation |
| Address |
Room 4 Department of Psychiatry
R/7A North Main Road
Anna Nagar West Extension Chennai
TAMIL NADU
600101
India
Chennai
TAMIL NADU
600101
India |
| Phone |
04426151073 |
| Fax |
|
| Email |
padmavati@scarfindia.org |
|
Details of Contact Person
Public Query
|
| Name |
Padmavati Ramachandran |
| Designation |
Director |
| Affiliation |
Schizophrenia Research Foundation |
| Address |
Room 4 Department of Psychiatry
R/7A North Main Road
Anna Nagar West Extension Chennai
TAMIL NADU
600101
India
Chennai
TAMIL NADU
600101
India |
| Phone |
04426151073 |
| Fax |
|
| Email |
padmavati@scarfindia.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
National Institute for Health Research |
| Address |
CENTRAL COMMISSIONING FACILITY
Grange House
15 Church Street
Twickenham
TW1 3NL |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Pakistan |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Padmavati Ramachandran |
Schizophrenia Research Foundation |
Room No 4 Department of Psychiatry
R/7a North Main Road
Anna Nagar West Extension
Chennai
Chennai
TAMIL NADU |
04426151073
padmavati@scarfindia.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of SCARF |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20-F29||Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
active control |
patients will continue to receive standard treatment including routine meetings with clinicians
To control for the addition of a tablet computer in the consultation and for repeated quality of life assessments patients will complete the DIALOG scale at the end of each session
The sessions will happen once a month for 6 months |
| Intervention |
DIALOG plus |
technology assisted resource oriented approach which includes structured patient assessment of life domain satisfaction followed by four step solution-focused therapy approach to address patient concerns. The sessions will be once a month for 6 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of psychosis
Aged over 18 years
Capacity for informed consent
Can speak and understand the local language
Has a low quality of life scoring less than 5 on the MANSA
for clinicians any professional background having regular contact with patients with psychosis |
|
| ExclusionCriteria |
| Details |
Dementia and or significant cognitive impairment and or severe learning disability
Organic psychosis or drug induced psychosis if given as the primary diagnosis
Unable to provide informed consent
clinicians who do not have regular contact with patients with psychosis and do not speak the local language |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Subjective quality of life measured using the Manchester Short Assessment of Quality of Life called MANSA |
6 months 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hospitalisation measured using the client Service resource inventory
Symptoms measured using brief psychiatry rating scale at baseline 6 months and 12 months
Negative symptoms measured using the scale for the assessment of Negative Symptoms at baseline 6 and 12 months
Objective social situation measured using the Objective Social Outcomes Index SIX at baseline 6 and 12 months
Therapeutic alliance measured using the Helping Alliance Questionnaire at baseline 6 and 12 months
Health related quality of life measured using EQ5D 3L at baseline 6 and 12 months
Service use measured using the Client Service Receipt Inventory at baseline 6 and 12 months |
6 months 12 months |
|
|
Target Sample Size
|
Total Sample Size="448"
Sample Size from India="224"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/04/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
About 5-8% of the world’s population suffer from a Severe Mental Illness (SMI), presenting a major challenge worldwide. SMI causes significant distress to affected people, families and wider communities, generating high costs through loss of productivity and ongoing healthcare use. The burden is greatest in low- and middle-income countries (LMICs), where there may be a lack of financial resources and qualified staff to provide extensive specialised services.
This study will explore, adapt and test a low-cost, generic approach (DIALOG+) that makes use of existing resources to improve community-based care for patients with psychosis and reduce the need for institutionalisation in India and Pakistan. DIALOG+ is an app-mediated intervention that has been shown to improve mental health outcomes. The research will also develop a participatory arts work that will focus on giving voice to people with psychosis and their experiences as well as engage local communities, opening conversations about mental illness.
The overall aim of the study is to test the effectiveness and cost-effectiveness of DIALOG+ in improving the quality of community-based care for patients with psychosis in India and Pakistan. The study will be conducted in India and Pakistan with 210 patients and
14 clinicians within each country. A clinician and their respective
patients will be randomly divided into two groups. The study will
involve clinicians using the app-based intervention called DIALOG+ in
their routine sessions with patients. In one group the DIALOG+ app will
be used to structure the conversation that takes place during the
session. This involves going through a patient’s satisfaction level on
various life domains and then discussing them further using a four-step
solution-focused approach. In the second group, clinicians will only use
the app to complete the satisfaction scale with patients.
Data
will be collected at baseline, at 6 months after the intervention, and
at 12 months. Data collection will include different tools to measure
quality of life, symptom severity, objective social functioning,
economic/cost-effectiveness data and health alliance. Further interviews
will take place with patients and clinicians at the end of the
intervention period (6 months) to gain a more in-depth understanding of
the experience of using DIALOG+. Data will be analysed to help the
researchers understand how effective and accepted the DIALOG+
intervention was in the sample population. |