Effect of text message reminders on treatment retention rates among outpatients with first episode psychosis: A randomized controlled trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- JIPMER
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Text message reminder intervention increases the time to dropout among patients with first episode psychosis compared to treatment as usual
Overview
Brief Summary
Eligible patients satisfying inclusion criteria will be consented for study purposes. Since this is a pilot RCT, sample size has not been calculated as it is difficult to predict the dropout rates and patients will be recruited till the end of the study period. After baseline assessment, the participants will be randomly assigned into the control and intervention groups. SMS reminders for treatment appointment and medication adherence, at a frequency described before, will be sent to the intervention group. Outcome measures such as time to drop out (primary outcome) will be assessed over the follow-up period of 6 months, along with medication adherence, functioning, and insight (secondary outcomes) at 1,3 and 6 months. For the statistical analysis, survival analysis using cox proportional hazards regression will be done with group assignment as the primary variable of interest and the following as co-variates, subject to there being at least 10 events per independent variable:
1. Distance from hospital
2. Living with parents
3. Regular employment
4. Baseline psychopathology
5. Insight
6. Substance use
7. Family emergencies
8. Education
9. Age
10. Sex
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients in the age group 18 to 40 years presenting to JIPMER with first episode of psychosis with duration of illness less than 12 months and less than four weeks of treatment with antipsychotic, antidepressant, or mood stabilizer regardless of recovery.
Exclusion Criteria
- •Caregivers without access to mobile phones
- •Caregivers who cannot read Tamil or english
- •Patients with organic psychosis
- •Psychosis due to substance use 5.
Outcomes
Primary Outcomes
Text message reminder intervention increases the time to dropout among patients with first episode psychosis compared to treatment as usual
Time Frame: 6 MONTHS
Secondary Outcomes
- Medication adherence, insight, social and occupational functioning(Baseline,1, 3 and 6 months)
Investigators
Dr Vikas Menon
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER)