Effect of nurse-led dyadic intervention on treatment adherence of inpatients receiving clozapine therapy at NIMHANS, Bengaluru
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- National Institute of Mental Health and Neurosciences (NIMHANS)
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Adherence to medication
Overview
Brief Summary
PROBLEM STATEMENT
A Randomized Controlled Trial to evaluate the effect of nurse-led dyadic intervention on treatment adherence among inpatients receiving clozapine therapy admitted at NIMHANS, Bengaluru.
AIM OF THE STUDY
The research study aims to evaluate the effect of nurse-led dyadic intervention on medication adherence among patients undergoing clozapine therapy.
RESEARCH QUESTION
o How effective is a nurse-led dyadic intervention in improving medication adherence among patients undergoing clozapine therapy?
OBJECTIVES
Primary objectives
o To evaluate the effect of a nurse-led dyadic intervention on medication adherence among patients undergoing clozapine therapy.
Secondary Objectives
o To evaluate the effect of a nurse-led dyadic intervention on patient’s attitude towards medication.
o To assess the effect of the nurse-led dyadic intervention on anthropometric measures as well as, haematological and biochemical profile in patients undergoing clozapine therapy.
o To evaluate the effect of the nurse-led dyadic intervention in adherence to white blood cell monitoring among patients undergoing clozapine therapy.
o To assess the effect of nurse-led dyadic intervention on the severity of illness, quality of life, and socio-occupational functioning of patients undergoing clozapine therapy.
o To evaluate the effect of nurse-led dyadic intervention on family burden.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Inpatients o All genders o Patients diagnosed with schizophrenia and newly initiated on clozapine therapy.
- •o Between the age of 18-60 years.
- •o Patients who can understand Hindi and English.
- •o Patients accompanied by informal caregivers who will be actively involved in patient care on a day-to-day basis for at least six months.
- •Informal caregiver o All genders o Informal caregivers aged above 18 years.
- •o Informal caregivers who can understand Hindi and English o Informal caregivers who are willing to regularly monitor pill card, investigation card, communicate with the researcher by phone once in every two weeks and actively involved in management and reporting of side effects.
Exclusion Criteria
- •Patient o Patients diagnosed with co-morbid intellectual disability.
- •Informal caregiver o Informal caregivers with severe psychiatric or neurological disorders.
- •o Informal caregivers with any sensory deficits.
Outcomes
Primary Outcomes
Adherence to medication
Time Frame: Three months and six months
Secondary Outcomes
- Attitude towards medication, anthropometric measurements, haematological profile, biochemical profile, adherence to WBC monitoring, severity of illness, quality of life, socio occupational functioning, family burden(3 months and 6 months)
Investigators
Simrat Kaur
National Institute of Mental Health and Neurosciences (NIMHANS)