Cue-based Intervention in Prospective Memory and Medication Adherence.

NCT06474195 | Active Not Recruiting

• 2 other identifiers: STUDY22120098D43TW009114
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Medication adherence is a major challenge while treating patients with major mental illnesses like schizophrenia and schizoaffective disorder. This interventional study aims to assess the improvement in prospective memory and thus medication adherence by giving time and event-based cues to the participants.

Conditions

Schizophrenia

Keywords

Adherence; Schizophrenia; Cue based

Outcome Measures

Primary Outcomes (4)

• Prospective memory

  Change in prospective memory in intervention arm as measured by compared to TAU The Memory for Intentions Screening Test(MIST) score as compared to TAU

  Baseline, After 30days' intervention

• Prospective memory (sustainability)

  Change in prospective memory in intervention arm as measured by compared to TAU The Memory for Intentions Screening Test (MIST) score as compared to TAU

  Baseline, 90 days after baseline assessment

• Medication adherence

  Change in medication adherence in intervention arm as measured by Brief Adherence Rating Scale (BARS) score as compared to TAU

  Baseline, After 30days' intervention

• Medication adherence (Sustainability)

  Change in medication adherence in intervention arm as measured by Brief Adherence Rating Scale (BARS) score as compared to TAU

  Baseline, 90 days after baseline assessment

Secondary Outcomes (6)

• Cognition

  Baseline, After 30days' intervention

• Cognition (Sustainability)

  Baseline, 90 days after baseline assessment

• Independent living skills score

  Baseline, After 30days' intervention

• Independent living skills score (Sustainability)

  Baseline, 90 days after baseline assessment

• Cognitive Insight

  Baseline, After 30days' intervention

Study Arms (2)

Intervention

EXPERIMENTAL

. The intervention arm will receive the cues in the form of daily repeating reminders for a time period of 30 days. The reminders will be set on participants' mobile phones to receive at least 1 hour prior to the prescribed oral antipsychotic medication. The same reminder will be repeated after 10 minutes duration to ensure that the participant does not miss the cue and the uniformity of the cue will be ensured by setting the same emoji or the same phrase on the participant's own mobile phone. The participant will also be asked a task of daily routine during the same time of medication.

Behavioral: Cue based intervention

Treatment as Usual

ACTIVE COMPARATOR

Treatment as Usual (TAU) Arm will not get any reminders but the baseline assessment will be similar to the intervention arm.

Behavioral: Treatment as Usual

Interventions

Cue based intervention BEHAVIORAL

The intervention arm will receive the cues in the form of daily repeating reminders for a time period of 30 days. The reminders will be set on participants' mobile phones to receive at least 1 hour prior to the prescribed oral antipsychotic medication. The same reminder will be repeated after 10 minutes duration to ensure that the participant does not miss the cue and the uniformity of the cue will be ensured by setting the same emoji or the same phrase on the participant's own mobile phone. The participant will also be asked a task of daily routine during the same time of medication.

Intervention

Treatment as Usual BEHAVIORAL

This group will not get any intervention but the usual treatment all assessments will continue

Also known as: TAU

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and Female age 18 - 60 years
• Diagnosed with Schizophrenia as per DSM V Criteria
• Insight of grade 3 or more.
• At least 10th standard level of education in the English language

You may not qualify if:

• Comorbid chronic medical illnesses.
• Psychoactive substance use in harmful use pattern or in dependence pattern.
• Co-existing neurodevelopmental disorders or learning disorders.

Sponsors & Collaborators

• University of Pittsburgh: lead
• St.John's Medical College and Hospital: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

St. John's Medical College and Hospital

Bengaluru, Karnataka, India

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Vishwajit L Nimgaonkar, MD, PhD

  University of Pittburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a randomized controlled study. The participants will be randomly assigned to treatment as usual arm or intervention arm. The intervention arm will receive the cues in the form of daily repeating reminders for a time period of 30 days. The participant will also be asked a task of daily routine during the same time of medication. The Treatment as Usual (TAU) Arm will not get any reminders but the baseline assessment will be similar to the intervention arm. There will be 2 follow-ups, 1st follow-up will be 30 days after the baseline assessment and the second will be 90 days after the baseline assessment. repeated during both follow-up visits. TAU will also be followed up at 30 days and 90 days after baseline assessment.

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 25, 2024
• Study Start: June 15, 2024
• Primary Completion: November 15, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: One year after publication of this study.
• Access Criteria: For individual participant data, meta-analysis.

Locations

IN (1)