Cue-based Intervention in Prospective Memory and Medication Adherence.

NCT ID: NCT06474195

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-15
• Study Completion Date: 2025-12-31

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.

Detailed Description

According to available evidence, prospective memory (PM) is important in daily functioning but is impaired in schizophrenia. However, there were hardly any Indian studies on this topic. Medication adherence is one of the challenges which clinicians often face during treatment. Our study aims to enhance medication adherence and prospective memory using a cue-based intervention.

Aims:

To assess the improvement in prospective memory using cue-based intervention to enhance medication adherence and basic functional skills.

Objective:

1. To correlate prospective memory and medication adherence with executive function and cognitive insight.

2. To correlate the medication adherence with basic functional skills

Hypotheses to be tested:

1. Statistically significant difference between prospective memory improvement with intervention in the intervention group and treatment as usual group.

2. A Statistically significant correlation between prospective memory score and medication adherence score.

3. A Statistically significant correlation between medication adherence and basic functional skills.

The study will have two arms with two arms (n=52 in each group) the intervention arm and the TAU arm. Participants in both arms will receive standard medical care as advised by the treating psychiatrist. The treating psychiatrist will be blinded about which group the patient belongs to and they will be encouraged to prescribe stable medication throughout the study process unless it would affect the treatment outcome or prognosis of the patient. 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 phone to receive at least 1 hour prior to the prescribed oral antipsychotic medication. The same reminder will be repeated after 10minutes duration to ensure that 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 participants own mobile phone. The participants will also be encouraged to close their eyes for 5-7 seconds and imagine themselves to be taking the medication at the prescribed time when they see the reminder. The family members or the caretaker of the patient will be provided with a adherence chart which will be reviewed during the follow up visits. During the baseline assessment Independent Living Skills Survey (ILSS) questionnaire will be administered to obtain a baseline score of living skills and the domain with least score will be addressed by individual based intervention using similar cue-based intervention by repeated reminders will be done to improve that domain and during the follow up visit the improvement will be assessed by comparing the follow up scores of (ILSS) with baseline scores. Subsequently on first follow up the medication adherence will be assessed using Brief Adherence Rating Scale (BARS) and prospective memory will be assessed using Memory for Intentions Screening Test (MIST) and the score will be briefed to the patients and patients will be motivated to comply with study process till the second follow up. The second follow up assessment will be done after 90 days from baseline assessment. During the time period between first and second follow up the participants will not receive any cue. Participants will be assessed using Memory for Intentions Screening Test (MIST), Brief Adherence Rating Scale (BARS), Trail Making Test (TMT), Beck Cognitive Insight Scale (BCIS) and Independent Living Skills Survey (ILSS) during baseline, first follow up and second follow up. During each sessions patients as well as family will be enquired if they suffered from any distress related to the study, both psychological and physical. In that case it will be explored in detail and if required necessary intervention will be given after after consulting with the treating psychiatrists.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

. 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.

Group Type: EXPERIMENTAL

Cue based intervention

Intervention Type: 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.

Treatment as Usual

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

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: BEHAVIORAL

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

Interventions

Cue based intervention

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 Type: BEHAVIORAL

Treatment as Usual

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

Intervention Type: BEHAVIORAL

Other Intervention Names

TAU

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role: collaborator

St.John's Medical College and Hospital

UNKNOWN

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Vishwajit Nimgaonkar, MD PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vishwajit L Nimgaonkar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittburgh

Locations

St. John's Medical College and Hospital

Bengaluru, Karnataka, India

Site Status: RECRUITING

Countries

India

Central Contacts

Vishwajit L Nimgaonkar, MD, PhD

Role: CONTACT

vishwajitnl@upmc.edu

4127265164

Triptish Bhatia, PhD

Role: CONTACT

trb16@pitt.edu

+919910107210

Facility Contacts

Milan Varghese, MD

Role: primary

milanvarghese25@gmail.com

+918547514033

Other Identifiers

D43TW009114

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY22120098

Identifier Type: -

Identifier Source: org_study_id