Ignite Creation Date:
2024-07-17 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474195
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-18
Brief Title:
Cue-based Intervention in Prospective Memory and Medication Adherence
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Effectiveness of Cue-based Intervention in Improving Prospective Memory by Enhancing Medication Adherence in Patients With Schizophrenia and Schizoaffective Disorder A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n52 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
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 n52 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| D43TW009114 | NIH | None | None |