The Effect of Daily Living Activities Mobile Application Developed for Individuals With Chronic Mental Disorder on Functionality (RhMoGYA)

March 27, 2025 updated by: SENEM ONOL, Ege University

Daily Living Activities Mobile Application Program

The study was conducted to evaluate the functionality of a mobile application programme developed to help individuals with chronic mental disorders plan and implement their daily activities and its impact on activities of daily living.

The main questions it aims to answer are:

Does the activities of daily living mobile application programme improve participants' activities of daily living? Does the activities of daily living mobile application programme improve the activities of daily living? Does the activities of daily living mobile application programme improve participants' medication adherence?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study was conducted to evaluate the effect of a mobile application program developed to enable individuals with chronic mental disorders to plan and implement their daily activities on their functionality, daily activities, and medication adherence.

The study was designed as an experimental study with a control group, including pre-test, post-test, and follow-up measurements. A total of 64 patients with chronic mental disorders who met the inclusion criteria were included in the study, with 32 in the intervention group and 32 in the control group. Data were collected using the Introductory Information Form, the Social Functioning Assessment Scale (SFAS), the Lawton Instrumental Activities of Daily Living (IADL) Scale, and the Morisky Medication Adherence Scale (MMAS). Participants in the intervention group were administered the Activities of Daily Living-Based Mobile Application Programme developed in this study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey
        • Ege University Faculty of Medicine Hospital/ Department of Mental Health and Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: - Individuals diagnosed with schizophrenia and bipolar disorder according to DSM-V

  • Individuals aged between 18 and 65
  • I've been in treatment for the last 3 months
  • Can speak and understand Turkish
  • Open to communication and co-operation
  • Those who did not get 0 points from the phone usage step of the Lawton IADL (Lawton instrumental activities of daily living scale) data collection tool
  • Android phone owner

Exclusion Criteria:

  • Hearing, vision, speech and comprehension problems
  • Individuals who did not attend the two scheduled sessions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Experimental group

In the study, an individual-specific rehabilitation programme consisting of diagnosis, planning and intervention stages was created for the patients included in the intervention group.

In addition to routine rehabilitation services, the activities of daily living mobile application programme was applied to the intervention group in the form of face-to-face individual interviews, group training, use of RhMoGYA application by the patients for three months, and planning and follow-up of activities for the use of patients by the researcher.

The interviews were planned within the scope of the Roper Activities of Daily Living Model for the development and follow-up of patients' activities of daily living.
Other: Daily Living Activities Mobile Application
mobile application was used for three months
Other Names:
  • Experimental group
Other: Individual interviews

The individual's daily living activities are assessed using forms and scales that evaluate disability, functional level, and the ability to perform skill-based activities.

Factors affecting daily living activities, such as strengths and weaknesses, barriers, accessible healthcare services, and social support networks, are examined.

The client's independent, semi-dependent, and dependent daily living activities are evaluated together.

Implementation steps are created to achieve the identified goals. Barriers to achieving the goals and supporting factors are identified.

Other: Group education

Information is provided about the symptoms of schizophrenia and bipolar disorder, their causes, and treatment.

The early warning signs are explained, along with the importance of recognizing that they can lead to an emergency situation.

The importance of prior planning for what to do in case of an emergency is discussed. As homework, the family is asked to make this plan together.

Information is provided about the importance of daily living activities and what they entail.

Information is provided about self-care skills, healthy nutrition, movement planning, good sleep hygiene, the importance of body temperature regulation, and elimination issues.

Information is provided about communication skills. Information is given about what to pay attention to in order to establish effective communication.

Other: Routine rehabilitation program
It includes psychiatric rehabilitation services that are part of the clinic's program.
Experimental: Control group
A routine rehabilitation program has been followed
Other: Routine rehabilitation program
It includes psychiatric rehabilitation services that are part of the clinic's program.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Social Functioning Assessment Scale
Time Frame: Baseline and 5 months
The evaluation range of the scale is 19 to 57 points. High score is interpreted as high level of functionality.
Baseline and 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ege University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scientific and Technological Research Council of Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Decision No: 22-2.1T/27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD

IPD Sharing Time Frame

April 2025 - April 2026

IPD Sharing Supporting Information Type

  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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