The Construction and Application of a Mobile Health Management Program for Elderly Depression Based on the Patterns of Cognitive Function Changes

November 26, 2024 updated by: Zhu Ziping, Fujian Medical University
Based on the changing law of cognitive function, combined with the behavior change wheel theory and the health behavior process orientation model, we constructed a mobile health management program for geriatric depression. The aim is to explore the effect of this intervention program on the health behavior of elderly patients with depression; and to verify the effect of the intervention program on improving the primary outcome and other secondary outcomes of elderly patients with depression, with a view to providing a scientific basis for the management of depression in the elderly and promoting the optimization of personalized intervention strategies.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Based on the changing law of cognitive function, combined with the behavior change wheel theory and the health behavior process orientation model, we constructed a mobile health management program for geriatric depression. The aim is to explore the effect of this intervention program on the health behavior of elderly patients with depression; and to verify the effect of the intervention program on improving the primary outcome and other secondary outcomes of elderly patients with depression, with a view to providing a scientific basis for the management of depression in the elderly and promoting the optimization of personalized intervention strategies.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • 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

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350100
        • Fujian Medial University

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ① Meet the clinical diagnosis of geriatric depression and DSM-5 diagnostic criteria; ② Age ≥ 60 years old, clear consciousness; ③ Be able to communicate in Mandarin, with a certain degree of comprehension and expression; ④ Possess a smart phone and have the ability to operate it in a basic way; ⑤ Voluntarily participate in this study and sign an informed consent form

Exclusion Criteria:

  • ①previous or current cognitive impairment and other severe mental illnesses that prevent cooperation with the study;②comorbidities such as severe cardiac, hepatic, or renal impairment

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group (Mobile Health Management Intervention)
Participants in this group will receive a mobile health management intervention over a period of 12 weeks. This intervention includes the use of a mobile application designed for health management, psychological support, and monitoring，et al, with the aim of improving the mental health status of elderly patients with depression.
Device: Intervention Group (Mobile Health Management Intervention)
Participants in this group will receive a mobile health management intervention over a period of 12 weeks. This intervention includes the use of a mobile application designed for health management, psychological support, and monitoring,et al， with the aim of improving the mental health status of elderly patients with depression.
No Intervention: Control Group (Standard Care)
Participants in this group will receive standard care during the same 12-week period. This includes routine medical services and psychological support, but does not involve any specific mobile health intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive function
Time Frame: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
Using Montreal Cognitive Assessment（ MoCA） to assess patients' cognitive function
From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
depressive symptoms
Time Frame: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
sing the Geriatric Depression Scale (GDS-15) to assess patients' depressive symptoms.
From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
Behavioral Inhibition /Behavioral Activation
Time Frame: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
Using the Behavioral Inhibition System/Behavioral Activation System Scale (BIS/BAS) to assess patients' behavior.
From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
patients' quality of life
Time Frame: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
Using the WHO QOL-BREF to assess patients' quality of life.
From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
sleep quality
Time Frame: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
Using the Pittsburgh Sleep Quality Index (PSQI) to assess patients' sleep quality.
From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
psychological needs
Time Frame: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
Using the Basic Psychological Needs Scale (BPNS) to assess patients' psychological needs.
From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)

Collaborators and Investigators

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

Sponsor

Fujian Medical University

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)

August 1, 2024

Primary Completion (Estimated)

January 10, 2025

Study Completion (Estimated)

January 10, 2025

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-87 (Other Identifier: FujianMU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

2025.7.1

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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