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

NCT ID: NCT06709027

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-01-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Patients With Depression in the Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study employs a parallel assignment design where participants are randomly assigned to either the experimental group receiving Mobile Health Management Intervention or the control group receiving a standard treatment. The study is single-blind, meaning participants are unaware of which group they belong to, thus minimizing potential bias. Data will be collected at regular intervals to evaluate the efficacy and safety of the intervention.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Intervention Group (Mobile Health Management Intervention)

Intervention Type DEVICE

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Zhu Ziping

Fujian Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fujian Medial University

Fuzhou, Fujian, China

Site Status

Countries

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China

Other Identifiers

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2018-87

Identifier Type: OTHER

Identifier Source: secondary_id

2018-87

Identifier Type: -

Identifier Source: org_study_id