Menu
Enrolling by invitation NCT06709027

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

No phase Interventional Patients With Depression in the Elderly

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intervention Group (Mobile Health Management Intervention).
Who it may be relevant to
Registry conditions: Patients With Depression in the Elderly. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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.

Interventions

  • 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.

Primary outcome measures

  • cognitive function [Time frame: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)]
Secondary outcome measures (5)
  • depressive symptoms [Time frame: 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)]
  • patients' quality of life [Time frame: 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)]
  • psychological needs [Time frame: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Fujian Medial University — Fuzhou

Identifiers

NCT: NCT06709027 · 2018-87 · 2018-87

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗