Patients With Depression in the ElderlyNCT06709027
The Construction and Application of a Mobile Health Management Program for Elderly Depression Based on the Patterns of Cognitive Function Changes
A study testing Intervention Group (Mobile Health Management Intervention) in people with Patients With Depression in the Elderly, run by Fujian Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Patients With Depression in the Elderly
- What is being tested?
- Intervention Group (Mobile Health Management Intervention)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Patients With Depression in the Elderly
- Being tested
- Intervention Group (Mobile Health Management Intervention)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Group (Mobile Health Management Intervention)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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Mobile Health Management Intervention) | Experimental | 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. Receives: Device: Intervention Group (Mobile Health Management Intervention) |
| Control Group (Standard Care) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
cognitive function
Using Montreal Cognitive Assessment（ MoCA） to assess patients' cognitive function
Measured: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
Secondary outcomes (5)
depressive symptoms
sing the Geriatric Depression Scale (GDS-15) to assess patients' depressive symptoms.
Measured: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
Behavioral Inhibition /Behavioral Activation
Using the Behavioral Inhibition System/Behavioral Activation System Scale (BIS/BAS) to assess patients' behavior.
Measured: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
patients' quality of life
Using the WHO QOL-BREF to assess patients' quality of life.
Measured: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
sleep quality
Using the Pittsburgh Sleep Quality Index (PSQI) to assess patients' sleep quality.
Measured: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
psychological needs
Using the Basic Psychological Needs Scale (BPNS) to assess patients' psychological needs.
Measured: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Aug 2024
- Primary completion10 Jan 2025 (estimated)
- Study completion10 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Depression in the ElderlyStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Ziping, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709027
- Sponsor's protocol ID
- 2018-87
- Other IDs
- 2018-87
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 2025.7.1
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Construction and Application of a Mobile Health Management Program for Elderly Depression Based on the Patterns of Cognitive Function Changes
- ClinicalTrials.gov ID
- NCT06709027
- Acronym / sponsor ID
- 2018-87
- Conditions
- Patients With Depression in the Elderly
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 10 Jan 2025 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Mobile Health Management Intervention) | Experimental | 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. |
| Control Group (Standard Care) | No intervention | –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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) |
Primary outcome
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
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: Yes. 2025.7.1
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group (Mobile Health Management Intervention) in people with Patients With Depression in the Elderly, run by Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive function (time frame: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.