Application of Monitoring and Intervention Technologies in Suboptimal Health Status

Chinese PLA General Hospital (301 Hospital)

Status: Completed

Conditions: Suboptimal Health Status; Metabolic Abnormality

Treatments: Device: meridian therapy instrument; Device: monitoring device; Other: health information push technology

Study type: Interventional

Funder types: Other

Identifiers

NCT02441010

2012BAI37B04-05

Details and patient eligibility

About

The purpose of this study is to use monitoring and intervention technologies in suboptimal health status in a general population in China and evaluate the effectiveness of these technologies in the improvement of suboptimal health status.

Full description

The Suboptimal health status questionnaire (SHSQ-25) is used to evaluate the suboptimal health status. The SHSQ-25 includes 25 questions. The score of the SHSQ-25 is from 0 to 100. Suboptimal health status is defined as the SHSQ-25 score above than 35. The higher scores of the SHSQ-25 one gets, the more severity of suboptimal health status he/she has. All participants are asked to fill in the SHSQ-25 before and after the intervention. If the score decreases after the intervention, it means that the suboptimal health status has been improved.

A monitoring device is used to monitor a person's blood pressure, blood glucose, oxygen saturation, body weight, and energy consumption by Bluetooth Wireless technology. Intervention technologies include a health information push technology and a field-effect meridian therapy instrument.

Enrollment: 2,014 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. age between 18 and 60 years.
2. written informed consent.

Exclusion criteria

1. history of system diseases, such as cardiovascular diseases, digestive system diseases, diseases of respiratory system, blood and immune system diseases, nervous system diseases, endocrine system diseases, and diseases of the genitourinary system.
2. history of mental illness.
3. pregnant or breastfeeding.
4. use of antihypertensive, antidiabetic, or lipid-lowering drugs within the past two weeks.
5. participation in another trial.
6. unable to promise to not use drugs and other fish oils during the study.
7. unable to provide informed written consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,014 participants in 7 patient groups

Group 1

No Intervention group

Description:

Participants without suboptimal health status are randomly grouped into the group without monitor (Group 1) and the monitor group (Group 2 or Group 3). Thus, no monitoring or intervention technologies are used in Group 1.

Group 2

Sham Comparator group

Description:

Group 2 are participants without metabolic abnormality in the monitor group. Group 2 use the monitoring device with three months.

Treatment:

Device: monitoring device

Group 3

Sham Comparator group

Description:

Group 3 are participants with metabolic abnormality in the monitor group. Group 3 use the monitoring device and the health information push technology with three months.

Treatment:

Other: health information push technology

Device: monitoring device

Group 4

Active Comparator group

Description:

All of participants with suboptimal health status use the monitoring device with three months, and are randomly grouped into the non-intervention group (Group 4 or Group 5) and the intervention group using the meridian therapy instrument (Group 6 or Group 7). Group 4 are participants without metabolic abnormality in the non-intervention group. No intervention technologies are used in Group 4.

Treatment:

Device: monitoring device

Group 5

Active Comparator group

Description:

Group 5 are participants with metabolic abnormality in the non-intervention group. Group 5 use the health information push technology with three months.

Treatment:

Other: health information push technology

Device: monitoring device

Group 6

Experimental group

Description:

Group 6 are participants without metabolic abnormality in the intervention group. Group 6 use the meridian therapy instrument with two weeks. If the suboptimal health status is not improved, then the meridian therapy instrument will continue to be used with an interval of one week.

Treatment:

Device: monitoring device

Device: meridian therapy instrument

Group 7

Experimental group

Description:

Group 7 are participants with metabolic abnormality in the intervention group. Group 7 use the health information push technology with three months and the meridian therapy instrument with two weeks. Similar with Group 6, if the suboptimal health status is not improved after the treatment of the meridian therapy instrument, then the instrument will continue to be used with an interval of one week.

Treatment:

Other: health information push technology

Device: monitoring device

Device: meridian therapy instrument