The Application of Wearable Technology to Improve the Physical Activity Level of People With Chronic Mental Illness

Kaohsiung Medical University

Status: Completed

Conditions: Physical Activity; Schizophrenia; Health Knowledge, Attitudes, Practice

Treatments: Behavioral: LINE group; Device: Wearable technology; Behavioral: Group activities; Device: Health promotion manual

Study type: Interventional

Funder types: Other

Identifiers

NCT03408327

KMUHIRB-SV(I)-20150091

Details and patient eligibility

About

The object is to develop a physical activity promotion program by applying social cognitive theory and wearable technology and evaluate its feasibility in people with MI

Stage I: Accuracy, Acceptability, Feasibility. Stage II: Effectiveness Analysis

In stage II, will conduct a single-blinded, randomized controlled study. 90 participants will be randomly assigned to experimental group or control group. The intervention for both groups will last for 12 weeks, with a 12-week of follow-up. The measurements include physical activity level, physical fitness, cognitive function and sleep quality, as well as the moderators of the effectiveness of program.

Full description

Background: The health condition of individuals with chronic mental illness (MI) is usually poorer than the general population. This health disparity may be related to their lower physical activity level. One of the critical issues in psychiatric rehabilitation is to develop a health promotion program which utilizes less clinical resources and results in long-term effectiveness. Compared with structure exercise, lifestyle physical activity might be one of the solutions. With the mobile technology and wearable technology becoming popular, mobile health (mHealth) emerges and has showed some preliminary effects on other population. The mHealth may be an innovative health promotion program for people with MI and deserves more research to examine the effectiveness.

Purpose: This study is (1) to examine the accuracy and acceptability of wearable technology in persons with MI; (2) to develop a physical activity promotion program by applying social cognitive theory and wearable technology and evaluate its feasibility in people with MI ; (3) to examine the effectiveness of the program on physical activity level and health outcomes ; and (4) to examine the moderators of the program's effectiveness.

Methods:

Stage I: completed (Accuracy, Acceptability, Feasibility) Stage II: (RCT) The investigators will conduct a single-blinded, randomized controlled study. 90 participants will be randomly assigned to experimental group or control group. The intervention for both groups will last for 12 weeks, with a 12-week of follow-up. The measurements include physical activity level, physical fitness, cognitive function and sleep quality, as well as the moderators of the effectiveness of program.

Contributions: The results of study will be one of the evidence-based health promotion programs for individuals with MI. With wearable technology and telecommunication technology, it makes possible to expand the health care services from traditional clinical settings to client's natural milieu, and to serve more people with MI by using less resources. The results of study may also form a much appreciated basis for future studies of mHealth on other heath behavior (e.g., healthy diet) or in other disability groups (e.g., stroke).

Enrollment: 50 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. having a diagnosis of SMI (including schizophrenia, depression, and bipolar disorder over one year) made by a psychiatrist on the basis of the criteria set Diagnostic and Statistical Manual of Mental Disorders, 5th edition, text-revision, DSM-V
2. living in the community and receiving community-based mental health rehabilitation services
3. having stable psychiatric conditions (i.e., primary psychiatric medications had not changed for more than two months)
4. being 20 to 64 years old
5. No obvious cognitive impairment (Mini-Mental Status Exam >24)
6. can follow the research process and sign the consent

Exclusion criteria

1. having a clinically significant physical condition making it unsafe to increase daily walking activity, such as severe coronary heart disease or musculoskeletal problems
2. according participants' self-statement, having following illness, including severe heart failure,myocardial infarction, angina pectoris, chronic obstructive pulmonary disease, COPD, poor glycemic control (i.e., dialysis, diabetic neuropathy or retinopathy) and lower extremity arthritis
3. uncontrolled hypertension with SBP> 160 mmHg or DBP> 110 mmHg
4. has significant cognitive impairment
5. unconscious or confused
6. already exercising regularly (i.e., doing moderate-intensity physical activities for 150 minutes each week)
7. participating in other intervention studies

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Experimental group

Experimental group

Description:

1. Wearable technology (fitness wristband \& App) 2. 4 times group activities (2 hr / each times) 3. LINE group interaction 4. Reminder and feedback form researcher

Treatment:

Behavioral: Group activities

Device: Wearable technology

Behavioral: LINE group

Control group

Active Comparator group

Description:

1. Wearable technology (fitness wristband + App) 2. Health promotion manual

Treatment:

Device: Health promotion manual

Device: Wearable technology