- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05483478
Effectiveness of Mobile Health on Frailty, Muscle Strength and Health Literacy of the Elderly
Effectiveness of Combined Mobile Health and Multicomponent Program Intervention on Frailty, Muscle Strength and Health Literacy of the Elderly in the Community
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The current preventive and delayed disability care programs have problems such as uneven quality, number of participants, and lack of funds. During the COVID-19 epidemic, isolation measures have affected the preventive care of the elderly. More appropriate and innovative service programs should be adopted to expand Promote the prevention and delay of disability care services for the elderly in the community, so that the elderly can actively participate in their own health promotion work, reduce the occurrence of disability, shorten the number of years of disability, and enjoy a high-quality elderly life.
This study explores the effect of mobile health combined with multi-course intervention on frailty, muscle strength, health literacy and nutrition knowledge among the elderly in the community. A longitudinal, repeated test quasi-experimental design was adopted to convenient sampling. Four community care bases in northern Taiwan were selected, and 2 experimental groups and 2 control groups were assigned by computer lottery to participate in the study. 60 in the experimental group and 60 in the control group. The experimental group received the combination of mobile health and multi-course intervention, and the control group only received the intervention of multi-course. The three measurement time points of the tracking effect of the two groups were: before intervention, after 4-times interventions, and after 12-times interventions. The following data were collected in the two groups: frailty assessment, grip strength, lower limb muscle strength, health literacy scale and nutrition knowledge scale. Statistical data were analyzed by SPSS26.0 software includes: percentage, mean, standard deviation; independent sample t test, chi-square test, generalized estimation model.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Taoyuan, Taiwan, 324
- Landseed Intrenational Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ability to act independently.
- Conscious and articulate.
- Those who can communicate in Mandarin or Taiwanese.
- Smartphones and Internet access available.
- "LINE" mobile communication software can be used.
Exclusion Criteria:
- Cognitive Impaired Persons.
- mentally illness.
- Those with musculoskeletal injuries of the upper and lower limbs.
- Patients with a history of serious heart and lung diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: mobile health combined Multi-course Program
The experimental group received the combination of mobile health and multi-course intervention.
In the pre-test, the experimental group joined the LINE group by scanning the QR code.
The LINE messages were nutrition and exercise content, as well as exercise videos.
One message each for nutrition and exercise was sent every Monday, Wednesday, and Friday, for a total of 12 weeks.
The multi-course includes exercise and nutrition, 1 time per week, 2 hours each time, a total of 12 times, and each unit is 50 minutes long.
The three measurement time points of the tracking effect were: before intervention, after 4-times interventions, and after 12-times interventions.
The following data were collected in the two groups: frailty assessment, grip strength, lower limb muscle strength, health literacy scale and nutrition knowledge scale.
|
mobile health combined Multi-course Program
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ACTIVE_COMPARATOR: Multi-course Program
The control group received multi-course includes exercise and nutrition, 1 time per week, 2 hours each time, a total of 12 times, and each unit is 50 minutes long.
The three measurement time points of the tracking effect were: before intervention, after 4-times interventions, and after 12-times interventions.
The following data were collected in the two groups: frailty assessment, grip strength, lower limb muscle strength, health literacy scale and nutrition knowledge scale.
|
mobile health combined Multi-course Program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
frailty assessment
Time Frame: baseline, during the procedure, through study completion
|
Study of Osteoporotic Fractures scale was adopted。Include: (1) Weight loss: Loss of 3kg or more in the past without intentional weight loss. (2) Weakened lower extremity function: unable to stand up from a chair five times without support by hands. (3) Decreased energy: In the past week, did you feel that you couldn't get enough energy to do things? If more than two of the three items are met, frailty is defined; if one is met, the pre-frailty is defined; if not met, no frailty. |
baseline, during the procedure, through study completion
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|
muscle strength
Time Frame: baseline, during the procedure, through study completion
|
Grip machine。A practice session is given before the test to ensure that the subject understands the test process.
The hand grip strength of the elderly in Taiwan is 26 kg for men and 16 kg for women.
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baseline, during the procedure, through study completion
|
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Health Literacy
Time Frame: baseline, during the procedure, through study completion
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Mandarin Multidimensional Health Literacy Questionnaire。Each subscale has 4 questions, a total of 20 questions, and each question is scored 1-4 points.
After the formula conversion, the score is between 0-50 points.
Health awareness level 0-25 is insufficient; 26-33 is limited; 34-42 is sufficient; 43-50 is good.
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baseline, during the procedure, through study completion
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Nutrition knowledge
Time Frame: baseline, during the procedure, through study completion
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Nutrition knowledge questionnaire。There are 5 true-false questions, 5 multiple-choice questions, a total of ten questions; 1 point for a correct answer, 0 point for a wrong answer, and the score is between 0 and 10 points.
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baseline, during the procedure, through study completion
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Qing-Ping Wu, Doctor, Landseed International Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-018-A2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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