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Effectiveness of Mobile Health on Frailty, Muscle Strength and Health Literacy of the Elderly

Primary Purpose

Telemedicine, Elderly, Health Literacy

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
mobile health combined Multi-course Program
Sponsored by
Landseed Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Telemedicine focused on measuring mobile health, frailty, health literacy, muscle strength

Eligibility Criteria

65 Years - 84 Years (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Landseed Intrenational Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mobile health combined Multi-course Program

Multi-course Program

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

frailty assessment
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.
muscle strength
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.
Health Literacy
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.
Nutrition knowledge
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.

Secondary Outcome Measures

Full Information

First Posted
July 28, 2022
Last Updated
August 1, 2022
Sponsor
Landseed Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05483478
Brief Title
Effectiveness of Mobile Health on Frailty, Muscle Strength and Health Literacy of the Elderly
Official Title
Effectiveness of Combined Mobile Health and Multicomponent Program Intervention on Frailty, Muscle Strength and Health Literacy of the Elderly in the Community
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
June 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Landseed Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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. Descriptive statistics include: percentage, mean, standard deviation; inferential statistics include: independent sample t test, chi-square test, generalized estimation model.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telemedicine, Elderly, Health Literacy
Keywords
mobile health, frailty, health literacy, muscle strength

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mobile health combined Multi-course Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Multi-course Program
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
mobile health combined Multi-course Program
Intervention Description
mobile health combined Multi-course Program
Primary Outcome Measure Information:
Title
frailty assessment
Description
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.
Time Frame
baseline, during the procedure, through study completion
Title
muscle strength
Description
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.
Time Frame
baseline, during the procedure, through study completion
Title
Health Literacy
Description
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.
Time Frame
baseline, during the procedure, through study completion
Title
Nutrition knowledge
Description
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.
Time Frame
baseline, during the procedure, through study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qing-Ping Wu, Doctor
Organizational Affiliation
Landseed International Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Landseed Intrenational Hospital
City
Taoyuan
ZIP/Postal Code
324
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Mobile Health on Frailty, Muscle Strength and Health Literacy of the Elderly

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