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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05483478
Other study ID # 21-018-A2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2021
Est. completion date June 8, 2022

Study information

Verified date August 2022
Source Landseed Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date June 8, 2022
Est. primary completion date July 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 84 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Combination Product:
mobile health combined Multi-course Program
mobile health combined Multi-course Program

Locations

Country Name City State
Taiwan Landseed Intrenational Hospital Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Landseed Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
baseline, during the procedure, through study completion
Primary 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. baseline, during the procedure, through study completion
Primary 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. baseline, during the procedure, through study completion
Primary 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. baseline, during the procedure, through study completion
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