Elderly Clinical Trial
Official title:
Effectiveness of Combined Mobile Health and Multicomponent Program Intervention on Frailty, Muscle Strength and Health Literacy of the Elderly in the Community
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 |
Verified date | August 2022 |
Source | Landseed Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Landseed Intrenational Hospital | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Landseed Hospital |
Taiwan,
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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