NCT05483478

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2021

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
Last Updated

August 2, 2022

Status Verified

August 1, 2022

Enrollment Period

16 days

First QC Date

July 28, 2022

Last Update Submit

August 1, 2022

Conditions

Keywords

mobile healthfrailtyhealth literacymuscle strength

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

mobile health combined Multi-course Program

EXPERIMENTAL

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.

Combination Product: mobile health combined Multi-course Program

Multi-course Program

ACTIVE COMPARATOR

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.

Combination Product: mobile health combined Multi-course Program

Interventions

mobile health combined Multi-course Program

Multi-course Programmobile health combined Multi-course Program

Eligibility Criteria

Age65 Years - 84 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Landseed Intrenational Hospital

Taoyuan District, 324, Taiwan

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Qing-Ping Wu, Doctor

    Landseed International Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 28, 2022

First Posted

August 2, 2022

Study Start

June 15, 2021

Primary Completion

July 1, 2021

Study Completion

June 8, 2022

Last Updated

August 2, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations