TelemedicineNCT05483478
Effectiveness of Mobile Health on Frailty, Muscle Strength and Health Literacy of the Elderly
A study testing mobile health combined Multi-course Program in people with Telemedicine and Elderly, run by Landseed Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 65 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Telemedicine, Elderly, Health Literacy
- What is being tested?
- mobile health combined Multi-course Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jun 2021to 8 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 84 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Combined Mobile Health and Multicomponent Program Intervention on Frailty, Muscle Strength and Health Literacy of the Elderly in the Community
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.
Read the 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.
- Conditions
- Telemedicine, Elderly, Health Literacy
- Being tested
- mobile health combined Multi-course Program
- Keywords
- mobile health, frailty, health literacy, muscle strength
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile health combined Multi-course ProgramCombination product
mobile health combined Multi-course Program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: mobile health combined Multi-course Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, during the procedure, through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start15 Jun 2021
- Primary completion1 Jul 2021
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landseed Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-Hua Chien, Landseed Hospital
- Investigators
- Qing-Ping Wu, Doctor, Study chair, Landseed International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483478
- Sponsor's protocol ID
- 21-018-A2
- Status last verified
- Aug 2022
- First submitted
- 28 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Combined Mobile Health and Multicomponent Program Intervention on Frailty, Muscle Strength and Health Literacy of the Elderly in the Community
- ClinicalTrials.gov ID
- NCT05483478
- Acronym / sponsor ID
- 21-018-A2
- Conditions
- Telemedicine, Elderly, Health Literacy
- Keywords
- mobile health, frailty, health literacy, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Landseed HospitalUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mobile health combined Multi-course Program | Experimental | Combination Product: mobile health combined Multi-course ProgramThe 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. |
| Multi-course Program | Active comparator | Combination Product: mobile health combined Multi-course ProgramThe 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. |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile health combined Multi-course Programmobile health combined Multi-course Program | Combination product | Multi-course Program, mobile health combined Multi-course Program |
Primary outcome
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.
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.
Health Literacy
Time frame: baseline, during the procedure, through study completion
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
Time frame: baseline, during the procedure, through study completion
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing-Ping Wu, Doctor study chair
Landseed International Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile health combined Multi-course Program in people with Telemedicine and Elderly, run by Landseed Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frailty assessment (time frame: baseline, during the procedure, through study completion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.