Chronic DiseaseNCT06550817
Growth Mindset Intervention for Older Adults With Chronic Disease
A study testing Growth mindset intervention and E-health Program in people with Chronic Disease, run by Huzhou University at 2 sites in China.
Trial summary
This study was conducted to develop and investigate the effectiveness of a growth mindset intervention based on growth mindset theory. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Growth mindset intervention and E-health Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2021to 31 Oct 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged≥60 years
- diagnosed≥1 chronic disease
- owned at least one smartphone
- could communicate clearly in writing or orally
- were willing to participate in this study
Who cannot join
- could not use WeChat or phone to communicate
- diagnosed as mental illness or cognitive impairment
- suffered from acute severe disease or lost self-care ability
- undergoing other similar training
Trial locations and contacts
2 sites in 1 country.
China2 sites
School of Medicine and Nursing， Huzhou University
Huzhou, Zhejiang, 313000
School of Nursing Huzhou University
Huzhou, Zhejiang, 313000
About this study
Official title: Growth Mindset Intervention Improves Positive Response to E-Health for Older Adults With Chronic Disease: A Randomized Controlled Trial
This study was conducted to develop and investigate the effectiveness of a growth mindset intervention based on growth mindset theory.
Read the detailed description
The study employed a quasi-randomized controlled trial design conducted over 12 weeks. Before conducting the study, the researchers numbered the wards of internal medicine departments (excluding intensive care units) according to the order of bed number. The wards were then randomly divided into intervention wards and control wards using a random number generator. Patients were recruited to the control group (e-health only) in the control ward and the intervention group (growth mindset intervention+ e-health) in the intervention unit. Participants in the control group could undergo the training after the study concluded.
- Conditions
- Chronic Disease
- Being tested
- Growth mindset intervention, E-health Program
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth mindset interventionOther
Online intervention is implemented and it lasts about 20 minutes each time, while face-to-face intervention lasts about 30 minutes each time, and they are carried out for a total of six weeks, face-to-face or telephone intervention is implemented once every two weeks for about 15 minutes each time
E-health ProgramOther
face-to-face e-health teaching in the first 6 weeks, and telephone follow-up were conducted once a week, for about 10 minutes each time in the last 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| growth mindset + e-health | Experimental | Participants received an e-health program intervention plus a growth mindset intervention over 12 weeks, with weekly sessions for the first 6 weeks and biweekly follow-up phone calls for the next six weeks. Receives: Other: Growth mindset intervention |
| e-health only | Active comparator | Participants received an e-health program intervention over 12 weeks, with weekly sessions for the first 6 weeks and biweekly follow-up phone calls for the next six weeks. Receives: Other: E-health Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implicit Theories of Intelligence Scale-6
The Implicit Theories of Intelligence Scale-6 (ITIS-6) is a validated, self-reported instrument assessing participants' level of growth mindset. A mean score of greater than or equal to 4 on all items indicates that the individual has a growth mindset, and vice versa for a fixed mindset.
Measured: Baseline,Week 6, and Week 12
Questionnaire of Knowledge, Willingness, Confidence, and Practice of Smart Medicine (KWCP-SM)
The Questionnaire of Knowledge, Willingness, Confidence, and Practice of Smart Medicine (KWCP-SM) is a validated, self-reported instrument assessing participants' level of knowledge, willingness, confidence, and practice of smart medicine. The questionnaire adopted the Likert-5 scoring method. The higher score indicated a higher level of knowledge, willingness, confidence, and practice of smart medicine.
Measured: Baseline,Week 6, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Sep 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaling Zeng, Huzhou University
- Investigators
- Meijuan Cao, Study chair, Huzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550817
- Sponsor's protocol ID
- 2022015
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Mindset Intervention Improves Positive Response to E-Health for Older Adults With Chronic Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06550817
- Acronym / sponsor ID
- 2022015
- Conditions
- Chronic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Huzhou UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 13 Aug 2024 (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 was conducted to develop and investigate the effectiveness of a growth mindset intervention based on growth mindset theory.
Detailed description
The study employed a quasi-randomized controlled trial design conducted over 12 weeks. Before conducting the study, the researchers numbered the wards of internal medicine departments (excluding intensive care units) according to the order of bed number. The wards were then randomly divided into intervention wards and control wards using a random number generator. Patients were recruited to the control group (e-health only) in the control ward and the intervention group (growth mindset intervention+ e-health) in the intervention unit. Participants in the control group could undergo the training after the study concluded.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| growth mindset + e-health | Experimental | Other: Growth mindset interventionParticipants received an e-health program intervention plus a growth mindset intervention over 12 weeks, with weekly sessions for the first 6 weeks and biweekly follow-up phone calls for the next six weeks. |
| e-health only | Active comparator | Other: E-health ProgramParticipants received an e-health program intervention over 12 weeks, with weekly sessions for the first 6 weeks and biweekly follow-up phone calls for the next six weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged≥60 years
- diagnosed≥1 chronic disease
- owned at least one smartphone
- could communicate clearly in writing or orally
- were willing to participate in this study
Key exclusion criteria (4 listed)
- could not use WeChat or phone to communicate
- diagnosed as mental illness or cognitive impairment
- suffered from acute severe disease or lost self-care ability
- undergoing other similar training
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 |
|---|---|---|
| Growth mindset interventionOnline intervention is implemented and it lasts about 20 minutes each time, while face-to-face intervention lasts about 30 minutes each time, and they are carried out for a total of six weeks, face-to-face or telephone intervention is implemented once every two weeks for about 15 minutes each time | Other | growth mindset + e-health |
| E-health Programface-to-face e-health teaching in the first 6 weeks, and telephone follow-up were conducted once a week, for about 10 minutes each time in the last 6 weeks | Other | e-health only |
Primary outcome
Implicit Theories of Intelligence Scale-6
Time frame: Baseline,Week 6, and Week 12
The Implicit Theories of Intelligence Scale-6 (ITIS-6) is a validated, self-reported instrument assessing participants' level of growth mindset. A mean score of greater than or equal to 4 on all items indicates that the individual has a growth mindset, and vice versa for a fixed mindset.
Questionnaire of Knowledge, Willingness, Confidence, and Practice of Smart Medicine (KWCP-SM)
Time frame: Baseline,Week 6, and Week 12
The Questionnaire of Knowledge, Willingness, Confidence, and Practice of Smart Medicine (KWCP-SM) is a validated, self-reported instrument assessing participants' level of knowledge, willingness, confidence, and practice of smart medicine. The questionnaire adopted the Likert-5 scoring method. The higher score indicated a higher level of knowledge, willingness, confidence, and practice of smart medicine.
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 13 Aug 2024.
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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.
Meijuan Cao study chair
Huzhou University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Growth mindset intervention and E-health Program in people with Chronic Disease, run by Huzhou University at 2 sites in China.
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 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Implicit Theories of Intelligence Scale-6 (time frame: Baseline,Week 6, and Week 12). The study lists 2 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 13 Aug 2024.