- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06550817
Growth Mindset Intervention for Older Adults With Chronic Disease
August 12, 2024 updated by: Yaling Zeng, Huzhou University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
77
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Zhejiang
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Huzhou, Zhejiang, China, 313000
- School of Medicine and Nursing, Huzhou University
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Huzhou, Zhejiang, China, 313000
- School of Nursing Huzhou University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: growth mindset + e-health
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.
|
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
|
|
Active Comparator: e-health only
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline,Week 6, and Week 12
|
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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.
|
Baseline,Week 6, and Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Meijuan Cao, Huzhou University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Actual)
October 31, 2022
Study Completion (Actual)
October 31, 2022
Study Registration Dates
First Submitted
August 6, 2024
First Submitted That Met QC Criteria
August 12, 2024
First Posted (Actual)
August 13, 2024
Study Record Updates
Last Update Posted (Actual)
August 13, 2024
Last Update Submitted That Met QC Criteria
August 12, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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