Multiple Chronic Conditions；Diabetes；HypertensionNCT06313138
Effectiveness of Health Literacy Enhancement Program Among Older Persons With Physical Multimorbidity
A study testing The Individual and Family Enhancement Program in people with Multiple Chronic Conditions；Diabetes；Hypertension, run by Nantong University at 1 site in China.
Trial summary
The study aims to examine the effectiveness of individual and family health literacy enhancement program among older persons with physical multimorbidity. Specific objectives are: 1. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Multiple Chronic Conditions；Diabetes；Hypertension
- What is being tested?
- The Individual and Family Enhancement Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2023to 30 Jan 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60-80 years old;
- Having been diagnosed with hypertension and type 2 diabetes for at least 6 months;
- Being able to read and write Chinese language;
- Cognitive intact as measured by the Mini-Mental State Examination (MMSE) with the score ≥ 24;
- Physically independence as measured by the Barthel ADL Index and the score above 12 out of 20 ;
- Willing to participate in the study;
- Having at least a family member who is willing to participate in the study.
Who cannot join
- Having other diseases or severe complications from their health problems that making them unable to fully participate through all process of the program including ischemic heart disease, myocardial infarction, heart failure, stroke, acute renal failure, diabetic ketoacidosis, and diabetic coma;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Individual and Family Health Literacy Enhancement Program Among Older Persons With Physical Multimorbidity
The study aims to examine the effectiveness of individual and family health literacy enhancement program among older persons with physical multimorbidity.
Specific objectives are:
Read more
- To compare self-management, treatment burden, and symptom burden of older persons with physical multimorbidity between before and after receiving the individual and family health literacy enhancement program.
- To compare self-management, treatment burden, and symptom burden of older persons with physical multimorbidity between those receiving the individual and family health literacy enhancement program and those receiving usual care.
Participants in the control group will receive usual care by physician and nurses during the experimental period. The usual care consists of physical examination, regular treatment protocol, patient education and telephone follow-up by community nurses.
Participants in the interventional group will receive the program which is a group-based intervention developed by the researcher based on the Individual and Family Self-Management Theory (IFSMT) (self-management skills) and the principle of Medagogy (PITS model: Pathophysiology, Indications, Treatments, Specifies) to improve patients' and their families' understanding of disease-related information and self-management skills consisting of goal setting and action plan, self-monitoring, solving problems and decision-making, and emotional control.The program will be divided into 8 sessions. Each session will be lasted for 2 hours with 1 intermittent break (10 minutes), and it will be held twice a week, and the last session will be held 1 week after the 7th session. Therefore, it will last for 5 weeks in total.
- Being tested
- The Individual and Family Enhancement Program
- Keywords
- Aged; multimorbidity; Health literacy; Self-management.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Individual and Family Enhancement ProgramOther
The program is a group-based intervention which will be developed by the researcher based on the Individual and Family Self-Management Theory (IFSMT) (self-management skills) and the principle of Medagogy (PITS model: Pathophysiology, Indications, Treatments, Specifies) to improve patients' and their families' understanding of disease-related information and self-management skills consisting of goal setting and action plan, self-monitoring, solving problems and decision-making, and emotional control.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | The Individual and Family Enhancement Program Session 1(1st week): Assessment and exchange information and building trusting relationship between researcher and participants; Session 2-3(1st-2nd week): Information sharing based on PITS model (Pathophysiology, Symptoms, or signs) and evaluation participants' understanding based on UPP scale.
Session 4-5(2nd-3rd week): Information sharing based on PITS model (treatment) and health maintenance skills.
Session 6 (3rd week): Information sharing based on PITS model (specifics) and family role in self-management.
Session7(4th week): Evaluation and summary. Session 8(5th week): Assess health literacy and information provision Receives: Other: The Individual and Family Enhancement Program |
| control group | Other | Community nurses provide usual care Receives: Other: The Individual and Family Enhancement Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-management
Self-management will be measured by Partners in Health (PIH) Scale for older persons with physical multimorbidity which was originally developed by Battersby et al in 2003 and translated into Chinese by Chiu in 2017. The possible total score was between 0 and 96. A higher total score indicates patients with better self-management knowledge and behaviors.
Measured: 8 weeks after intervention completion
Treatment burden
Treatment burden will be measured by the Treatment Burden Questionnaire (TBQ) initially developed and validated in the France by Tran (2012) and translated into Chinese by Zhang (2021). Each item is scored from 0(not problem) to 10 (big problem) with total scores ranging from 0 (no burden) to 150(high burden). A higher score indicates higher treatment burden.
Measured: 12 weeks after intervention completion
Symptom burden
Symptom burden will be measured by The Memorial Symptom Assessment Scale Short Form MSAS(MSAS-SF) initially developed by Chang et al (2000) and translated into simplified Chinese language by Fu et al (2018). The total score is the average severity of symptoms within past week, with symptoms not experienced scored as a zero. A higher score equates to greater symptom burden.
Measured: 12 weeks after intervention completion
Secondary outcomes (1)
Health literacy
Health literacy will be measured by the functional Communication Critical Health Literacy (FCCHL) for older persons with physical multimorbidity which was originally developed by Ishikawa et al (2008) and translated into Chinese by Zhao XY(2021). The total health literacy scale wasformed by adding all fourteen items. Each item is rated on a 4-point Likert scale, ranging from 1 (never) to 4 (often), with a higher score reflecting abundant health literacy.
be used to monitor the intermediate outcome of the program implementation and will be measured by the functional Communication Critical Health Literacy (FCCHL)(Ishikawa, Takeuchi, \& Yano, 2008) for older persons with physical multimorbidity which was originally developed by Ishikawa et al (2008) and translated into Chinese by Zhao XY(2021)
Measured: 1 week after intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start15 Jul 2023
- Primary completion25 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Chronic Conditions；Diabetes；HypertensionStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantong University
- Sponsor type
- University, hospital or other
- Collaborators
- Chiang Mai University
- Responsible party
- Principal investigator, Jun Shan, Nantong University
- Investigators
- Jun Shan, Principal investigator, Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313138
- Sponsor's protocol ID
- NantongJS
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2024
- Last updated
- 15 Mar 2024
- 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Individual and Family Health Literacy Enhancement Program Among Older Persons With Physical Multimorbidity
- ClinicalTrials.gov ID
- NCT06313138
- Acronym / sponsor ID
- NantongJS
- Keywords
- Aged; multimorbidity; Health literacy; Self-management.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Nantong UniversityUniversity, hospital or other
- Collaborators
- Chiang Mai University
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 15 Mar 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.
The study aims to examine the effectiveness of individual and family health literacy enhancement program among older persons with physical multimorbidity.
Specific objectives are:
- To compare self-management, treatment burden, and symptom burden of older persons with physical multimorbidity between before and after receiving the individual and family health literacy enhancement program.
- To compare self-management, treatment burden, and symptom burden of older persons with physical multimorbidity between those receiving the individual and family health literacy enhancement program and those receiving usual care.
Participants in the control group will receive usual care by physician and nurses during the experimental period. The usual care consists of physical examination, regular treatment protocol, patient education and telephone follow-up by community nurses.
Participants in the interventional group will receive the program which is a group-based intervention developed by the researcher based on the Individual and Family Self-Management Theory (IFSMT) (self-management skills) and the principle of Medagogy (PITS model: Pathophysiology, Indications, Treatments, Specifies) to improve patients' and their families' understanding of disease-related information and self-management skills consisting of goal setting and action plan, self-monitoring, solving problems and decision-making, and emotional control.The program will be divided into 8 sessions. Each session will be lasted for 2 hours with 1 intermittent break (10 minutes), and it will be held twice a week, and the last session will be held 1 week after the 7th session. Therefore, it will last for 5 weeks in total.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: The Individual and Family Enhancement ProgramThe Individual and Family Enhancement Program Session 1(1st week): Assessment and exchange information and building trusting relationship between researcher and participants; Session 2-3(1st-2nd week): Information sharing based on PITS model (Pathophysiology, Symptoms, or signs) and evaluation participants' understanding based on UPP scale. Session 4-5(2nd-3rd week): Information sharing based on PITS model (treatment) and health maintenance skills. Session 6 (3rd week): Information sharing based on PITS model (specifics) and family role in self-management. Session7(4th week): Evaluation and summary. Session 8(5th week): Assess health literacy and information provision |
| control group | Other | Other: The Individual and Family Enhancement ProgramCommunity nurses provide usual care |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 60-80 years old;
- Having been diagnosed with hypertension and type 2 diabetes for at least 6 months;
- Being able to read and write Chinese language;
- Cognitive intact as measured by the Mini-Mental State Examination (MMSE) with the score ≥ 24;
- Physically independence as measured by the Barthel ADL Index and the score above 12 out of 20 ;
Key exclusion criteria (1 listed)
- Having other diseases or severe complications from their health problems that making them unable to fully participate through all process of the program including ischemic heart disease, myocardial infarction, heart failure, stroke, acute renal failure, diabetic ketoacidosis, and diabetic coma;
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 |
|---|---|---|
| The Individual and Family Enhancement ProgramThe program is a group-based intervention which will be developed by the researcher based on the Individual and Family Self-Management Theory (IFSMT) (self-management skills) and the principle of Medagogy (PITS model: Pathophysiology, Indications, Treatments, Specifies) to improve patients' and their families' understanding of disease-related information and self-management skills consisting of goal setting and action plan, self-monitoring, solving problems and decision-making, and emotional control. | Other | Interventional group, control group |
Primary outcome
Self-management
Time frame: 8 weeks after intervention completion
Self-management will be measured by Partners in Health (PIH) Scale for older persons with physical multimorbidity which was originally developed by Battersby et al in 2003 and translated into Chinese by Chiu in 2017. The possible total score was between 0 and 96. A higher total score indicates patients with better self-management knowledge and behaviors.
Treatment burden
Time frame: 12 weeks after intervention completion
Treatment burden will be measured by the Treatment Burden Questionnaire (TBQ) initially developed and validated in the France by Tran (2012) and translated into Chinese by Zhang (2021). Each item is scored from 0(not problem) to 10 (big problem) with total scores ranging from 0 (no burden) to 150(high burden). A higher score indicates higher treatment burden.
Symptom burden
Time frame: 12 weeks after intervention completion
Symptom burden will be measured by The Memorial Symptom Assessment Scale Short Form MSAS(MSAS-SF) initially developed by Chang et al (2000) and translated into simplified Chinese language by Fu et al (2018). The total score is the average severity of symptoms within past week, with symptoms not experienced scored as a zero. A higher score equates to greater symptom burden.
1 secondary outcome
Health literacy
Time frame: 1 week after intervention completion
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 15 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Multiple Chronic Conditions；Diabetes；Hypertension
Enrolling by invitation
ECHO for Diabetes and Multiple Chronic Conditions Study
Diabetes Mellitus, Chronic Disease
Recruiting
Digital Care for Holistic Health in Older Adults With Diabetes and Multimorbidity
Type2Diabetes, Hypertension
Active, not recruiting
Evaluation of Nurse-led Integrated Care of Complex Patients Facilitated By Telemonitoring: The SMaRT Study
Heart Failure，Congestive, Mental Health (Depression)
RecruitingObservational study
Assessment and Management of Multiple Drug Use in Elderly Chronic Disease Patients
Coronary Artery Disease, Diabete Mellitus
RecruitingObservational study
EMPOWER-1: A Multi-site Clinical Cohort Research Study to Reduce Health Inequality
Atrial Fibrillation, Coronary Heart Disease
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.
Jun Shan principal investigator
Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Individual and Family Enhancement Program in people with Multiple Chronic Conditions；Diabetes；Hypertension, run by Nantong University at 1 site 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 7 inclusion and 1 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 15 Mar 2024. 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 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?
Self-management (time frame: 8 weeks after intervention completion). The study lists 3 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 15 Mar 2024.