HypertensionNCT06998511
Interdisciplinary Collaborative Care Model Combined With Family Empowerment in Comorbid Hypertension and Diabetes
A study testing interdisciplinary collaborative care and family empowerment (ICCM-FE) intervention and routine nursing intervention in people with Hypertension and Diabetes, run by Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science at 1 site in China.
Trial summary
The Iinterdisciplinary collaborative care model combined with family empowerment (ICCM-FE) intervention based on the COM-B model can effectively improve blood pressure and glucose control in patients with comorbid hypertension and diabetes, enhance their quality of life and psychosocial adaptation, and significantly… Read more about this study
- Who is it for?
- Ages 36 to 58 years
- Conditions the study is for
- Hypertension, Diabetes, Blood Pressure Control
- What is being tested?
- interdisciplinary collaborative care and family empowerment (ICCM-FE) intervention and routine nursing intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2023to 16 Mar 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 36 to 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients met the diagnostic criteria for hypertension and diabetes as specified in the 《2020 International Society of Hypertension Global Hypertension Practice Guidelines》and the 《2020 American Diabetes Association (ADA) Standards of Medical Care in Diabetes》 ;
- had at least one caregiver, and both the patient and caregiver had basic communication and comprehension abilities to cooperate with the nursing interventions and complete the questionnaires;
- voluntarily participated in the study and signed an informed consent form;
- complete follow-up records.
Who cannot join
- severe organ dysfunction or mental illness;
- malignancies, severe cardiovascular events (e.g., stroke, myocardial infarction);
- severe hepatic or renal impairment;
- poor adherence or life expectancy less than 1 year.
Trial locations and contacts
1 site in 1 country.
China1 site
Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science
Xiangyang, 441138
About this study
Official title: Interdisciplinary Collaborative Care Model Combined With Family Empowerment in Patients With Comorbid Hypertension and Diabetes
The Iinterdisciplinary collaborative care model combined with family empowerment (ICCM-FE) intervention based on the COM-B model can effectively improve blood pressure and glucose control in patients with comorbid hypertension and diabetes, enhance their quality of life and psychosocial adaptation, and significantly increase patient satisfaction with nursing care. This intervention has important clinical application value.
Read the detailed description
To evaluate the efficacy of an interdisciplinary collaborative care model combined with family empowerment (ICCM-FE) based on the COM-B model in managing comorbid hypertension and diabetes, focusing on its impact on blood pressure, glucose control, and psychosocial adaptation. This prospective randomized controlled trial (RCT) enrolled 187 patients with comorbid hypertension and diabetes from January 2023 to March 2024. Patients were randomly assigned to a control group (n = 93) receiving routine care and an observation group (n = 94) receiving ICCM-FE intervention. Follow-up was conducted over 6 months, assessing blood pressure (SBP and DBP), glucose levels (FPG and HbA1c), quality of life (SF-36 scale), psychosocial adaptation (PAIS-SR scale), and nursing satisfaction (NSNS scale) pre- and post-intervention.
- Being tested
- interdisciplinary collaborative care and family empowerment (ICCM-FE) intervention, routine nursing intervention
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interdisciplinary collaborative care and family empowerment (ICCM-FE) interventionOther
The observation group received interdisciplinary collaborative care and family empowerment (ICCM-FE) intervention based on the COM-B model on the basis of routine care.
routine nursing interventionOther
The control group received routine nursing intervention, including basic drug treatment, diet and exercise guidance, psychological counseling, etc.
| Study group | Role | What they receive |
|---|---|---|
| routine nursing intervention | Other | The control group received routine nursing intervention, including basic drug treatment, diet and exercise guidance, psychological counseling, etc. Receives: Other: routine nursing intervention |
| interdisciplinary collaborative care and family empowerment (ICCM-FE) intervention | Other | The observation group received interdisciplinary collaborative care and family empowerment (ICCM-FE) intervention based on the COM-B model on the basis of routine care. Receives: Other: interdisciplinary collaborative care and family empowerment (ICCM-FE) intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Control
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to 6 months post-intervention.
Measured: Baseline and 6 months.
Secondary outcomes (4)
Quality of Life (SF-36 Scale)
Change in SF-36 scores across eight domains (physical function, mental health, role limitations, etc.) from baseline to 6 months post-intervention.
Measured: Baseline and 6 months
Psychosocial Adaptation (PAIS-SR Scale)
Change in psychosocial adjustment scores (healthcare orientation, occupational/family environment, psychological stress, etc.) from baseline to 6 months post-intervention.
Measured: Baseline and 6 months.
Self-Efficacy (GSES Scale)
Change in General Self-Efficacy Scale (GSES) scores from baseline to 6 months post-intervention.
Measured: Baseline and 6 months.
Nursing Satisfaction (NSNS Scale)
Patient satisfaction with nursing care measured using the Newcastle Satisfaction with Nursing Services Scale (NSNS) at 6 months post-intervention.
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start7 Jan 2023
- Primary completion5 Sep 2023
- Study completion16 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Qiqi Wu, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998511
- Sponsor's protocol ID
- No. 2025-068
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 31 May 2025
- 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 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdisciplinary Collaborative Care Model Combined With Family Empowerment in Patients With Comorbid Hypertension and Diabetes
- ClinicalTrials.gov ID
- NCT06998511
- Acronym / sponsor ID
- No. 2025-068
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and ScienceOther government
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 16 Mar 2024 (actual)
- First posted
- 31 May 2025 (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 Iinterdisciplinary collaborative care model combined with family empowerment (ICCM-FE) intervention based on the COM-B model can effectively improve blood pressure and glucose control in patients with comorbid hypertension and diabetes, enhance their quality of life and psychosocial adaptation, and significantly increase patient satisfaction with nursing care. This intervention has important clinical application value.
Detailed description
To evaluate the efficacy of an interdisciplinary collaborative care model combined with family empowerment (ICCM-FE) based on the COM-B model in managing comorbid hypertension and diabetes, focusing on its impact on blood pressure, glucose control, and psychosocial adaptation. This prospective randomized controlled trial (RCT) enrolled 187 patients with comorbid hypertension and diabetes from January 2023 to March 2024. Patients were randomly assigned to a control group (n = 93) receiving routine care and an observation group (n = 94) receiving ICCM-FE intervention. Follow-up was conducted over 6 months, assessing blood pressure (SBP and DBP), glucose levels (FPG and HbA1c), quality of life (SF-36 scale), psychosocial adaptation (PAIS-SR scale), and nursing satisfaction (NSNS scale) pre- and post-intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine nursing intervention | Other | Other: routine nursing interventionThe control group received routine nursing intervention, including basic drug treatment, diet and exercise guidance, psychological counseling, etc. |
| interdisciplinary collaborative care and family empowerment (ICCM-FE) intervention | Other | Other: interdisciplinary collaborative care and family empowerment (ICCM-FE) interventionThe observation group received interdisciplinary collaborative care and family empowerment (ICCM-FE) intervention based on the COM-B model on the basis of routine care. |
Who may qualify
- Ages
- 36 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients met the diagnostic criteria for hypertension and diabetes as specified in the 《2020 International Society of Hypertension Global Hypertension Practice Guidelines》and the 《2020 American Diabetes Association (ADA) Standards of Medical Care in Diabetes》 ;
- had at least one caregiver, and both the patient and caregiver had basic communication and comprehension abilities to cooperate with the nursing interventions and complete the questionnaires;
- voluntarily participated in the study and signed an informed consent form;
- complete follow-up records.
Key exclusion criteria (4 listed)
- severe organ dysfunction or mental illness;
- malignancies, severe cardiovascular events (e.g., stroke, myocardial infarction);
- severe hepatic or renal impairment;
- poor adherence or life expectancy less than 1 year.
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 |
|---|---|---|
| interdisciplinary collaborative care and family empowerment (ICCM-FE) interventionThe observation group received interdisciplinary collaborative care and family empowerment (ICCM-FE) intervention based on the COM-B model on the basis of routine care. | Other | interdisciplinary collaborative care and family empowerment (ICCM-FE) intervention |
| routine nursing interventionThe control group received routine nursing intervention, including basic drug treatment, diet and exercise guidance, psychological counseling, etc. | Other | routine nursing intervention |
Primary outcome
Blood Pressure Control
Time frame: Baseline and 6 months.
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to 6 months post-intervention.
4 secondary outcomes
Quality of Life (SF-36 Scale)
Time frame: Baseline and 6 months
Psychosocial Adaptation (PAIS-SR Scale)
Time frame: Baseline and 6 months.
Self-Efficacy (GSES Scale)
Time frame: Baseline and 6 months.
Nursing Satisfaction (NSNS Scale)
Time frame: 6 months.
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 31 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interdisciplinary collaborative care and family empowerment (ICCM-FE) intervention and routine nursing intervention in people with Hypertension and Diabetes, run by Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science 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 4 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 31 May 2025. 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?
Blood Pressure Control (time frame: Baseline and 6 months.). 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 31 May 2025.