HypertensionNCT05353699
Implementation of a Comprehensive Intervention on Hypertension（HTN） and Type 2 Diabetes Mellitus（DM） at PHC Level
A study testing Implementation strategies in people with Hypertension and Diabetes Mellitus, Type 2, run by National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC at 1 site in China.
Trial summary
Background: The disease burden of hypertension(HTN) and type 2 diabetes mellitus(DM) is rising rapidly in China.Comprehensive interventions(Implementation strategies for providers and interventions for patients) are critical to strengthen primary health care systems and address the burden of multiple comorbidities. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Type 2
- What is being tested?
- Implementation strategies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,648 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 31 Jan 2023
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
For the quantitative questionnaire survey, the demander's population in phase 1 will include a total of 5464 patients with HTN and 7040 patients with type 2 DM in the 8 selected primary medical institutions.The demander's population in phase 2 is the same as that in phase 1.In phase 3, the demander's population will include a total of 2280 patients with HTN and 2656 patients with type 2 DM in the 8 selected primary medical institutions.
- Inclusion criteria for respondents:①Patients with HTN and type 2 DM who have received basic public health service management for more than one year, and have no plan to move within the next year; ②Have normal communication ability and independent behavior ability; ③Volunteer to participate in the project questionnaire survey and provide the informed consents.
- Exclusion criteria for respondents:①Patients with severe chronic diseases or in acute stage who cannot cooperate with investigators; ②Mental disorders or cognitive disorders (including dementia, cognitive impairment, deafness, etc.).
For the qualitative interview component, the provider's population will include policy-decision makers, managers, health professionals, healthcare workers who provide health management services for HTN and type 2 DM, and stakeholders who contain governmental officials/staff from civil society/non-governmental organization.Focus group discussions (FGDs) will be conducted. At each level, a group of people gets together for focus groups.During the interview, the specific number of interviewees shall be determined according to the principle of information saturation.
- Inclusion criteria for interviewees:①Health care personnel responsible for community HTN or type 2 DM management; ②Responsible for the national basic public health service project -HTN, type 2 DM health management work for at least 12 months; ③Willing to participate in the project; ④Willing to be interviewed;⑤Good presentation and verbal communication skills.
- Exclusion criteria for interviewees:①Health care workers who were not responsible for hypertensive or diabetic management;②Health care workers who carried out the management for less than 12 months;③Those who are not willing to participate in the project;④Unwilling to be interviewed;⑤Lack of expressive ability or difficulty in communicating in Mandarin; The demander's population will include a total of 80 patients with HTN and type 2 DM in the selected 8 primary medical institutions. The qualitative interview mainly adopts the personal in-depth interview method to understand the main problems in the implementation of the intervention measures, explore the causes of the problems, and possible improvement measures and suggestions.
- Inclusion criteria include:①patients who have participated in management;②patients who are active in conversation;③patients who are willing to participate in interviews.
- Exclusion criteria for patients:①patients with hypertension or diabetes who do not participate in the management;②patients who are not willing to be interviewed.
Trial locations and contacts
1 site in 1 country.
China1 site
National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention
Beijing, Beijing Municipality, 100050
About this study
Official title: Implementation of a Comprehensive Intervention on Hypertension（HTN） and Type 2 Diabetes Mellitus（DM） at PHC Level: a Hybrid Type II Cluster-controlled Multisite Effectiveness-implementation Trial
Background: The disease burden of hypertension(HTN) and type 2 diabetes mellitus(DM) is rising rapidly in China.Comprehensive interventions(Implementation strategies for providers and interventions for patients) are critical to strengthen primary health care systems and address the burden of multiple comorbidities. In order to promote equal access to health services and narrow the gap in population health, China has launched the national Essential Public Health Services Equity Programme (EPHSEP) nationwide. EPHSEP contains guidelines for health management services for HTN and type 2 DM. The program has been in operation for 10 years. However, the management of HTN and type 2 DM in China is far from satisfactory. The purpose of this study is to understand current control and management situation of HTN and type 2 DM, investigate the barriers and facilitators in the implementation of HTN and type 2 DM service delivery standards, propose feasible implementation strategies,implement in certain areas,and to evaluate the effectiveness of interventions and the performance and impact of implementation strategies.
Methods: Based on previous work,four community health service centres and four township health centres will be selected in West Coast District of Qingdao city of Shandong province,Suzhou City of Jiangsu province, Changsha city of Hunan province and Luohe city of Henan Province.In each of the four provinces,one community health service center and one township health center will be selected.Two community health service centres and two township health centres will be selected as the intervention groups, and the other community health service centres and township health centres will be selected as the control groups.
Read more
The study will be divided into three phases: Phase 1, 2 and 3. Phase 1 and phase 2 cross-sectional studies are the basis for phase 3 intervention studies.
Phase 1 will be conducted from March 2022 to April 2022.In phase 1, a quantitative questionnaire survey will be conducted among 5464 HTN and 7040 type 2 DM patients in 8 community health service centers to obtain the data of awareness rate, screening rate, diagnosis rate, treatment rate, control rate and management service of hypertension and type 2 diabetes patients,so as to understand current control and management situation of HTN and type 2 DM.
Phase 2 will be conducted in April 2022. In phase 2, about 64 medical staff and related managers providing HTN and type 2 DM health management services and 80 patients with HTN and type 2 DM in 8 community health service centers will be investigated through qualitative interviews,so as to investigate the barriers and facilitators in the implementation of HTN and type 2 DM service delivery standards and to propose feasible implementation strategies.
Phase 3 will be conducted a mixed-methods type 2 hybrid effectiveness-implementation study from May 2022 to January 2023. Interventions are divided into four levels through a cascading model of screening, diagnosis, treatment, and control. Implementation strategies are divided into 6 categories according to Implementation Mapping: Capacity-building strategies（Recruit, designate, and train for leadership; Work with educational institutions), Supervision(Provide clinical supervision), Integration strategies(Remind clinicians; Use data warehousing techniques), Implementation process Strategies(Identify and prepare champions; Identify early adopters; Inform local opinion leaders; Involve patients/consumers and family members; Obtain and use patients/consumers and family feedback), Dissemination strategies(Make training dynamic), Scale-up strategies(Use train-the-trainer strategies;Place innovation on fee for service lists/formularies). We will adopt between site design to select 4（2*2 ）community health service centers and 4（2*2）township health centers, among which 2 community health service centers and 2 township health centers will implement the strategy, while the other selected sites will not implement the strategy. The 2*2 community health service centers and 2*2 township health centers will be divided into group matching control and self pre- and post-control. In phase 3, 2280 patients with HTN and 2656 patients with type 2 DM will be surveyed by quantitative questionnaire, and about 64 medical staff and related managers providing HTN and type 2 DM health management services will be surveyed by qualitative interview. This is to implement improved implementation strategies and to assess the effectiveness of interventions and the performance and impact of implementation strategies.
- Conditions
- Hypertension, Diabetes Mellitus, Type 2
- Being tested
- Implementation strategies
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation strategiesOther
We will adopt implementation strategies,which include Capacity-building strategies, Supervision, Integration strategies, Implementation process strategies, Dissemination strategies, Scale-up strategies.Firstly,Capacity-building strategies include:recruit, designate, and train for leadership; work with educational institutions.Secondly,Supervision includes provide clinical supervision;Thirdly,Integration strategies include: remind clinicians; use data warehousing techniques.Fourthly,Implementation process strategies include: identify and prepare champions; identify early adopters; inform local opinion leaders; involve patients/consumers and family members; obtain and use patients/consumers and family feedback.Fifthly,Dissemination strategies include: make training dynamic.Finally,Scale-up strategies include: use train-the-trainer strategies;place innovation on fee for service lists/formularies.
| Study group | Role | What they receive |
|---|---|---|
| Intervention groups | Experimental | Not described Receives: Other: Implementation strategies |
| Control groups | No intervention | as same as before |
What is being measured
The primary outcome is the main question the study is designed to answer.
Awareness change：Change from Baseline Awareness at 3, 6,9 months
Awareness of HTN/ type 2 DM in population:% awareness towards HTN/ type 2 DM in population.Survey method will be used to assess this outcome measure.
Measured: during the intervention; immediately after the intervention
Screening rate change：Change from Baseline Screening rate at 3, 6,9 months
Screening rate of patients with HTN/ type 2 DM:% patients with HTN/ type 2 DM screened among those who have ever screened blood pressure/blood sugar.Data will be obtained from administrative record.
Measured: during the intervention; immediately after the intervention
Diagnostic rate change：Change from Baseline Diagnostic rate at 3, 6,9 months
Diagnostic rate of patients with HTN/ type 2 DM:% patients with HTN/ type 2 DM diagnosed among those who have been screened blood pressure/blood sugar.Data will be obtained from administrative record.
Measured: during the intervention; immediately after the intervention
Treatment rate change：Change from Baseline Treatment rate at 3, 6,9 months
Treatment rate of patients with HTN:% patients with HTN who took antihypertensive drugs in the last two weeks was determined among those who have been diagnosed blood pressure; Treatment rate of patients with type 2 DM:% patients with type 2 DM who have taken treatment measures (including lifestyle intervention and/or medication) among those who have been diagnosed blood sugar.Data will be obtained from administrative record.
Measured: during the intervention; immediately after the intervention
Control rate change：Change from Baseline Control rate at 3, 6,9 months
Control rate of patients with HTN/type 2 DM:% patients whose blood pressure/ blood sugar are controlled among those who have been treated.Data will be obtained from administrative record.
Measured: during the intervention; immediately after the intervention
Implementation strategies use change: Change from Baseline Implementation at 3, 6,9 months
Implementation strategies use:qualitative interviews with managers of health centers.Interviews method will be used to assess this outcome measure.
Measured: during the intervention; immediately after the intervention
Supervision change: Change from Baseline Implementation at 3, 6,9 months
Supervision model: % scheduled supervision field visits completed.Data will be obtained from administrative data.
Measured: during the intervention; immediately after the intervention
Referral completeness change: Change from Baseline Implementation at 3, 6,9 months
Referral completeness: % referrals completed as prescribed by the clinical algorithm.Data will be obtained from administrative data.
Measured: during the intervention; immediately after the intervention
Adaptations to protocol change: Change from Baseline Implementation at 3, 6,9 months
Adaptations to protocol during intervention period: qualitative interviews with managers of local health department and health centers.Interviews method will be used to assess this outcome measure.
Measured: during the intervention; immediately after the intervention
Implementation change: Change from Baseline Implementation at 3, 6,9 months
Qualitative assessment: qualitative interviews with managers of health.Interviews method will be used to assess this outcome measure.
Measured: during the intervention; immediately after the intervention
Secondary outcomes (21)
Coverage change: Change from Baseline Reach at 3, 6,9 months
Coverage of population receiving health service for HTN and type 2 DM:proportion of target population receiving HTN and DM service.Data will be obtained from administrative data.
Measured: during the intervention; immediately after the intervention
Screening coverage of eligible for HTN change: Change from Baseline Reach at 3, 6,9 months
Screening coverage of eligible for HTN:proportion of eligible for HTN receiving screening.Data will be obtained from administrative data.
Measured: during the intervention; immediately after the intervention
Screening coverage of eligible for type 2 DM change: Change from Baseline Reach at 3, 6,9 months
Screening coverage of eligible for type 2 DM:proportion of eligible for type 2 DM receiving screening.Data will be obtained from administrative data.
Measured: during the intervention; immediately after the intervention
Coverage of screening for patients with HTN/type 2 DM change: Change from Baseline Reach at 3, 6,9 months
Coverage of screening for patients with HTN/type 2 DM:% patients with HTN/type 2 DM who have been screened for hypertension/ diabetes.Data will be obtained from administrative data.
Measured: during the intervention; immediately after the intervention
Readiness change: Change from Baseline Adoption at 3, 6,9 months
Readiness for implementation:a checklist to check readiness for implementation using.Data will be obtained from administrative data.
Measured: during the intervention; immediately after the intervention
Health centers/clinic's adoption change: Change from Baseline Adoption at 3, 6,9 months
Health centers/clinic's adoption: % proportion of health centers/clinics implemented lifestyle intervention and/or medication.Data will be obtained from administrative data.
Measured: during the intervention; immediately after the intervention
PHC professional's adoption change: Change from Baseline Adoption at 3, 6, 9 months
PHC professional's adoption:% of PHC professionals trained in implementing the guidelines for HTN and DM.Data will be obtained from administrative data.
Measured: during the intervention; immediately after the intervention
Timely adoption
Timely adoption：# early adopters at the local site. Observation methods will be used to assess this outcome measure.
Measured: during the intervention
Leader adoption change: Change from Baseline Adoption at 3, 6,9 months
Leader adoption: # leaders recruited/designated/trained for the change effort in intervention implementation.Interview and observation methods will be used to assess this outcome measure.
Measured: during the intervention; immediately after the intervention
Institution adoption change: Change from Baseline Adoption at 3, 6,9 months
Institution adoption:% intended Institution incorporated Administrative of HTN and DM in their routine service systems.Interview and observation methods will be used to assess this outcome measure.
Measured: during the intervention; immediately after the intervention
Follow-up fidelity change: Change from Baseline Fidelity at at 3, 6,9 months
Follow-up fidelity: % patients with "adequate" number of follow-up visits received.Data will be obtained from administrative data(records).
Measured: during the intervention; immediately after the intervention
Health professionals implemented guidelines/protocol change: Change from Baseline Fidelity at at 3, 6,9 months
Health professionals implemented guidelines /protocol: % of PHC professionals implemented according to the guidelines/protocol in actual work. Interview and observation methods will be used to assess this outcome measure.
Measured: during the intervention; immediately after the intervention
Qualitative assessment-Behavior changes sustained (staff)
Long-term maintenance of changes in management behavior related to hypertension/type 2 DM. Interview and observation methods will be used to assess this outcome measure.
Measured: 15 months
HTN and type 2 DM institutionalized
HTN and type 2 DM become institutionalized or part of the routine organizational practices.Data will be obtained from administrative data and survey.
Measured: immediately after the intervention
Settings continue the intervention
proportion and representativeness of settings that continue the intervention.Data will be obtained from administrative data.
Measured: immediately after the intervention
Total intervention cost
Total intervention cost per patient.Data will be obtained from administrative data.
Measured: immediately after the intervention
Total treatment cost
Total treatment cost per patient.Data will be obtained from administrative data.
Measured: immediately after the intervention
Intervention maintenance costs
% breakdown of maintenance (recurring) costs (ongoing training, personnel, materials, and other).Data will be obtained from administrative data.
Measured: immediately after the intervention
Facility vs. community costs
% of costs of healthcare divided between facility level and community level.Data will be obtained from administrative data.
Measured: immediately after the intervention
out-of-pocket patient costs
% out-of-pocket patient costs.Survey method will be used to assess this outcome measure.
Measured: immediately after the intervention
Qualitative assessment-maintenance:
Interviews method will be used to assess this outcome measure.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12,648 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353699
- Sponsor's protocol ID
- Shiqihu
- Status last verified
- Apr 2022
- First submitted
- 28 Feb 2022
- Last updated
- 29 Apr 2022
- 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 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Comprehensive Intervention on Hypertension（HTN） and Type 2 Diabetes Mellitus（DM） at PHC Level: a Hybrid Type II Cluster-controlled Multisite Effectiveness-implementation Trial
- ClinicalTrials.gov ID
- NCT05353699
- Acronym / sponsor ID
- Shiqihu
- Conditions
- Hypertension, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12,648 participants (estimated)
- Lead sponsor
- National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDCUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 29 Apr 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.
Background: The disease burden of hypertension(HTN) and type 2 diabetes mellitus(DM) is rising rapidly in China.Comprehensive interventions(Implementation strategies for providers and interventions for patients) are critical to strengthen primary health care systems and address the burden of multiple comorbidities. In order to promote equal access to health services and narrow the gap in population health, China has launched the national Essential Public Health Services Equity Programme (EPHSEP) nationwide. EPHSEP contains guidelines for health management services for HTN and type 2 DM. The program has been in operation for 10 years. However, the management of HTN and type 2 DM in China is far from satisfactory. The purpose of this study is to understand current control and management situation of HTN and type 2 DM, investigate the barriers and facilitators in the implementation of HTN and type 2 DM service delivery standards, propose feasible implementation strategies,implement in certain areas,and to evaluate the effectiveness of interventions and the performance and impact of implementation strategies.
Methods: Based on previous work,four community health service centres and four township health centres will be selected in West Coast District of Qingdao city of Shandong province,Suzhou City of Jiangsu province, Changsha city of Hunan province and Luohe city of Henan Province.In each of the four provinces,one community health service center and one township health center will be selected.Two community health service centres and two township health centres will be selected as the intervention groups, and the other community health service centres and township health centres will be selected as the control groups.
The study will be divided into three phases: Phase 1, 2 and 3. Phase 1 and phase 2 cross-sectional studies are the basis for phase 3 intervention studies.
Phase 1 will be conducted from March 2022 to April 2022.In phase 1, a quantitative questionnaire survey will be conducted among 5464 HTN and 7040 type 2 DM patients in 8 community health service centers to obtain the data of awareness rate, screening rate, diagnosis rate, treatment rate, control rate and management service of hypertension and type 2 diabetes patients,so as to understand current control and management situation of HTN and type 2 DM.
Phase 2 will be conducted in April 2022. In phase 2, about 64 medical staff and related managers providing HTN and type 2 DM health management services and 80 patients with HTN and type 2 DM in 8 community health service centers will be investigated through qualitative interviews,so as to investigate the barriers and facilitators in the implementation of HTN and type 2 DM service delivery standards and to propose feasible implementation strategies.
Phase 3 will be conducted a mixed-methods type 2 hybrid effectiveness-implementation study from May 2022 to January 2023. Interventions are divided into four levels through a cascading model of screening, diagnosis, treatment, and control. Implementation strategies are divided into 6 categories according to Implementation Mapping: Capacity-building strategies（Recruit, designate, and train for leadership; Work with educational institutions), Supervision(Provide clinical supervision), Integration strategies(Remind clinicians; Use data warehousing techniques), Implementation process Strategies(Identify and prepare champions; Identify early adopters; Inform local opinion leaders; Involve patients/consumers and family members; Obtain and use patients/consumers and family feedback), Dissemination strategies(Make training dynamic), Scale-up strategies(Use train-the-trainer strategies;Place innovation on fee for service lists/formularies). We will adopt between site design to select 4（2*2 ）community health service centers and 4（2*2）township health centers, among which 2 community health service centers and 2 township health centers will implement the strategy, while the other selected sites will not implement the strategy. The 2*2 community health service centers and 2*2 township health centers will be divided into group matching control and self pre- and post-control. In phase 3, 2280 patients with HTN and 2656 patients with type 2 DM will be surveyed by quantitative questionnaire, and about 64 medical staff and related managers providing HTN and type 2 DM health management services will be surveyed by qualitative interview. This is to implement improved implementation strategies and to assess the effectiveness of interventions and the performance and impact of implementation strategies.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention groups | Experimental | Other: Implementation strategies |
| Control groups | No intervention | –as same as before |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Implementation strategiesWe will adopt implementation strategies,which include Capacity-building strategies, Supervision, Integration strategies, Implementation process strategies, Dissemination strategies, Scale-up strategies.Firstly,Capacity-building strategies include:recruit, designate, and train for leadership; work with educational institutions.Secondly,Supervision includes provide clinical supervision;Thirdly,Integration strategies include: remind clinicians; use data warehousing techniques.Fourthly,Implementation process strategies include: identify and prepare champions; identify early adopters; inform local opinion leaders; involve patients/consumers and family members; obtain and use patients/consumers and family feedback.Fifthly,Dissemination strategies include: make training dynamic.Finally,Scale-up strategies include: use train-the-trainer strategies;place innovation on fee for service lists/formularies. | Other | Intervention groups |
Primary outcome
Awareness change：Change from Baseline Awareness at 3, 6,9 months
Time frame: during the intervention; immediately after the intervention
Awareness of HTN/ type 2 DM in population:% awareness towards HTN/ type 2 DM in population.Survey method will be used to assess this outcome measure.
Screening rate change：Change from Baseline Screening rate at 3, 6,9 months
Time frame: during the intervention; immediately after the intervention
Screening rate of patients with HTN/ type 2 DM:% patients with HTN/ type 2 DM screened among those who have ever screened blood pressure/blood sugar.Data will be obtained from administrative record.
Diagnostic rate change：Change from Baseline Diagnostic rate at 3, 6,9 months
Time frame: during the intervention; immediately after the intervention
Diagnostic rate of patients with HTN/ type 2 DM:% patients with HTN/ type 2 DM diagnosed among those who have been screened blood pressure/blood sugar.Data will be obtained from administrative record.
Treatment rate change：Change from Baseline Treatment rate at 3, 6,9 months
Time frame: during the intervention; immediately after the intervention
Treatment rate of patients with HTN:% patients with HTN who took antihypertensive drugs in the last two weeks was determined among those who have been diagnosed blood pressure; Treatment rate of patients with type 2 DM:% patients with type 2 DM who have taken treatment measures (including lifestyle intervention and/or medication) among those who have been diagnosed blood sugar.Data will be obtained from administrative record.
Control rate change：Change from Baseline Control rate at 3, 6,9 months
Time frame: during the intervention; immediately after the intervention
Control rate of patients with HTN/type 2 DM:% patients whose blood pressure/ blood sugar are controlled among those who have been treated.Data will be obtained from administrative record.
Implementation strategies use change: Change from Baseline Implementation at 3, 6,9 months
Time frame: during the intervention; immediately after the intervention
Implementation strategies use:qualitative interviews with managers of health centers.Interviews method will be used to assess this outcome measure.
Supervision change: Change from Baseline Implementation at 3, 6,9 months
Time frame: during the intervention; immediately after the intervention
Supervision model: % scheduled supervision field visits completed.Data will be obtained from administrative data.
Referral completeness change: Change from Baseline Implementation at 3, 6,9 months
Time frame: during the intervention; immediately after the intervention
Referral completeness: % referrals completed as prescribed by the clinical algorithm.Data will be obtained from administrative data.
Adaptations to protocol change: Change from Baseline Implementation at 3, 6,9 months
Time frame: during the intervention; immediately after the intervention
Adaptations to protocol during intervention period: qualitative interviews with managers of local health department and health centers.Interviews method will be used to assess this outcome measure.
Implementation change: Change from Baseline Implementation at 3, 6,9 months
Time frame: during the intervention; immediately after the intervention
Qualitative assessment: qualitative interviews with managers of health.Interviews method will be used to assess this outcome measure.
21 secondary outcomes
Coverage change: Change from Baseline Reach at 3, 6,9 months
Time frame: during the intervention; immediately after the intervention
Screening coverage of eligible for HTN change: Change from Baseline Reach at 3, 6,9 months
Time frame: during the intervention; immediately after the intervention
Screening coverage of eligible for type 2 DM change: Change from Baseline Reach at 3, 6,9 months
Time frame: during the intervention; immediately after the intervention
Coverage of screening for patients with HTN/type 2 DM change: Change from Baseline Reach at 3, 6,9 months
Time frame: during the intervention; immediately after the intervention
Readiness change: Change from Baseline Adoption at 3, 6,9 months
Time frame: during the intervention; immediately after the intervention
Health centers/clinic's adoption change: Change from Baseline Adoption at 3, 6,9 months
Time frame: during the intervention; immediately after the intervention
PHC professional's adoption change: Change from Baseline Adoption at 3, 6, 9 months
Time frame: during the intervention; immediately after the intervention
Timely adoption
Time frame: during the intervention
Leader adoption change: Change from Baseline Adoption at 3, 6,9 months
Time frame: during the intervention; immediately after the intervention
Institution adoption change: Change from Baseline Adoption at 3, 6,9 months
Time frame: during the intervention; immediately after the intervention
Follow-up fidelity change: Change from Baseline Fidelity at at 3, 6,9 months
Time frame: during the intervention; immediately after the intervention
Health professionals implemented guidelines/protocol change: Change from Baseline Fidelity at at 3, 6,9 months
Time frame: during the intervention; immediately after the intervention
Qualitative assessment-Behavior changes sustained (staff)
Time frame: 15 months
HTN and type 2 DM institutionalized
Time frame: immediately after the intervention
Settings continue the intervention
Time frame: immediately after the intervention
Total intervention cost
Time frame: immediately after the intervention
Total treatment cost
Time frame: immediately after the intervention
Intervention maintenance costs
Time frame: immediately after the intervention
Facility vs. community costs
Time frame: immediately after the intervention
out-of-pocket patient costs
Time frame: immediately after the intervention
Qualitative assessment-maintenance:
Time frame: immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
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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 Implementation strategies in people with Hypertension and Diabetes Mellitus, Type 2, run by National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC 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?
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: status not confirmed, as of the sponsor's last update on 29 Apr 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 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?
Results are not available in the source record.
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?
Awareness change：Change from Baseline Awareness at 3, 6,9 months (time frame: during the intervention; immediately after the intervention). The study lists 10 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 29 Apr 2022.