HypertensionACTIVATENCT06480487
Optimize Audit and feedbaCk To Implement eVidence-based prAcTices in Primary Health carE
A study testing Feedback provided face to face, Feedback provided by electronic mail and Feedback provided by researchers in people with Hypertension and Diabetes, run by Southern Medical University, China.
Trial summary
The investigators will use two phases of Multiphase Optimization Strategy (MOST) - preparation and optimization phases. In the preparation phase, Audit and Feedback (AnF) intervention will be prepared. First, the investigators will use scoping review to develop conceptual frameworks for AnF components. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Diabetes
- What is being tested?
- Feedback provided face to face, Feedback provided by electronic mail and Feedback provided by researchers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- No sites listed yet
- Study dates
- May 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In Mozambique, the inclusion criteria are nurses, technicians of general medicine and doctors in public primary healthcare facilities.
- In Zanzibar, Tanzania, the inclusion criteria are clinical officers, nurses and doctors in public primary healthcare facilities.
- In Nepal, the inclusion criteria are doctors, health assistants, and senior auxiliary health workers in public primary healthcare facilities.
- In China, the inclusion criteria are doctors practicing in public primary healthcare facilities.
Who cannot join
- -The exclusion criteria are endocrinologists or diabetes specialists, interns, or students working during the time of visit.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Optimize Audit and feedbaCk To Implement eVidence-based prAcTices in Primary Health carE in Nepal, Mozambique, Tanzania and China: a Factorial Trial (ACTIVATE Trial)
The investigators will use two phases of Multiphase Optimization Strategy (MOST) - preparation and optimization phases. In the preparation phase, Audit and Feedback (AnF) intervention will be prepared. First, the investigators will use scoping review to develop conceptual frameworks for AnF components. The outcome indicators and resource constraints for intervention will be identified based on the literature reviews. Second, an expert consultation meeting will be conducted to develop a set of candidate components for the AnF intervention. Around 10 relevant scholars and primary healthcare workers will be invited to rank the components that researchers conclude from the literature. The top 7 ranked components will be assessed by Best-Worst Scaling (BWS) questionnaires to finally identify 3 key components for AnF intervention.
In the optimization phase, the investigators will identify AnF intervention that will lead to the best desired results within key resource constraints in terms of effectiveness , efficiency, economy and scalability. First, the investigators will realistically and comprehensively assess the quality of care provided by primary healthcare facilities of the four Low and Middle Income countries (LMICs) using USP. Second, a 2×2×2 factorial design (RCT) will be conducted to determine how the results of quality of care can be fed back to primary healthcare workers in the four LMICs in order to optimize the impact of improving healthcare quality. To achieve this goal, the factorial trial will involve the 3 identified key AnF components at 2 levels each, for a total of 8 intervention groups (i.e. 8 different ways to conduct audit and feedback). By randomly assigning healthcare facilities to one of these 8 different ways to conduct audit and feedback, the investigators can obtain the change in the quality of care after implementing audit and feedback interventions in these facilities. Then, through statistical analysis, the investigators can estimate main and interaction effects for AnF components on improving the quality of primary health care. After that, the optimal combination of AnF components will be determined by trade off of the effects of AnF components and resource constraints in local primary healthcare implementation settings. Study details are as follows.
Read the detailed description
Researchers and experts will have a consultation meeting to generate the top 7 AnF intervention components, and a BWS survey will be employed to rank these components according to their importance and further select 3 potentially most effective and feasible components for effectiveness validation through the factorial trial in the next step. The BWS survey is a screening experiment, based on random utility theory, in which a trade-off mechanism is triggered by participants choosing the best and worst of a set of components or options, thereby quantifying the relative importance of each component and distinguishing the most salient among a set of important components. The BWS questionnaire will be developed and tested using a mixed-method approach based on the previous research results to obtain healthcare workers' prioritized acceptance of the different AnF components (relative importance) when deciding to improve the quality of care (completion rates of guideline entries), in order to further identify potentially the most important few components out of the range of components.
The Balanced Incomplete Block Design (BIBD) is an experimental design used in BWS for improving results by organizing items into blocks and balancing the number of presentations of items across participants, which allows researchers to efficiently compare a set of items with each other. BIBD ensures equal number of times of occurrence for items in blocks and pairs items equally, reducing bias and increasing statistical precision of ratings. BIBD is especially valuable with a larger number of ranked items. The investigators will use BIBD in BWS in a typical way, by dividing items randomly into subsets (i.e. blocks) and assigning a questionnaire with all blocks to each participant, ensuring robust preference rankings. The investigators will use the %MktBSize macro in SAS 9.4 software to realize BIBD for questionnaire development. In our study, for the 7 AnF intervention components (treatments), the investigators will have 7 different blocks, each containing 3 AnF components (treatments). the investigators will invite participants to reflect on which AnF component of these 7 different blocks is most effective and which AnF component is least effective. The investigators will be giving 1 point when a component is chosen as most effective, and -1 when a component is chosen as least effective. Then, based on the standardized score of each component, the investigators will be finalizing the 3 most effective components from the BWS survey.
In the optimization phase, a 2×2×2 factorial design (RCT) will be conducted, with three two-level components making up a total of 8 groups of AnF intervention. After obtaining consents from primary healthcare facilities and workers, all facilities will be randomly assigned to these 8 intervention groups. Then the investigators measure changes in healthcare quality from various audits and feedback in these facilities, and use statistical analysis to estimate main and interaction effects for AnF components on improving primary healthcare quality. The optimal AnF combination will be determined by considering effects and resource constraints in local implementation settings.
The investigators assume that the following 3 AnF components with 2 levels each are selected from the BWS survey.
- Source of Feedback: Level 1: Researchers Level 2: Authoritative Bodies
- Feedback with Peer Comparison: Level 1: Yes (Peer Comparison) Level 2: No (No Peer Comparison)
- Delivery Method of Feedback:
Level 1: Face to face Level 2: Electronic Mail
After deciding the 8 AnF intervention groups, the investigators will invite primary healthcare workers, policymakers, and health system administrators to discuss feasible and operable details to conduct the 8 AnF interventions at primary healthcare facilities in the four different LMICs. The audited results of quality of care of the facility will be fed back to the healthcare workers of the facility, and then the outcome indicators reflecting effectiveness of AnF will be measured.
- Conditions
- Hypertension, Diabetes
- Being tested
- Feedback provided face to face, Feedback provided by electronic mail, Feedback provided by researchers, Feedback provided by authoritative bodies, Feedback provided with peer comparision
- Keywords
- Audit and feedback, Quality of care, Primary health care
- 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.
Feedback provided face to faceBehavioural
Feedback will be provided face-to-face.
Feedback provided by electronic mailBehavioural
Feedback will be provided by electronic mail.
Feedback provided by researchersBehavioural
Feedback will be provided by researchers.
Feedback provided by authoritative bodiesBehavioural
Feedback will be provided by authoritative bodies.
Feedback provided with peer comparisionBehavioural
Feedback will be provided with peer comparison.
Feedback provided without peer comparisionBehavioural
Feedback will be provided without peer comparision.
| Study group | Role | What they receive |
|---|---|---|
| Face to face by researchers with peer comparision | Experimental | Feedback will be provided face-to-face by the researchers by visiting health facilities. The feedback report will include peer comparison data. Receives: Behavioral: Feedback provided face to face; Behavioral: Feedback provided by researchers; Behavioral: Feedback provided with peer comparision |
| Face to face by authoritative bodies with peer comparision | Experimental | Feedback will be provided face-to-face by the authoritative bodies by visiting health facilities. The feedback report will include peer comparison data. Receives: Behavioral: Feedback provided face to face; Behavioral: Feedback provided by authoritative bodies; Behavioral: Feedback provided with peer comparision |
| Face to face by researchers without peer comparision | Experimental | Feedback will be provided face-to-face by the researchers by visiting health facilities. The feedback report will not include peer comparison data. Receives: Behavioral: Feedback provided face to face; Behavioral: Feedback provided by researchers; Behavioral: Feedback provided without peer comparision |
| Electronic mail by researchers with peer comparision | Experimental | Feedback will be provided through electronic mail by the researchers. The feedback report will include peer comparison data. Receives: Behavioral: Feedback provided by electronic mail; Behavioral: Feedback provided by researchers; Behavioral: Feedback provided with peer comparision |
| Face to face by authoritative bodies without peer comparision | Experimental | Feedback will be provided face-to-face by the authoritative bodies by visiting health facilities. The feedback report will not include peer comparison data. Receives: Behavioral: Feedback provided face to face; Behavioral: Feedback provided by authoritative bodies; Behavioral: Feedback provided without peer comparision |
| Electronic mail by authoritative bodies with peer comparision | Experimental | Feedback will be provided through electronic mail by the authoritative bodies. The feedback report will include peer comparison data. Receives: Behavioral: Feedback provided by electronic mail; Behavioral: Feedback provided by authoritative bodies; Behavioral: Feedback provided with peer comparision |
| Electronic mail by researchers without peer comparision | Experimental | Feedback will be provided through electronic mail by the researchers. The feedback report will not include peer comparison data. Receives: Behavioral: Feedback provided by electronic mail; Behavioral: Feedback provided by researchers; Behavioral: Feedback provided without peer comparision |
| Electronic mail by authoritative bodies without peer comparision | Experimental | Feedback will be provided through electronic mail by the authoritative bodies. The feedback report will not include peer comparison data. Receives: Behavioral: Feedback provided by electronic mail; Behavioral: Feedback provided by authoritative bodies; Behavioral: Feedback provided without peer comparision |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of completed guideline-recommended quality checklist items for consultation of hypertension cases and Type II diabetes cases of the primary healthcare (PHC) providers among all of the items
The primary outcome is a continuous score ranging from 0 to 100%. It will be assessed by Unannounced Standardized Patients (USPs).
Measured: An average of 1 month and 3 months
Secondary outcomes (8)
The proportion of completed guideline-recommended quality checklist items for physical and laboratory exams of hypertension cases and Type II diabetes cases of the PHC providers among all of the items
This is a continuous score ranging from 0 to 100%. It will be assessed by USPs.
Measured: An average of 1 month and 3 months
Correctness of diagnosis of hypertension cases and type II diabetes cases by PHC providers
This will be categorized into 2 categories: correct diagnosis, and incorrect diagnosis. It will be assessed by USPs.
Measured: An average of 1 month and 3 months
Correctness of treatment of hypertension cases and type II diabetes cases by PHC providers
This will be categorized into 2 categories: correct treatment, and incorrect treatment. It will be assessed by USPs.
Measured: An average of 1 month and 3 months
Timeliness of hypertension and type II diabetes services in primary healthcare settings.
Timeliness of hypertension and type II diabetes will be assessed by USPs by using Quality of care assessment tools. Timeliness will be judged on the basis of opening hours, waiting time, and consultation time of the service.
Measured: An average of 1 month and 3 months
Patient-centered quality of healthcare in primary healthcare settings.
Patient-centered quality of healthcare will be assessed by USPs using Patient Perception of Patient-Centeredness (PPPC-R) questionnaire.
Measured: An average of 1 month and 3 months
Implementation outcome: Adoption of Audit and Feedback (AnF) intervention by study participants
It is a dichotomous variable, consisting of two categories: adopted, not adopted. It will be self-reported by participants using team-developed questionnaire.
Measured: An average of 3 months
Implementation outcome: Costs to researchers of developing and implementing Audit and Feedback (AnF) intervention
It is a continuous variable and will be assessed using project final account of expenditure
Measured: An average of 3 months
Implementation outcome: Participants score of acceptability of AnF intervention
It will be self-reported by participants using Generic Theoretical Framework of Acceptability (TFA)-based questionnaire.
Measured: An average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study startMay 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Oct 2025 (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
- Model description
- A 2×2×2 factorial design will be conducted, with three two-level components making up a total of 8 groups of AnF interventions. The sample population will be randomly assigned to these 8 intervention groups, stratified by countries and regions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Huanyuan Luo, Southern Medical University, China
- Investigators
- Dong Xu, Study director, Southern Medical Univerity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480487
- Sponsor's protocol ID
- ACTIVATE
- Acronym
- ACTIVATE
- Status last verified
- Apr 2025
- First submitted
- 17 Jun 2024
- Last updated
- 27 Apr 2025
- 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 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimize Audit and feedbaCk To Implement eVidence-based prAcTices in Primary Health carE in Nepal, Mozambique, Tanzania and China: a Factorial Trial (ACTIVATE Trial)
- ClinicalTrials.gov ID
- NCT06480487
- Acronym / sponsor ID
- ACTIVATE / ACTIVATE
- Conditions
- Hypertension, Diabetes
- Keywords
- Audit and feedback, Quality of care, Primary health care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Southern Medical University, ChinaUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 28 Jun 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 investigators will use two phases of Multiphase Optimization Strategy (MOST) - preparation and optimization phases. In the preparation phase, Audit and Feedback (AnF) intervention will be prepared. First, the investigators will use scoping review to develop conceptual frameworks for AnF components. The outcome indicators and resource constraints for intervention will be identified based on the literature reviews. Second, an expert consultation meeting will be conducted to develop a set of candidate components for the AnF intervention. Around 10 relevant scholars and primary healthcare workers will be invited to rank the components that researchers conclude from the literature. The top 7 ranked components will be assessed by Best-Worst Scaling (BWS) questionnaires to finally identify 3 key components for AnF intervention.
In the optimization phase, the investigators will identify AnF intervention that will lead to the best desired results within key resource constraints in terms of effectiveness , efficiency, economy and scalability. First, the investigators will realistically and comprehensively assess the quality of care provided by primary healthcare facilities of the four Low and Middle Income countries (LMICs) using USP. Second, a 2×2×2 factorial design (RCT) will be conducted to determine how the results of quality of care can be fed back to primary healthcare workers in the four LMICs in order to optimize the impact of improving healthcare quality. To achieve this goal, the factorial trial will involve the 3 identified key AnF components at 2 levels each, for a total of 8 intervention groups (i.e. 8 different ways to conduct audit and feedback). By randomly assigning healthcare facilities to one of these 8 different ways to conduct audit and feedback, the investigators can obtain the change in the quality of care after implementing audit and feedback interventions in these facilities. Then, through statistical analysis, the investigators can estimate main and interaction effects for AnF components on improving the quality of primary health care. After that, the optimal combination of AnF components will be determined by trade off of the effects of AnF components and resource constraints in local primary healthcare implementation settings. Study details are as follows.
Detailed description
Researchers and experts will have a consultation meeting to generate the top 7 AnF intervention components, and a BWS survey will be employed to rank these components according to their importance and further select 3 potentially most effective and feasible components for effectiveness validation through the factorial trial in the next step. The BWS survey is a screening experiment, based on random utility theory, in which a trade-off mechanism is triggered by participants choosing the best and worst of a set of components or options, thereby quantifying the relative importance of each component and distinguishing the most salient among a set of important components. The BWS questionnaire will be developed and tested using a mixed-method approach based on the previous research results to obtain healthcare workers' prioritized acceptance of the different AnF components (relative importance) when deciding to improve the quality of care (completion rates of guideline entries), in order to further identify potentially the most important few components out of the range of components.
The Balanced Incomplete Block Design (BIBD) is an experimental design used in BWS for improving results by organizing items into blocks and balancing the number of presentations of items across participants, which allows researchers to efficiently compare a set of items with each other. BIBD ensures equal number of times of occurrence for items in blocks and pairs items equally, reducing bias and increasing statistical precision of ratings. BIBD is especially valuable with a larger number of ranked items. The investigators will use BIBD in BWS in a typical way, by dividing items randomly into subsets (i.e. blocks) and assigning a questionnaire with all blocks to each participant, ensuring robust preference rankings. The investigators will use the %MktBSize macro in SAS 9.4 software to realize BIBD for questionnaire development. In our study, for the 7 AnF intervention components (treatments), the investigators will have 7 different blocks, each containing 3 AnF components (treatments). the investigators will invite participants to reflect on which AnF component of these 7 different blocks is most effective and which AnF component is least effective. The investigators will be giving 1 point when a component is chosen as most effective, and -1 when a component is chosen as least effective. Then, based on the standardized score of each component, the investigators will be finalizing the 3 most effective components from the BWS survey.
In the optimization phase, a 2×2×2 factorial design (RCT) will be conducted, with three two-level components making up a total of 8 groups of AnF intervention. After obtaining consents from primary healthcare facilities and workers, all facilities will be randomly assigned to these 8 intervention groups. Then the investigators measure changes in healthcare quality from various audits and feedback in these facilities, and use statistical analysis to estimate main and interaction effects for AnF components on improving primary healthcare quality. The optimal AnF combination will be determined by considering effects and resource constraints in local implementation settings.
The investigators assume that the following 3 AnF components with 2 levels each are selected from the BWS survey.
- Source of Feedback: Level 1: Researchers Level 2: Authoritative Bodies
- Feedback with Peer Comparison: Level 1: Yes (Peer Comparison) Level 2: No (No Peer Comparison)
- Delivery Method of Feedback:
Level 1: Face to face Level 2: Electronic Mail
After deciding the 8 AnF intervention groups, the investigators will invite primary healthcare workers, policymakers, and health system administrators to discuss feasible and operable details to conduct the 8 AnF interventions at primary healthcare facilities in the four different LMICs. The audited results of quality of care of the facility will be fed back to the healthcare workers of the facility, and then the outcome indicators reflecting effectiveness of AnF will be measured.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
- Model description
- A 2×2×2 factorial design will be conducted, with three two-level components making up a total of 8 groups of AnF interventions. The sample population will be randomly assigned to these 8 intervention groups, stratified by countries and regions.
| Arm | Type | Receives |
|---|---|---|
| Face to face by researchers with peer comparision | Experimental | Behavioral: Feedback provided face to face, Behavioral: Feedback provided by researchers, Behavioral: Feedback provided with peer comparisionFeedback will be provided face-to-face by the researchers by visiting health facilities. The feedback report will include peer comparison data. |
| Face to face by authoritative bodies with peer comparision | Experimental | Behavioral: Feedback provided face to face, Behavioral: Feedback provided by authoritative bodies, Behavioral: Feedback provided with peer comparisionFeedback will be provided face-to-face by the authoritative bodies by visiting health facilities. The feedback report will include peer comparison data. |
| Face to face by researchers without peer comparision | Experimental | Behavioral: Feedback provided face to face, Behavioral: Feedback provided by researchers, Behavioral: Feedback provided without peer comparisionFeedback will be provided face-to-face by the researchers by visiting health facilities. The feedback report will not include peer comparison data. |
| Electronic mail by researchers with peer comparision | Experimental | Behavioral: Feedback provided by electronic mail, Behavioral: Feedback provided by researchers, Behavioral: Feedback provided with peer comparisionFeedback will be provided through electronic mail by the researchers. The feedback report will include peer comparison data. |
| Face to face by authoritative bodies without peer comparision | Experimental | Behavioral: Feedback provided face to face, Behavioral: Feedback provided by authoritative bodies, Behavioral: Feedback provided without peer comparisionFeedback will be provided face-to-face by the authoritative bodies by visiting health facilities. The feedback report will not include peer comparison data. |
| Electronic mail by authoritative bodies with peer comparision | Experimental | Behavioral: Feedback provided by electronic mail, Behavioral: Feedback provided by authoritative bodies, Behavioral: Feedback provided with peer comparisionFeedback will be provided through electronic mail by the authoritative bodies. The feedback report will include peer comparison data. |
| Electronic mail by researchers without peer comparision | Experimental | Behavioral: Feedback provided by electronic mail, Behavioral: Feedback provided by researchers, Behavioral: Feedback provided without peer comparisionFeedback will be provided through electronic mail by the researchers. The feedback report will not include peer comparison data. |
| Electronic mail by authoritative bodies without peer comparision | Experimental | Behavioral: Feedback provided by electronic mail, Behavioral: Feedback provided by authoritative bodies, Behavioral: Feedback provided without peer comparisionFeedback will be provided through electronic mail by the authoritative bodies. The feedback report will not include peer comparison data. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- In Mozambique, the inclusion criteria are nurses, technicians of general medicine and doctors in public primary healthcare facilities.
- In Zanzibar, Tanzania, the inclusion criteria are clinical officers, nurses and doctors in public primary healthcare facilities.
- In Nepal, the inclusion criteria are doctors, health assistants, and senior auxiliary health workers in public primary healthcare facilities.
- In China, the inclusion criteria are doctors practicing in public primary healthcare facilities.
Key exclusion criteria (1 listed)
- -The exclusion criteria are endocrinologists or diabetes specialists, interns, or students working during the time of visit.
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 |
|---|---|---|
| Feedback provided face to faceFeedback will be provided face-to-face. | Behavioural | Face to face by authoritative bodies with peer comparision, Face to face by authoritative bodies without peer comparision, Face to face by researchers with peer comparision, Face to face by researchers without peer comparision |
| Feedback provided by electronic mailFeedback will be provided by electronic mail. | Behavioural | Electronic mail by authoritative bodies with peer comparision, Electronic mail by authoritative bodies without peer comparision, Electronic mail by researchers with peer comparision, Electronic mail by researchers without peer comparision |
| Feedback provided by researchersFeedback will be provided by researchers. | Behavioural | Electronic mail by researchers with peer comparision, Electronic mail by researchers without peer comparision, Face to face by researchers with peer comparision, Face to face by researchers without peer comparision |
| Feedback provided by authoritative bodiesFeedback will be provided by authoritative bodies. | Behavioural | Electronic mail by authoritative bodies with peer comparision, Electronic mail by authoritative bodies without peer comparision, Face to face by authoritative bodies with peer comparision, Face to face by authoritative bodies without peer comparision |
| Feedback provided with peer comparisionFeedback will be provided with peer comparison. | Behavioural | Electronic mail by authoritative bodies with peer comparision, Electronic mail by researchers with peer comparision, Face to face by authoritative bodies with peer comparision, Face to face by researchers with peer comparision |
| Feedback provided without peer comparisionFeedback will be provided without peer comparision. | Behavioural | Electronic mail by authoritative bodies without peer comparision, Electronic mail by researchers without peer comparision, Face to face by authoritative bodies without peer comparision, Face to face by researchers without peer comparision |
Primary outcome
The proportion of completed guideline-recommended quality checklist items for consultation of hypertension cases and Type II diabetes cases of the primary healthcare (PHC) providers among all of the items
Time frame: An average of 1 month and 3 months
The primary outcome is a continuous score ranging from 0 to 100%. It will be assessed by Unannounced Standardized Patients (USPs).
8 secondary outcomes
The proportion of completed guideline-recommended quality checklist items for physical and laboratory exams of hypertension cases and Type II diabetes cases of the PHC providers among all of the items
Time frame: An average of 1 month and 3 months
Correctness of diagnosis of hypertension cases and type II diabetes cases by PHC providers
Time frame: An average of 1 month and 3 months
Correctness of treatment of hypertension cases and type II diabetes cases by PHC providers
Time frame: An average of 1 month and 3 months
Timeliness of hypertension and type II diabetes services in primary healthcare settings.
Time frame: An average of 1 month and 3 months
Patient-centered quality of healthcare in primary healthcare settings.
Time frame: An average of 1 month and 3 months
Implementation outcome: Adoption of Audit and Feedback (AnF) intervention by study participants
Time frame: An average of 3 months
Implementation outcome: Costs to researchers of developing and implementing Audit and Feedback (AnF) intervention
Time frame: An average of 3 months
Implementation outcome: Participants score of acceptability of AnF intervention
Time frame: An average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Dong Xu study director
Southern Medical Univerity
Questions about this trial
What is this clinical trial studying?
A study testing Feedback provided face to face, Feedback provided by electronic mail and Feedback provided by researchers in people with Hypertension and Diabetes, run by Southern Medical University, 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 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: opening soon, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huanyuan Luo (+8618215827985, huanyuanluo33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of completed guideline-recommended quality checklist items for consultation of hypertension cases and Type II diabetes cases of the primary healthcare (PHC) providers among all of the items (time frame: An average of 1 month and 3 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 27 Apr 2025.