Clinical trial NCT06640751: The Effect of Interventions for Health Behaviors in Hypertensive Patients
Official title: The Effect of Interventions for Health Behaviors in Hypertensive Patients -Based on the PRECEDE-PROCEED Model
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Health Behavior
Public Health
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Hypertension is a major risk factor for cardiovascular disease, chronic kidney disease, and premature death worldwide. With an aging population and changes in dietary patterns and lifestyles, the prevalence of hypertension is rising globally, especially in developing countries. Hypertension is the most common chronic disease and a growing public health problem in China. A recent study estimated the prevalence of hypertension to be 28.56 % ± 10.44 %, ranging from 14.28% to 44.28% among the Chinese population aged over 15 years. The PRECEED-PROCEDE model provides a framework to help health planners and policymakers design effective health interventions based on evaluation and analysis of situations. This model has been used in different recent studies related to behavioral change. The study aims to examine the effectiveness of interventions for health behaviors in hypertensive patients based on the PRECEDE-PROCEED model.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with mild to moderate primary hypertension according to the diagnostic criteria of the "2018 Revised Edition of the Chinese Guidelines for the Prevention and Treatment of Hypertension," whose blood pressure is not well controlled or who have poor treatment compliance;
2. Age greater than 18 years and less than 80 years;
3. Normal language communication ability and willingness to participate in the study;
4. Have lived in the community for at least 12 months.

Exclusion Criteria:

1. Patients who lack basic behavioral abilities, have impaired memory function, or have limited language expression abilities;
2. Patients who are simultaneously participating in other intervention studies.

Primary outcomes:
measure: Health behavior
timeFrame: 1. Before the intervention: Baseline 2. During the intervention (at the end of the 3th, 6th month of the study) 3. the follow-up test (posttests - at the end of the 9th month of the study)
measure: systolic blood pressure
timeFrame: 1. Before the intervention: Baseline 2. During the intervention (at the end of the 3th, 6th month of the study) 3. the follow-up test (posttests - at the end of the 9th month of the study)
measure: Delay discounting
timeFrame: 1. Before the intervention: Baseline 2. During the intervention (at the end of the 3th, 6th month of the study) 3. the follow-up test (posttests - at the end of the 9th month of the study)
Secondary outcomes:
measure: Knowledge of hypertension
timeFrame: 1. Before the intervention: Baseline 2. During the intervention (at the end of the 3th, 6th month of the study) 3. the follow-up test (posttests - at the end of the 9th month of the study)
measure: Reinforcing factors
timeFrame: 1. Before the intervention: Baseline 2. During the intervention (at the end of the 6th month of the study) 3. the follow-up test (posttests - at the end of the 9th month)
measure: Enabling factors
timeFrame: 1. Before the intervention: Baseline 2. During the intervention (at the end of the 6th month of the study) 3. the follow-up test (posttests - at the end of the 9th month)
measure: Self-efficacy
timeFrame: 1. Before the intervention: Baseline 2. During the intervention (at the end of the 3th, 6th month of the study) 3. the follow-up test (posttests - at the end of the 9th month)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Community health service center
state: Jiangsu
Study officials:
References: