Helping Relationship From Significant Others in Patients With Hypertension

April 6, 2026 updated by: National Cheng-Kung University Hospital

Effects of Helping Relationship From Significant Others in Patients With Hypertension Adhere to Healthy Lifestyles and Medication.

The goal of this clinical trial is to learn if helping relationship from significant others in patients with hypertension improve the adherence to healthy lifestyles and medication. The main questions it aims to answer:

Does helping relationship from significant others improve in patients with hypertension the adherence to healthy lifestyles and medication? Is helping relationship from significant others helpful to patients with hypertension?

Researchers will compare helping relationship from significant others with routine care to see if the intervention works to improve hypertension.

Participants and their significant others will be participate in this study.

Significant others will prompt participants about:

Take the medicine according to the prescription. Sodium restriction Alcohol limitation Body weight reduction Cigarette smoke cessation Diet adaptation Exercise adoption

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

With an increasing prevalence of Hypertension around the world, chronic disease management has become an optimal issue. There are many components about hypertension management, such as diet, exercise, medication adherence and social support. As the current pandemic situation and the shortage of healthcare providers, the patients must be aware of health condition themselves. Researchers need more efficacious approaches to achieve better hypertension management. Due to the traditional methods can't lead to better disease management, social support might improve the blood pressure control and their poor adherence to treatment.

This study aims to develop helping relationship from significant others in patients with Hypertension adhere to healthy lifestyles. Researchers plan to recruit patients in southern Taiwan medical center. Those who aged 18 years and over, diagnosed hypertension, taking at least one western antihypertensive medication once a day and those who have significant others. The trial will conduct in a medical center as a quasi-experimental study. Patients will be divide into two groups. Patients will all recept the knowledge of Hypertension. The intervention group will receive another information about how they conduct their helping relationship as significant others. After intervention, researchers will compare the blood pressure, medication adherence, lifestyles and helping relationship between intervention and control groups. All data will be analyzed by using SPSS.

The helping relationship by significant others would be beneficial to hypertension management. Participants are willing to control their blood pressure and reveal more consideration for their health.

Chronic disease depends on not only self efficacy but also the whole family support. With helping relationship by significant others, researchers can adjust care plan according to individual needs. Hope to reach the goal of whole person care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
133

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be diagnosed with Hypertension
  • Patients with Hypertension those who accompanied with their significant other
  • Clear consciousness and able to communicate with Mandarine or Taiwanese
  • Willing to participate in this project
  • Bring their own blood pressure monitor
  • Currently taking at least one Western antihypertensive medication once/day

Exclusion Criteria:

  • Without taking any medication of hypertension
  • Acute medical issue
  • Be diagnosed with Cognitive deficiency
  • Currently join another research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Helper team
Significant others of patient will practice strategies of helping relationship to help patients improve their health condition.
Behavioral: Helping relationship from significant others
Helping relationship from significant others is the intervention of this study. We will use four strategies, including warning mechanisms, target setting, encouragement, and feedback.
Placebo Comparator: Usual team
Patients of this team accept usual care
Behavioral: Usual team
Patients of this team accept usual care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Medication Adherence
Time Frame: 3 months
Medication adherence was measured using the Medication Adherence Scale (MAS). The scale consists of 8 items, with each item rated on a 5-point Likert scale ranging from 1 to 5. Total scores are calculated by summing all item responses, resulting in a possible score range of 8 to 40. Higher scores indicate better medication adherence, reflecting greater consistency in following prescribed antihypertensive medication regimens.
3 months
Health promotion lifestyle
Time Frame: 3 months
Health-promoting lifestyle was assessed using the Health-Promoting Lifestyle Profile II (HPLP-II). The HPLP-II consists of 52 items measuring engagement in health-promoting behaviors across multiple domains, including health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management. Each item is rated on a 4-point Likert scale ranging from 1 (never) to 4 (routinely). Total scores range from 52 to 208, with higher scores indicating better health-promoting lifestyle behaviors.
3 months
Helping Relationships From Significant Others
Time Frame: 3 months
Perceived helping relationship was assessed using the Helping Relationship Scale of Significant Others (HRSOS) developed by Chao et al. This instrument measures the degree of perceived support provided by significant others in the context of health behavior change, including understanding, encouragement, and companionship. Items are rated on a Likert scale, with total scores ranging from [minimum score] to [maximum score]. Higher scores indicate a stronger perceived helping relationship.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood pressure measurement
Time Frame: 3 months
We will ask patients record blood pressure at home and compare with office blood pressure monitoring.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cheng-Kung University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yu Syuan Huang, master's student

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NCKUH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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