Helping Relationship From Significant Others in Patients With Hypertension

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: Completed
• Conditions: Hypertension; Significant Others
• Intervention / Treatment: Behavioral: Helping relationship from significant others; Behavioral: Usual team

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: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Medication Adherence	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	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	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

Outcome Measure	Measure Description	Time Frame
Blood pressure measurement	We will ask patients record blood pressure at home and compare with office blood pressure monitoring.	3 months

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Investigators: Study Chair: Yu Syuan Huang, master's student

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2025
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): March 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: hypertension; significant others; medical adherence; healthy lifestyles; helping relationship
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID 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