Helping Relationship From Significant Others in Patients With Hypertension

NCT06854926 | Completed DMC

• 1 other identifier: NCKUH
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension; Significant Others

Keywords

hypertension; significant others; helping relationship; healthy lifestyles; medical adherence

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Blood pressure measurement

  3 months

Study Arms (2)

Helper team

EXPERIMENTAL

Significant others of patient will practice strategies of helping relationship to help patients improve their health condition.

Behavioral: Helping relationship from significant others

Usual team

PLACEBO COMPARATOR

Patients of this team accept usual care

Behavioral: Usual team

Interventions

Usual team BEHAVIORAL

Patients of this team accept usual care

Usual team

Helping relationship from significant others BEHAVIORAL

Helping relationship from significant others is the intervention of this study. We will use four strategies, including warning mechanisms, target setting, encouragement, and feedback.

Helper team

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yu Syuan Huang

  master's student

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: patients with hypertension

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: April 17, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 9, 2026

Record last verified: 2026-03

Locations

TW (1)