NCT06521242

Brief Summary

The study was conducted to examine the effects of the training given according to the Roy Adaptation Model on the sleep and quality of life of individuals with hypertension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

1.4 years

First QC Date

June 26, 2024

Last Update Submit

July 24, 2024

Conditions

Keywords

NursingHypertensionRoy Adaptation ModelSleep QualityQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Pittsburg Sleep Quality Index (PSQI)

    The index was developed by Buysse et al. in 1989 to evaluate the sleep duration and intensity of individuals. The scale has 11 items and 7 sub-dimensions. These items are scored between 0-3. The scores that can be obtained from the scale range from "0" to "21" points. The Turkish validity and reliability of the scale was conducted by Ağargün et al. in 1996. A high total scale score indicates poor sleep quality. A reliable, valid, and standard measurement of sleep quality is made with PSQI. The Cronbach Alpha Internal Consistency Coefficient of the scale is 0.80.

    up to eight weeks

Secondary Outcomes (1)

  • SF-36 Quality of Life Scale

    up to eight weeks

Study Arms (2)

Patient Education

EXPERIMENTAL

The RAM-Based Training and Hypertension Training Manual were given to the intervention group for 8 weeks, once a week, for 2 hours each session. The patients in the intervention group were called during the 1st and 3rd weeks of the study, and telephone counseling was provided. Reminders were made for important points in RAM-based hypertension training in these meetings.

Other: Patient Education

Control Group

NO INTERVENTION

Routine nursing care was given to the patients in this group without any training.

Interventions

The intervention group was given 120 minutes of training.

Patient Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being diagnosed with hypertension for at least 6 months
  • Having applied to clinics for follow-ups
  • Knowing the diagnosis and being able to express it verbally
  • Not having a communication problem
  • Being literate

You may not qualify if:

  • Incomplete data form
  • Leaving the study at any stage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkey

Erzurum, Yakutiye, 25100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HypertensionSleep Initiation and Maintenance Disorders

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass. Prof.

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 25, 2024

Study Start

July 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 26, 2022

Last Updated

July 25, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations