NCT06350136

Brief Summary

This important research includes a randomized controlled trial evaluating the potential of self-management support provided via telenursing to earthquake-affected hypertension patients to improve patients' treatment adherence and overall self-care management. This study will be carried out at Fırat University Hospital and will cover a wide range of effects on health outcomes in individuals receiving hypertension treatment. The sample selected from hypertension patients, which constitute the population of the research, was based on predetermined power analysis criteria. It has been determined that at least 51 hypertension patients should be included in each of the intervention and control groups, and accordingly, a total of 150 hypertension patients will be included in the study. . The results obtained within this framework may provide guidance in the development and implementation of Turkey's health policies, and may also shed light on strategies for the management of other similar health problems. On the other hand, strengthening the digital health infrastructure and effective management of chronic diseases, which are among the health-related targets of the Development Plan, further emphasize the importance of this research. The success of the self-management model supported by tele-nursing can serve as an example in the integration of digital health technologies into Turkey's healthcare system and be an important step towards achieving strategic goals in this field.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

April 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

April 1, 2024

Last Update Submit

April 4, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Hill-Bone Hypertension Treatment Compliance Scale

    The scale consists of 14 questions. On a four-point Likert scale (0=never, 1=sometimes, 2=most of the time and 3=always), interview (items 6, 7 and 8), medical (items 1, 2, 9, 10, 11, 12, 13) and 14) and nutrition (items 3, 4 and 5). Except for the 6th question of the scale, all other questions are in the form of negative questions. Total scores from the scale vary between 0 and 42, with 0 points indicating perfect compliance with treatment. A high total score from the scale indicates decreased compliance with treatment.

    12 week

  • Self-Care Management Scale in Chronic Diseases;

    The scale consists of 35 items and is a five-point Likert type (1=strongly disagree, 2=disagree, 3=undecided, 4=agree, 5=strongly agree). The scale includes self-protection (items 2, 6, 8, 11, 15, 18, 19, 20, 22, 23, 25-34), and social protection (items 1, 3, 4, 5, 7, 9, 10, 12). It has two sub-dimensions: , 13, 14, 16, 17, 21, 24 and 35 items). The 3rd, 15th, 19th and 28th items in the scale are negative statements. The total scores that can be obtained from the scale vary between 35-175 points, and an increase in the score indicates that the individual's self-care management also increases.

    12 week

  • Psychological Impact of Earthquake Scale:

    The scale consists of 41 items. The scale is a 5-point Likert (1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree, 5: Strongly Agree). There are 6 sub-dimensions. As the score on the scale increases, the psychological impact of the earthquake on individuals increases. Scale Cronbach's Alpha values vary between 0.84 and 0.96.

    12 week

  • Earthquake Stress Coping Strategies Scale

    The scale consists of 16 items and has 3 subscales. A 4-point rating was used in the scale: Always (4) and Never (1). However, in the Social Support Seeking subscale, Item 4 (I try to keep my feelings to myself) and Item 12 (I prefer not to talk about my fears and concerns) are scored in the opposite direction because they indicate that the individual does not seek social support. The score ranges of the Religious Coping and Social Support Seeking subscales, each consisting of 5 items, are 5-20, and the score range of the Positive Reappraisal subscale, consisting of 6 items, is 6-24. A high score for each dimension indicates that the individual uses that coping strategy more, while a low score indicates that the individual uses it less

    12 week

Study Arms (2)

With Tele-Nursing

EXPERIMENTAL

With Tele-Nursing

Behavioral: With Tele-Nursing

Control

NO INTERVENTION

no With Tele-Nursing

Interventions

no With Tele-Nursing

Also known as: Control
With Tele-Nursing

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being followed for at least 6 months with the diagnosis of essential hypertension,
  • Patients diagnosed with hypertension who suffered financial or moral loss after the earthquake
  • Located in Elazığ at the time of the February 6 earthquake
  • Continuing to live in Elazığ after the earthquake
  • Using antihypertensive medication,
  • No change in antihypertensive drug treatment has been made in the last month,
  • Computer/tablet/smartphone etc. to watch videos. having technological devices,
  • Having internet access,
  • Being over 40 years old,
  • Education level must be at least primary education level

You may not qualify if:

  • Being pregnant or breastfeeding
  • Presence of another accompanying chronic disease (Diabetes mellitus, cancer, chronic renal failure, chronic obstructive pulmonary disease, heart failure, etc.),
  • Having physical (speech, hearing impairment, etc.), neurological and psychological problems that prevent filling out research forms and participating in training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Gülcan Bahçecioğlu Turan

CONTACT

Gülcan Bahçecioğlu Turan

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 1, 2024

First Posted

April 5, 2024

Study Start

June 1, 2024

Primary Completion

December 1, 2024

Study Completion

June 1, 2025

Last Updated

April 8, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share