NCT07462221

Brief Summary

This research will be conducted using a pre-test and post-test control group experimental design to evaluate the effect of telenursing intervention on oral health in individuals with COPD.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

Study Progress88%
Mar 2026Jun 2026

Study Start

First participant enrolled

March 4, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

Same day

First QC Date

March 5, 2026

Last Update Submit

March 5, 2026

Conditions

Keywords

oral healthtele-nursingCOPD

Outcome Measures

Primary Outcomes (2)

  • oral healt

    The Oral Assessment Guide (ADR) will be used to evaluate oral health. The guide supports the creation of an oral care protocol for patients with impaired oral mucosal membranes. Scores on the guide range from 8 to 24. According to the ADR, a low score indicates good oral health, while a high score indicates negative changes in oral health. The oral mucosal membrane score will be evaluated in both pre-test and post-test. A light source and a tongue depressor (one for each participant) are planned to be used during the oral health assessment.

    pre-test and post-test (1 month)

  • Quality of Life Related to Oral Health

    The scale has seven sub-dimensions: 'Functional Limitation', 'Physical Pain', 'Psychological Distress', 'Physical Disability', 'Psychological Disability', 'Social Disability', and 'Handicap'. Scores obtainable from the Oral Health Impact Scale range from 0 to 56. Since all questions are in a negative form, a score close to 0 indicates good quality of life related to oral and dental health, while a score close to 56 indicates poor quality of life related to oral and dental health. A high score on the scale indicates low quality of life related to oral health.

    pre-test and post-test (1 month)

Study Arms (2)

experimental group

EXPERIMENTAL

The experimental group will receive oral health education via telenursing intervention (via video call) and daily oral health reminders. Oral health education for the experimental group is planned to be given within 24 hours after the pre-test. Participants will also receive reminders regarding oral hygiene, including "performing oral care at least twice a day, every day" and "rinsing their mouths with water after using an inhaler." The experimental group will be invited to the hospital one month after the oral health education for evaluation of oral health and quality of life related to oral health.

Behavioral: telenursingBehavioral: reminders

control group

NO INTERVENTION

The control group will not receive training. They will be invited to the hospital for an oral health and quality of life check one month after the initial follow-up.

Interventions

telenursingBEHAVIORAL

The responsible researcher will provide oral health education to the experimental group via video call during the telenursing intervention. The content of the education will include oral health in adults; the consequences of poor oral hygiene; things to pay attention to in oral health; demonstration of toothbrushing technique; and coping with care-resistant behaviors. Participants' questions regarding oral health will be answered during the call. The oral health education session is planned to last approximately 20 minutes.

experimental group
remindersBEHAVIORAL

Participants in the experimental group will be reminded to perform oral care at least twice a day, every day, and to rinse their mouths with water after using an inhaler. They will also be reminded to schedule a face-to-face meeting one month after the education.

experimental group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must have been diagnosed with COPD for at least 6 months,
  • receive inpatient treatment in internal medicine and surgical clinics,
  • signed the informed consent form to participate in the study,
  • have internet access and a mobile device with Android/iOS operating system,
  • be able to use a phone,
  • ≥ 40 years old,
  • have no communication barriers,
  • mild (Stage 1), moderate (Stage 2), severe (Stage 3), or very severe (Stage 4) stages according to the GOLD (2023) report.

You may not qualify if:

  • Those diagnosed with COPD less than 6 months ago,
  • Those receiving outpatient treatment,
  • Those hospitalized in the intensive care unit,
  • Those without internet access and a mobile device with Android/iOS operating system,
  • Those who do not have the ability to use a phone,
  • Those under 40 years of age,
  • Those with communication barriers,
  • Those who wish to withdraw from the research/withdraw from participation during the research process,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nursing, Faculty of Health Sciences, Canakkale Onsekiz Mart University

Çanakkale, 17100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Telenursing

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NursingProfessional PracticeOrganization and AdministrationHealth Services AdministrationTelemedicineDelivery of Health CarePatient Care Management

Study Officials

  • SEVDA ATEŞ, Associate Professor

    Çanakkale Onsekiz Mart University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SEVDA ATEŞ, Associate Professor

CONTACT

SEVDA TUREN, Associate Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: experimental design with pre-test and post-test control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 5, 2026

First Posted

March 10, 2026

Study Start

March 4, 2026

Primary Completion

March 4, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

The datasets generated and/or analysed during the current study are not publicly available due privacy reasons but are available from the corresponding author on reasonable request.

Locations