NCT06217718

Brief Summary

The aim of this study is to evaluate the effect of telenursing interventions based on the empowerment model in empowering patients with COPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

January 7, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

June 25, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2024

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

January 7, 2024

Last Update Submit

March 9, 2025

Conditions

Keywords

telenursingempowermentPulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • COPD Empowerment Scale

    A 31-item scale that evaluates the impact of interventions on individuals with COPD.

    Pre-test, Post-test (3rd month), Follow-up Test (6th month)

Secondary Outcomes (7)

  • Lung Function Test

    Pre-test, Post-test (3rd month), Follow-up Test (6th month)

  • COPD Assesment Test

    Pre-test, Post-test (3rd month), Follow-up Test (6th month)

  • Number of hospital admissions due to COPD exacerbation

    Pre-test, Post-test (3rd month), Follow-up Test (6th month)

  • Number of hospitalizations due to COPD exacerbation

    Pre-test, Post-test (3rd month), Follow-up Test (6th month)

  • Modified Barthel Index

    Pre-test, Post-test (3rd month), Follow-up Test (6th month)

  • +2 more secondary outcomes

Study Arms (2)

Telenursing Interventions Group

EXPERIMENTAL

Participants in this group will receive five hours of face-to-face empowerment training. After the training, the experimental group will be monitored remotely by the researcher nurse via tele-nursing interventions for 12 weeks. Participants will be given a pulse oximeter, symptom diary, action plan, oxygen saturation-pulse monitoring chart. Participants will be asked to measure their oxygen saturation and pulse once a day for 12 weeks and record it on the chart. Participants will also be asked to record their complaints in their symptom diary. Participants will be called by the researcher every two weeks (on Thursdays) and informative and reminding text messages prepared specifically for the disease will be sent to the participants three times a week for 12 weeks. Participants will be able to reach the researchers by phone whenever they need.

Other: Telenursing Interventions

No Intervention Group

NO INTERVENTION

Participants in this group will be given a pulse oximeter, symptom diary, action plan, oxygen saturation-pulse monitoring chart. No intervention will be taken.

Interventions

Patient follow-up with phone calls and text messages

Telenursing Interventions Group

Eligibility Criteria

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

You may qualify if:

  • Having a confirmed COPD diagnosis for at least one year
  • being literate,
  • Having the cognitive and mental competence to answer questions,
  • Being able to use a mobile phone,
  • Disease symptoms are at a level that does not interfere with communication,
  • Being in COPD Stage 2 and Stage 3 according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD: Global Initiative for Chronic Obstructive Lung Disease) criteria (30% ≤ FEV1 \<80% (of expected)),

You may not qualify if:

  • The disease is in the acute exacerbation period,
  • Dyspnea is at a level that prevents cooperation,
  • Having sensory loss regarding vision, hearing and speech,
  • Refusal to sign informed consent forms
  • It is the refusal of the research to complete the data collection tools.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital

Istanbul, Maltepe, 34844, Turkey (Türkiye)

Location

Related Publications (1)

  • Aksoy Z, Erol S, Oruc O. Effects of empowerment model-based telenursing interventions on empowerment in individuals with COPD. BMC Nurs. 2025 Dec 19;25(1):52. doi: 10.1186/s12912-025-04225-z.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmpowermentPatient Participation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSocial BehaviorBehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Zahide Aksoy, MSc

    Marmara University

    PRINCIPAL INVESTIGATOR
  • Saime Erol, Ph.D

    Marmara University

    STUDY DIRECTOR
  • Özlem Oruç, M.D

    Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
In order to prevent selection bias in the study, the assignment to the experimental and control groups will be made on a computer by a person who is unfamiliar with the research process. Individuals included in the study will not be told whether they are in the experimental or control group. The analysis of the data will be done by a statistics expert who is outside the research process.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two groups with experimental and control groups
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 7, 2024

First Posted

January 22, 2024

Study Start

June 25, 2024

Primary Completion

August 25, 2024

Study Completion

November 25, 2024

Last Updated

March 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations