NCT05484843

Brief Summary

There are many methods that nurses use while providing care education to individuals. Tele-nursing, which is one of the current methods, is an innovative approach, but it is a useful method in meeting the post-discharge home care needs of patients who are dependent or partially dependent on others and who live in areas far from health care institutions. In today's health care delivery system, it is of great importance to develop a tele-nursing-based care approach by making effective infrastructure studies related to tele-nursing services. Although a limited number of studies have been conducted on different patient groups regarding the tele-nursing method in Turkey, no study has been found that determines the effect of tele-nursing education on patients' quality of life and self-care power in stroke patients. In this respect, it is thought that it is important to conduct studies that will examine the effects of tele-nursing on patients who need long-term care such as stroke at the national level. The aim of this study is to find out the effects of telenursing training based on self-care theory which was given to patients diagnosed with stroke on quality of life and self-care agency.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Apr 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

1.1 years

First QC Date

July 28, 2022

Last Update Submit

July 30, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Changing Quality of Life Scale

    Stroke Specific Quality of Life Scale The original scale, which consists of 49 items, consists of 12 domains that evaluate mobility, energy, upper extremity function, self-care, occupation/productivity, temperament, social role, family role, vision, language, thinking, and personality traits. The stroke-specific quality of life scale is a 5-point Likert type and can be scored from 1 to 5 points according to the statements given. The average score that can be obtained from each sub-dimension is between 1 point and 5 points. The score obtained from the scale; It is calculated by dividing the sum of the points obtained from each item by the number of items. The sub-dimension mean score is calculated by dividing the total sub-dimension score by the number of sub-dimension items. A high mean score of the scale indicates that the quality of life also improves positively.

    pre-training

  • Changing Self-Care Power

    Examination of Self-Care Agency Scale The Self-Care Power Scale consists of 35 items to determine the self-care skills of individuals and is shaped on 4 basic characteristics. These; Among the situations, active and passive response, motivation, knowledge of health practices, individuals' own feelings and values. The Self-Care Strength Scale is a 5-point Likert type and can be scored from 0 to 4 according to the statements given. 8 of the questions (3,6,9,13,19,22,26,31) are evaluated in reverse. The highest 140 points can be obtained from the scale. It is accepted that as the score obtained from the scale increases in line with the answers of the individuals, the level of self-care power also increases.

    pre-training

  • Daily Life Activities

    Katz Daily Life Activities Scale Katz Daily Living Activities Scale consists of 6 questions including information about bathing, dressing, toilet, movement, excretion, feeding activities. Evaluation is made by giving 3 points if the individual performs the activities of daily living independently, 2 points if he/she does it with assistance, and 1 point if he/she cannot do it at all. Katz Activities of Daily Living Scale; 0-6 points as "dependent", 7-12 points as "semi-dependent", 13-18 points as "independent".

    pre-training

Secondary Outcomes (2)

  • Changing Quality of Life

    post-training (3 months later)

  • Changing Self-Care Power

    post-training (3 months later)

Study Arms (2)

Stroke patients_intervention group

EXPERIMENTAL

Inclusion criteria for the study: * Being over 18 years old * Being of all genders, male and female * Being able to communicate in Turkish * Having had a hemorrhagic or ischemic stroke * Not more than one month after the stroke event. * Being oriented to person, place and time * Not being aphasic * Having a score of 21 or above on the Montreal Cognitive Assessment Scale (MOBİD) * Not having serious vision and hearing problems * Not having a psychiatric history * Being open to communication and cooperation * To be willing and voluntarily to participate in the study.

Behavioral: telenursing training based on self-care theoryBehavioral: just observation

stroke patients_control group

EXPERIMENTAL

Inclusion criteria for the study: * Being over 18 years old * Being of all genders, male and female * Being able to communicate in Turkish * Having had a hemorrhagic or ischemic stroke * Not more than one month after the stroke event. * Being oriented to person, place and time * Not being aphasic * Having a score of 21 or above on the Montreal Cognitive Assessment Scale (MOBİD) * Not having serious vision and hearing problems * Not having a psychiatric history * Being open to communication and cooperation * To be willing and voluntarily to participate in the study.

Behavioral: telenursing training based on self-care theoryBehavioral: just observation

Interventions

* A training guide based on the self-care theory specific to individuals diagnosed with stroke was prepared. * Identification of the study/control group (randomization) * Patients were informed and consents were obtained. * Sample suitability was evaluated in line with the cognitive levels and inclusion criteria of patients diagnosed with stroke. * All patients included in the sample group were pre-tested before discharge. * Training was offered for the study group patients in line with the guide prepared based on self-care theory. * Tele-nursing training was applied to the study group patients. * Control group patients were followed up * Post-tests were administered at the end of the 12-week period * The training of the control group patients was completed * Your data has been evaluated

Stroke patients_intervention groupstroke patients_control group

For 3 months, patients were observed without intervention. The standard discharge training of the clinic was given.

Stroke patients_intervention groupstroke patients_control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 18 years old
  • Being of all genders, male and female
  • Being able to communicate in Turkish
  • Having had a hemorrhagic or ischemic stroke
  • Not more than one month after the stroke event.
  • Being oriented to person, place and time
  • Not being aphasic
  • Having a score of 21 or above on the Montreal Cognitive Assessment Scale (MOBİD)
  • Not having serious vision and hearing problems
  • Not having a psychiatric history
  • Being open to communication and cooperation
  • To be willing and voluntarily to participate in the study.

You may not qualify if:

  • Being under the age of 18
  • Lack of orientation to person, place and time
  • Being aphasic
  • Having a score below 21 on the Montreal Cognitive Assessment Scale (MOCA)
  • Not being willing and voluntarily to participate in the study
  • Having developed an acute condition that may affect the patient's prognosis during the data collection process.
  • To have had a secondary stroke or to be exitus during the follow-up period.
  • Being under the age of 18,
  • Not being oriented to person, place and time,
  • Being aphasic,
  • Having a score below 21 on the Montreal Cognitive Assessment Scale (MOBİD),
  • Not being willing or voluntarily to participate in the study,
  • Having developed an acute condition that may affect the patient's prognosis during the data collection process,
  • To have had a secondary stroke or to be exitus during the follow-up period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

Related Publications (3)

  • Spassova L, Vittore D, Droste DW, Rosch N. Randomised controlled trial to evaluate the efficacy and usability of a computerised phone-based lifestyle coaching system for primary and secondary prevention of stroke. BMC Neurol. 2016 Feb 9;16:22. doi: 10.1186/s12883-016-0540-4.

  • Lin S, Xiao LD, Chamberlain D, Ullah S, Wang Y, Shen Y, Chen Z, Wu M. Nurse-led health coaching programme to improve hospital-to-home transitional care for stroke survivors: A randomised controlled trial. Patient Educ Couns. 2022 Apr;105(4):917-925. doi: 10.1016/j.pec.2021.07.020. Epub 2021 Jul 14.

  • Kalav S, Bektas H, Unal A. Effects of Chronic Care Model-based interventions on self-management, quality of life and patient satisfaction in patients with ischemic stroke: A single-blinded randomized controlled trial. Jpn J Nurs Sci. 2022 Jan;19(1):e12441. doi: 10.1111/jjns.12441. Epub 2021 Jul 15.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study was in the experimental type and was conducted as a longitudinal, randomized controlled study according to the pretest-posttest trial model.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cansev BAL, Phd. Candidate, Principle Investigator, Ondokuz Mayıs University

Study Record Dates

First Submitted

July 28, 2022

First Posted

August 2, 2022

Study Start

April 10, 2021

Primary Completion

May 10, 2022

Study Completion

July 1, 2022

Last Updated

August 2, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Other researchers may view the study once it is published.

Locations