NCT04723329

Brief Summary

The aim of this thesis is; The aim of this study is to examine the effect of web-based training based on transtheoretic model on exercise behavior in patients with coronary artery disease. The research is a randomized controlled trial. 114 patient who meet the conditions for research will be included in the study. In collecting data, the Patient Information Form, Exercise Change Phase Short Question Form, Exercise Change Processes Scale, Exercise Decision Making Scale and Exercise Self-Efficacy Scale developed by the researcher will be used.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 13, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 13, 2021

Last Update Submit

January 22, 2021

Conditions

Keywords

Exerciseweb-based educationPatients

Outcome Measures

Primary Outcomes (4)

  • Exercise Change Stage

    Exercise Change Stage Short Question Form is an 5 item scale. 1=Exercising regularly for more than 6 months, 2=Exercising regularly for less than 6 months, 3=Does not exercise but intends to do it within 30 days, 4=Does not exercising but intends to start within 6 months, 5=Does not exercise and does not intend to start within 6 months

    up to 6 months

  • Exercise Change Processes Scale

    Change Processes Scale is an 28 item scale.Individuals in the scale do not agree with each statement using a 5-point Likert scale. is determined. Each individual in scale how much to exercise in the condition stated in item he often does a It is determined by the grading score. From the interviewee, the items of this scale by reading "1 = never" for each item, "2 = rarely", "3 = occasionally", "4 = often", "5 very often" the most suitable for him He is asked to select and mark the one. Scale, item points of all subscales score obtained from averages It is evaluated according to the average.There are cognitive and behavioral processes that facilitate change in the Exercise Change Processes Scale. The overall Cronbach's alpha coefficient of the scale is 0.95, and it was determined as 0.91 for cognitive processes with sub-dimensions and 0.93 for behavioral processes.

    up to 6 months

  • Exercise Decision-Making Balance

    Change Processes Scale is an 10 item scale. Total score of the scale, the perceived benefit of exercising is total of the total score of perceived damage It is obtained by subtraction. Your result negative (-), in decision-making balance the perceived harms of exercise dominant, positive (+), decision exercising in a giving balance a sign that the perceived benefits are dominant does. The highest score that can be obtained from the scale 25 is the lowest score is 5.

    up to 6 months

  • Exercise Self-Efficacy Scale

    Self-Efficacy Scale is an 6 item scale.From scale the highest score an individual can get is 30, low score is 6. In the evaluation of the scale; The higher the item score average, the higher the individual's selfishness.

    up to 6 months

Study Arms (2)

web-based education group

EXPERIMENTAL

Patients will be given a username and password to access the website. The change stage of the patients will be determined by the researcher with the Exercise Change Phase Short Question Form, and it will be ensured that they reach the educational content prepared according to the transtheoretic model. Motivating interviews will be provided to the patients to receive training on the website by contacting them one-on-one. In the following 1st and 3rd months, patients will be contacted individually again to confirm whether they follow the website, and they will be asked to fill in the scales on the website by providing consultancy on the issues they need. In the 6th month, the final test data will be obtained from the website using the same data collection forms.

Behavioral: Web-based exercise training based on the transtheoretic model

Control Group

NO INTERVENTION

In the first interview, the patients in the control group will be collected data and contact information will be obtained using the Patient Information Form, Exercise Change Phase Short Question Form, Change Processes Scale, Decision Making Balance Scale and Self-Efficacy Scale. Later, patients will be given their username and password so that they can log into the website where the scales are located in order to apply the final test. No intervention will be applied to the patients in the control group. At the end of the 6th month, the same scales will be applied on the website as a final test. At the end of the study, it is aimed to gain exercise behavior to the patients in the control group.

Interventions

Motivating interviews will be provided to the patients to receive training on the website by contacting them one-on-one. In the following 1st and 3rd months, patients will be contacted individually again to confirm whether they follow the website, and they will be asked to fill in the scales on the website by providing consultancy on the issues they need. In the 6th month, the final test data will be obtained from the website using the same data collection forms.

web-based education group

Eligibility Criteria

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

You may qualify if:

  • Being literate
  • Having internet access and using it comfortably, Independent in daily life activities

You may not qualify if:

  • Have any physical and psychological problems that prevent exercising
  • Those who do not intend to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep UNVER

Malatya, 44100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

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

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 25, 2021

Study Start

February 1, 2021

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

January 25, 2021

Record last verified: 2021-01

Locations