- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06298175
Self-Management Training With Online Intervention Process for Young Adults With Chronic Conditions
March 6, 2024 updated by: Esma Ozkan, Saglik Bilimleri Universitesi
Self-Management Training With Online Intervention Process for Young Adults With Chronic Conditions: Effects on Self-Management, Emotion Regulation, and Occupational Balance: A Randomized Controlled Study
The study was conducted from 15th April 2021 to 15th August 2021.
It employed a pretest-posttest design with control and training groups.
In this study, a pretest-posttest design including control and training groups was used.
Pre-assessments were taken from young adults who reported that they wanted to participate in the study via social media accounts and e-mail and who met the study criteria, and two groups were formed by the simple randomization method.
The study group received 8 weeks of self-management training.
The control group was informed about self-management for 1 week.
Final evaluations were conducted for both groups after eight weeks.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Pre-assessments were taken from young adults who reported that they wanted to participate in the study via social media accounts and e-mail and who met the study criteria, and two groups were formed by simple randomization method.
The study group received 8 weeks of self-management training.
The control group was informed about self-management for 1 week.
Final evaluations were conducted for both groups after eight weeks.
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey
- Saglik Bilimleri Universitesi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- having no communication barriers
- having a chronic disease such as asthma, diabetes, heart disease, or hypertension
Exclusion Criteria:
- being under 35 years old
- undergoing concurrent psychological treatment/therapy
- having Covid-19
- requiring treatment for other diseases during the training process
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
The study group received 8 weeks of self-management training.
Reflections, prepared using Power Point, were used in all sessions.
The study employed various methods, including the question-answer and audio-visual methods, as well as performance feedback when necessary during the sessions.
Final evaluations were conducted for both groups after eight weeks.
|
The self-management training programme for the study group consisted of eight sessions.
Each session lasted between 40 and 50 minutes and followed a structured format: a 5-minute introduction, a 5-minute summary of the previous session, and a 30-40 minute presentation on the session's topic.
Training plan on cognition, emotion regulation and self-management was implemented
|
Active Comparator: Control Group
The control group was informed about self-management for 1 week.
General information was given about approaches to improving self-management.
Final evaluations were conducted for both groups after eight weeks.
|
The self-management training programme for the study group consisted of eight sessions.
Each session lasted between 40 and 50 minutes and followed a structured format: a 5-minute introduction, a 5-minute summary of the previous session, and a 30-40 minute presentation on the session's topic.
Training plan on cognition, emotion regulation and self-management was implemented
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-Control Self-Management Scale (SCMS)
Time Frame: pre-treatment and post-treatment up to 8-weeks
|
The Self-Control and Self-Management Scale consists of three subscales: self-monitoring, self-evaluation and self-reinforcement.
It is a 6-point Likert-type scale consisting of 16 items (0= Does not define me at all, 5= Defines me completely).
|
pre-treatment and post-treatment up to 8-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive Emotion Regulation Questionnaire (CERQ)
Time Frame: pre-treatment and post-treatment up to 8-weeks
|
The five-point Likert-type scale (1 = not at all suitable for me, 2 = somewhat suitable for me, 3 = partially suitable for me, 4 = very suitable for me, 5 = completely suitable for me) consists of a total of 36 items.
It consists of nine sub-dimensions: self-blame, acceptance, rumination, positive refocusing, refocus on planning, positive reappraisal, putting into perspective, catastrophizing, and other-blame.
|
pre-treatment and post-treatment up to 8-weeks
|
The Occupational Balance Questionnaire (OBQ)
Time Frame: pre-treatment and post-treatment up to 8-weeks
|
In 2019, Günal et al. conducted a validity and reliability study of the 11-item revised version of the questionnaire in Turkish.
The scale consists of four response categories (strongly disagree, disagree, agree, strongly agree), with each item being assigned a value between 0 and 3 points.
The sum of the individual items results in a score between 0 and 33.
|
pre-treatment and post-treatment up to 8-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Esma Ozkan, Saglik Bilimleri Universitesi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2021
Primary Completion (Actual)
April 15, 2021
Study Completion (Actual)
August 15, 2021
Study Registration Dates
First Submitted
February 22, 2024
First Submitted That Met QC Criteria
March 6, 2024
First Posted (Actual)
March 7, 2024
Study Record Updates
Last Update Posted (Actual)
March 7, 2024
Last Update Submitted That Met QC Criteria
March 6, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-157
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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