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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Self management training
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.
Behavioral: Self management training
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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