Chronic DiseaseNCT06298175
Self-Management Training With Online Intervention Process for Young Adults With Chronic Conditions
A study testing Self management training in people with Chronic Disease, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Self management training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2021to 15 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- having no communication barriers
- having a chronic disease such as asthma, diabetes, heart disease, or hypertension
Who cannot join
- being under 35 years old
- undergoing concurrent psychological treatment/therapy
- having Covid-19
- requiring treatment for other diseases during the training process
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Disease
- Being tested
- Self management training
- Keywords
- Self-Management, Chronic Conditions, Young Adults
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self management trainingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: Self management training |
| Control Group | Active comparator | 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. Receives: Behavioral: Self management training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Control Self-Management Scale (SCMS)
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).
Measured: pre-treatment and post-treatment up to 8-weeks
Secondary outcomes (2)
Cognitive Emotion Regulation Questionnaire (CERQ)
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.
Measured: pre-treatment and post-treatment up to 8-weeks
The Occupational Balance Questionnaire (OBQ)
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.
Measured: pre-treatment and post-treatment up to 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start15 Apr 2021
- Primary completion15 Apr 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pre-post test, randomized controlled study
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esma Ozkan, Saglik Bilimleri Universitesi
- Investigators
- Esma Ozkan, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298175
- Sponsor's protocol ID
- 2021-157
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06298175
- Acronym / sponsor ID
- 2021-157
- Conditions
- Chronic Disease
- Keywords
- Self-Management, Chronic Conditions, Young Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pre-post test, randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Self management trainingThe 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. |
| Control Group | Active comparator | Behavioral: Self management trainingThe 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- having no communication barriers
- having a chronic disease such as asthma, diabetes, heart disease, or hypertension
Key exclusion criteria (4 listed)
- being under 35 years old
- undergoing concurrent psychological treatment/therapy
- having Covid-19
- requiring treatment for other diseases during the training process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self management trainingThe 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 | Behavioural | Control Group, Intervention Group |
Primary outcome
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).
2 secondary outcomes
Cognitive Emotion Regulation Questionnaire (CERQ)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esma Ozkan principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self management training in people with Chronic Disease, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Control Self-Management Scale (SCMS) (time frame: pre-treatment and post-treatment up to 8-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.