NCT06298175

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

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 15, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2021

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
Last Updated

March 7, 2024

Status Verified

February 1, 2024

Enrollment Period

Same day

First QC Date

February 22, 2024

Last Update Submit

March 6, 2024

Conditions

Keywords

Self-ManagementChronic ConditionsYoung Adults

Outcome Measures

Primary Outcomes (1)

  • 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).

    pre-treatment and post-treatment up to 8-weeks

Secondary Outcomes (2)

  • Cognitive Emotion Regulation Questionnaire (CERQ)

    pre-treatment and post-treatment up to 8-weeks

  • The Occupational Balance Questionnaire (OBQ)

    pre-treatment and post-treatment up to 8-weeks

Study Arms (2)

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.

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.

Behavioral: Self management training

Interventions

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

Control GroupIntervention Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • having no communication barriers
  • having a chronic disease such as asthma, diabetes, heart disease, or hypertension

You may not qualify if:

  • being under 35 years old
  • undergoing concurrent psychological treatment/therapy
  • having Covid-19
  • requiring treatment for other diseases during the training process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saglik Bilimleri Universitesi

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Esma Ozkan

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Pre-post test, randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

February 22, 2024

First Posted

March 7, 2024

Study Start

April 15, 2021

Primary Completion

April 15, 2021

Study Completion

August 15, 2021

Last Updated

March 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations