- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06346964
Self-Care Management in Older Adults
March 29, 2024 updated by: Ayşegül Akca, Ankara Yildirim Beyazıt University
Strengthening Participation in Social Life Through Rational Drug Use and Disease Self-Care Management in Older Adults
Self-management of chronic diseases requires the ability to manage the symptoms, treatment, and lifestyle changes inherent in living with a chronic disease.
Rational drug use by older adults is of particular importance.
Mobile applications are being developed to facilitate the compliance of older adults with chronic diseases with medication treatment and to increase their disease self-management skills.
The research was planned to strengthen participation in social life through rational drug use and disease self-care management in older adults with chronic diseases.
The research will be conducted in a parallel group randomized controlled manner.
In the research, a mobile application will be developed for the use of older adults.
Older adults will be asked to use the mobile application for at least 6 months, and the scales will be re-administered face to face or online in the 3rd and 6th months of the intervention.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
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
-
-
Çubuk/Turkey
-
Ankara, Çubuk/Turkey, Turkey, 06760
- Ankara Yıldırım Beyazıt University
-
-
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
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being in the 60-79 age group,
- Having a chronic disease that requires constant monitoring and treatment
- Using at least one medication for your disease regularly
- Having smart phone usage skills
Exclusion Criteria:
- Having vision and hearing problems
- Being 80 or older
- Having a neuro-psychiatric disease
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 |
---|---|
No Intervention: Control
No intervention has been made.
|
|
Experimental: mobile application
Older adults will be asked to use the mobile application for at least 6 months, and the scales will be re-administered face to face or online in the 3rd and 6th months of the intervention.
|
The mobile application prepared for rational drug use and chronic disease self-management, suitable for use by older adults, will be required to be used for 6 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participation in social life (Social Inclusion Scale)
Time Frame: baseline
|
It was developed in 2009 by Secker et al. to measure an individual's relationship with other people.
A validity and reliability study of the Turkish version of the scale was conducted.
4 items were removed from the original 22-item scale and the final version consisted of 18 items.
The lowest and highest that can be taken from the scale are 18 and 72.
A higher score from the scale indicates more socialization.
|
baseline
|
Participation in social life (Social Inclusion Scale)
Time Frame: within first week
|
It was developed in 2009 by Secker et al. to measure an individual's relationship with other people.
A validity and reliability study of the Turkish version of the scale was conducted.
4 items were removed from the original 22-item scale and the final version consisted of 18 items.
The lowest and highest that can be taken from the scale are 18 and 72.
A higher score from the scale indicates more socialization.
|
within first week
|
Participation in social life (Social Inclusion Scale)
Time Frame: twelfth week
|
It was developed in 2009 by Secker et al. to measure an individual's relationship with other people.
A validity and reliability study of the Turkish version of the scale was conducted.
4 items were removed from the original 22-item scale and the final version consisted of 18 items.
The lowest and highest that can be taken from the scale are 18 and 72.
A higher score from the scale indicates more socialization.
|
twelfth week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Estimated)
April 22, 2024
Primary Completion (Estimated)
April 22, 2025
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
March 29, 2024
First Submitted That Met QC Criteria
March 29, 2024
First Posted (Actual)
April 4, 2024
Study Record Updates
Last Update Posted (Actual)
April 4, 2024
Last Update Submitted That Met QC Criteria
March 29, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2024-341
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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