- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07526779
Motivational Interviewing on Loneliness Level, Activities of Daily Living, and Quality of Life in Elderly (Experimental)
The Effect of Motivational Interviewing on Loneliness Level, Activities of Daily Living, and Quality of Life in Elderly Individuals Living Alone: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a randomized controlled experimental study examining the effect of motivational interviewing on individuals aged 65 and older who live alone. It will be conducted at a public hospital between April and December 2026.
A total of 60 participants (30 in the experimental group, 30 in the control group) will be randomly assigned to groups. The experimental group will receive a total of 4 sessions of motivational interviewing over 4 weeks, with one session per week; each session will last approximately 30-40 minutes. The control group will receive no intervention.
In the study, loneliness levels, daily living activities, and quality of life will be assessed using pre- and post-tests. The data will be analyzed statistically to determine the effect of motivational interviewing.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aysun BAYRAM Associate Professor, PhD
- Phone Number: +90 462 377 8866
- Email: aysunbayram@ktu.edu.tr
Study Locations
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Trabzon, Turkey (Türkiye)
- Karadeniz Technical University
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Contact:
- Aysun BAYRAM Faculty of Health Sciences, Karadeniz Technical University, PhD
- Phone Number: +90 462 377 8862
- Email: aysunbayram@ktu.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- being 65 years of age or older,
- living alone,
- volunteering to participate in the study,
- possessing sufficient cognitive ability to communicate,
- being able to communicate in Turkish.
Exclusion Criteria:
- having a diagnosis of severe cognitive impairment or dementia,
- having significant hearing or communication difficulties,
- being unable to participate regularly in the research process
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental: Group 1:Motivational Interviewing
The experimental group will undergo a total of four motivational interviews over a four-week period, with one session per week; each session will last approximately 30-40 minutes.
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Motivational interviewing is a client-centered, empathetic, and supportive communication approach aimed at eliciting and strengthening an individual's intrinsic motivation for behavioral change.
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No Intervention: Control Group: Routine Skills Training Group
No intervention will be performed on the control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
UCLA Loneliness Scale-6-Item Short Form
Time Frame: Time Frame: before the intervention, immediately after fourth sessions of the intervention
|
This form is a brief and practical measure used to assess the level of loneliness perceived by individuals.
The UCLA Loneliness Scale - 6-Item Short Form is a 4-point Likert-type scale.
The items on the scale are rated as "never," "rarely," "sometimes," and "often."
The total score that can be obtained from the scale ranges from 6 to 24.
A high score on the scale indicates a high level of loneliness in the individual.
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Time Frame: before the intervention, immediately after fourth sessions of the intervention
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Lawton Instrumental Activities of Daily Living Scale
Time Frame: Time Frame: before the intervention, immediately after fourth sessions of the intervention
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Developed to assess older adults' ability to perform more complex activities in daily life.
The scale consists of a total of 8 items and assesses instrumental activities of daily living such as using the telephone, shopping, preparing meals, performing household chores, doing laundry, using transportation, taking medications regularly, and managing financial affairs.
Scale items are scored based on the individual's level of independence.
Each item is evaluated as 0 or 1 point.
The total score that can be obtained from the scale ranges from 0 to 8. A low score indicates that the individual is more dependent, while a high score indicates that the individual is more independent.
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Time Frame: before the intervention, immediately after fourth sessions of the intervention
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Quality of Life Scale for Older Adults
Time Frame: Time Frame: before the intervention, immediately after fourth sessions of the intervention
|
It was developed to assess the quality of life of older adults.
The original version of the scale consists of 19 items and has four subscales: control, autonomy, self-actualization, and pleasure.
Form 1 consists of 13 items and two subscales.
The items in the scale are scored on a 4-point Likert scale: "never (0)", "rarely (1)", "sometimes (2)", and "always (3)".
Items 1, 2, and 4 are reverse-coded.
A higher total score on the scale indicates that the individual has a high quality of life.
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Time Frame: before the intervention, immediately after fourth sessions of the intervention
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-KTU
- Aysun BAYRAM (Registry Identifier: Aysun BAYRAM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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