MotivationMotivationNCT05100524
Motivational Interview for Daily Living Activities in Elderly People Undergoing Total Knee Replacement
A study testing Motivational interview and Ongoing treatment in people with Motivation and Behavior, Health, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: In this study, it was aimed to examine the effect of motivational interview on daily living activities on physical adaptation and quality of life in elderly people who underwent total knee replacement.it was aimed to examine the effect of motivational interview on daily living activities on physical… Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Motivation, Behavior, Health, Nursing Caries
- What is being tested?
- Motivational interview and Ongoing treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2020to 26 Jul 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Those aged 65 and over,
- Having total knee replacement,
- The non-spiritual system (the peasant of the sick),
- A person who can read and write can cope at a level that prevents conversation,
- First time system add-on,
- They are viewed as agreeing to participate in the research.
Who cannot join
- Neurological (such as dementia) and psychiatric (such as schizophrenia) medical diagnoses that affect cognitive status
- Patients who did not participate in the motivational interviews and who wanted to leave the study were determined.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Motivational Interview for Daily Living Activities on Physical Adjustment and Quality of Life in Elderly People Who Have Had Total Knee Replacement
Purpose: In this study, it was aimed to examine the effect of motivational interview on daily living activities on physical adaptation and quality of life in elderly people who underwent total knee replacement.it was aimed to examine the effect of motivational interview on daily living activities on physical adaptation and quality of life in elderly people who underwent total knee replacement.
Design: The research was planned as a pretest, posttest, randomized controlled study in order to determine the effect of the motivational interviews on the life quality and physical activity of old patients.
Read more
H1: After total knee replacement, the target for daily living activities is higher than the patients who applied the hand and those who did not.
H2: Patients with targeted daily living activities with total knee replacement begin to get used to it and begin earlier than those who do not.
- Conditions
- Motivation, Behavior, Health, Nursing Caries, Nurse's Role
- Being tested
- Motivational interview, Ongoing treatment
- Keywords
- motıvatıonal ıntervıew, total knee prosthesıs, old age, quality of life, physical compatibility
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewOther
The motivational interviewing technique is a client-focused, directive form of counseling to create behavior change. Its main goal is to discover and solve ambivalence. This method is especially useful for people who are reluctant or ambivalent to change.
Ongoing treatmentOther
Patients with total knee replacement receive standard nurse care. Treatment is applied. He does his own exercises at home.
| Study group | Role | What they receive |
|---|---|---|
| Motivational interview | Experimental | 8 motivational interviews were conducted with the intervention group. Receives: Other: Motivational interview |
| Control Group | Active comparator | No application was made to increase physical compliance and improve quality of life. Receives: Other: Ongoing treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The SF-36 Quality of Life Scale
The SF-36 Quality of Life Scale consists of 8 subgroups and 36 questions. The fourth and fifth questions of the SF-36 scale are yes/no, the other questions are likert type (3, 5 and 6). Items 1, 6, 7, 8, 9a, 9d, 9e, 9h, 11b, 11d in the scale are calculated by reversing them. The physical and mental summary value of the scale is obtained by adding the weighted scores of the questions containing the sub-scales of the SF-36 quality of life scale. There is no total score. The scores obtained range from zero to one hundred. Zero indicates poor health and 100 indicates good health.
Measured: For 3 months
Functional Evaluation Form
The Functional Evaluation Form consists of 8 sections, including maximum walking distance, use of walking aids, getting up from a chair, climbing stairs, working status, daily tasks, transportation and lower extremity care, and each section is self-contained (first four sections are out of 15 points, the remaining four sections are out of 10 points). The highest total score is 100. An increase in the score indicates functional improvement.
Measured: For3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start2 Sep 2020
- Primary completion25 May 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MotivationStudies 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
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, Gizem KUBAT BAKIR, Maltepe University
- Investigators
- GİZEM KUBAT BAKIR, Principal investigator, GİZEM KUBAT BAKIR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100524
- Sponsor's protocol ID
- 0050
- Acronym
- Motivation
- Status last verified
- Dec 2022
- First submitted
- 13 Sep 2021
- Last updated
- 29 Dec 2022
- Results posted
- 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 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interview for Daily Living Activities on Physical Adjustment and Quality of Life in Elderly People Who Have Had Total Knee Replacement
- ClinicalTrials.gov ID
- NCT05100524
- Acronym / sponsor ID
- Motivation / 0050
- Conditions
- Motivation, Behavior, Health, Nursing Caries, Nurse's Role
- Keywords
- motıvatıonal ıntervıew, total knee prosthesıs, old age, quality of life, physical compatibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 29 Oct 2021 (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.
Purpose: In this study, it was aimed to examine the effect of motivational interview on daily living activities on physical adaptation and quality of life in elderly people who underwent total knee replacement.it was aimed to examine the effect of motivational interview on daily living activities on physical adaptation and quality of life in elderly people who underwent total knee replacement.
Design: The research was planned as a pretest, posttest, randomized controlled study in order to determine the effect of the motivational interviews on the life quality and physical activity of old patients.
H1: After total knee replacement, the target for daily living activities is higher than the patients who applied the hand and those who did not.
H2: Patients with targeted daily living activities with total knee replacement begin to get used to it and begin earlier than those who do not.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Motivational interview | Experimental | Other: Motivational interview8 motivational interviews were conducted with the intervention group. |
| Control Group | Active comparator | Other: Ongoing treatmentNo application was made to increase physical compliance and improve quality of life. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Those aged 65 and over,
- Having total knee replacement,
- The non-spiritual system (the peasant of the sick),
- A person who can read and write can cope at a level that prevents conversation,
- First time system add-on,
Key exclusion criteria (2 listed)
- Neurological (such as dementia) and psychiatric (such as schizophrenia) medical diagnoses that affect cognitive status
- Patients who did not participate in the motivational interviews and who wanted to leave the study were determined.
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 |
|---|---|---|
| Motivational interviewThe motivational interviewing technique is a client-focused, directive form of counseling to create behavior change. Its main goal is to discover and solve ambivalence. This method is especially useful for people who are reluctant or ambivalent to change. | Other | Motivational interview |
| Ongoing treatmentPatients with total knee replacement receive standard nurse care. Treatment is applied. He does his own exercises at home. | Other | Control Group |
Primary outcome
The SF-36 Quality of Life Scale
Time frame: For 3 months
The SF-36 Quality of Life Scale consists of 8 subgroups and 36 questions. The fourth and fifth questions of the SF-36 scale are yes/no, the other questions are likert type (3, 5 and 6). Items 1, 6, 7, 8, 9a, 9d, 9e, 9h, 11b, 11d in the scale are calculated by reversing them. The physical and mental summary value of the scale is obtained by adding the weighted scores of the questions containing the sub-scales of the SF-36 quality of life scale. There is no total score. The scores obtained range from zero to one hundred. Zero indicates poor health and 100 indicates good health.
Functional Evaluation Form
Time frame: For3 months
The Functional Evaluation Form consists of 8 sections, including maximum walking distance, use of walking aids, getting up from a chair, climbing stairs, working status, daily tasks, transportation and lower extremity care, and each section is self-contained (first four sections are out of 15 points, the remaining four sections are out of 10 points). The highest total score is 100. An increase in the score indicates functional improvement.
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 29 Dec 2022.
- Motivational interviewing to increase physical activity in long-term cancer survivors: a randomized controlled trialLink provided by the sponsor.
- Effectiveness of a motivational interviewing intervention on weight loss, physical activity and cardiovascular disease risk factors: a randomised controlled trial with a 12-month post-intervention follow-upLink provided by the sponsor.
- 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.
GİZEM KUBAT BAKIR principal investigator
GİZEM KUBAT BAKIR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interview and Ongoing treatment in people with Motivation and Behavior, Health, run by Maltepe University 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 6 inclusion and 2 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 29 Dec 2022. 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?
The SF-36 Quality of Life Scale (time frame: For 3 months). The study lists 2 primary outcomes in all. 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 29 Dec 2022.