Drug ComplianceMOTIVATIONNCT05676021
The Effect of Motivational Interviewing on the Adherence to Medication of Patients With COVID-19 Diagnosed at Home
A study testing motivational interview in people with Drug Compliance, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial summary
Summary Objective: The aim of this study is to determine the effect of health education supported by motivational interviewing on drug therapy compliance of patients with COVID-19 who are followed at home. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Compliance
- What is being tested?
- motivational interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2021to 20 Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who volunteered to participate in the study
- 18 years old and over,
- Able to read and write Turkish,
- Having a COVID-19 patient followed at home,
- Having the equipment to make video calls over the internet connection,
- Individuals with a drug compliance reporting scale score below 20 points
Who cannot join
- Contraindicated to use antiviral drug (Favipiravir) (liver failure, kidney failure, active chemotherapy treatment)
- Pregnant,
- Patients who were hospitalized for any reason during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Health Education Supported by Motivational Interviewing on the Adherence to Medication of Patients With COVID-19 Diagnosed at Home
Summary Objective: The aim of this study is to determine the effect of health education supported by motivational interviewing on drug therapy compliance of patients with COVID-19 who are followed at home.
Materials and Methods: 100 participants with a diagnosis of COVID-19 followed at home were divided into intervention (50) and control (50) groups by block randomization method. The data at the beginning of the study were obtained with the Introductory Information Form (16 questions). At the end of the study, the Medication Compliance Notification Scale and the level of satisfaction with medication (1 question) questionnaire were applied to the participants. The "Medicine Calendar" was used to track the drug use status of all participants. In the study, while the control group received standard COVID-19 drug therapy, in addition to the standard treatment to the intervention group; On the second day of the treatment, health education supplemented with motivational interviewing was conducted online.
Read more
Results: At the end of the study, it was found that the mean score of drug compliance (16.12±5.37) of the participants in the intervention group was higher than the mean score of the participants in the control group (9.96±5.62) (p<0.05). The mean score of drug compliance (16.12±5.37) of the participants in the intervention group at the end of the study was higher than the mean score at the beginning of the study (11.02±4.03) (p<0.05). The mean adherence score of the control group at the end of the study (9.96±5.62) was found to be lower than the mean score of adherence (11.40±4.93) at the beginning of the study (p<0.05). At the end of the study, when the participants in the intervention group were examined, it was seen that they were higher than the participants in the control group.
Conclusion: At the end of the study; The mean score of the intervention group's medication adherence scale increased significantly compared to the control group receiving standard medication; it was evaluated that this increase did not reach the desired level. This situation revealed how important the motivational interview-based health education given by nurses is in increasing drug compliance.
Read the detailed description
This study was designed as a randomized controlled trial. Between June 2021 and January 2022, it was carried out at the Gallipoli District Health Directorate, which is affiliated to the Çanakkale Provincial Health Directorate. The eligibility of patients for participation in the study was evaluated by the investigator. The sample size is in line with the results of the study of Çakmak and Kapucu in which they examined the effect of motivational interviewing on drug compliance in patients receiving oral chemotherapy; Assuming Type 1 error α=0.05, Type 2 error β=0.05, effect width f=0.6 ratios, 45 participants in each group in the G*Power program at 90% power and 95% confidence interval. counted as 90 participants. Taking into account possible losses, it was decided to add 10% reserve participants, and a total of 100 participants, 50 in each group, formed the sample size. Standard COVID-19 drug treatment procedures determined by the Ministry of Health are applied to COVID-19 positive patients by the District Health Directorate's filiation team and in the standard COVID-19 drug treatment procedure; On the day of the diagnosis of the disease, phone calls are made with the patients and the medical anamnesis of the patients is taken. On the same day, home visits are made to patients who do not have contraindication to antiviral drugs. In this visit, antiviral drugs are delivered to the patients by the filiation team, explaining how to use the drugs, and the "Favipiravir Usage Brochure" prepared by the Ministry of Health is given to the patients. Patients who were on the first day of treatment, who were determined to be COVID-19 positive, were asked if they volunteered to participate in the study, after a phone call by the principal investigator, followed by a brief briefing about the study, after the call of the filiation team. The condition of meeting the inclusion criteria of the study, excluding the level of drug compliance, of the patients who volunteered to participate in the study was examined. A face-to-face meeting was planned with participants who met the inclusion criteria on the same day. The patients who volunteered to participate in the study were given COVID-19 isolation precautions (overall, N95 and surgical mask, visor and gloves, social distance) and made a home visit at the scheduled time, "Voluntary Consent Forms" were given, and they were received in a sealed envelope to ensure contact isolation. During the face-to-face meeting, all patients were given the "Favipiravir Use Brochure" prepared by the Ministry of Health, explaining how to use the drug, and the "COVID-19 Drug Schedule" follow-up form, and how this form should be filled. Approximately antiviral drugs were delivered to the patient. However, the home visit was terminated by informing the patients that a video phone call would be made on the second day of the treatment.A video phone call was made with all participants on the second day of treatment. First of all, the participants were informed that they would be asked some questions about their personal information and medication, that there was no right or wrong answer option in the questions, and the participants were asked to share the most appropriate answer without hesitation. The questions and answer options in the introductory information form and the Drug Compliance Notification Scale were conveyed to the participant without guidance, and the answers of the participants were recorded. By ending the interview, data on the descriptive characteristics of the participants were collected, and the scores of the drug compliance reporting scale were evaluated. After the initial evaluation, patients with a mean drug adherence score above 20 (n=124) were excluded from the study. At this stage, randomization was achieved by assigning the participants to the intervention and control groups using the double-block randomization method according to the order of the case date.
- Conditions
- Drug Compliance
- Being tested
- motivational interview
- Keywords
- COVID-19, Medication Compliance, Motivational Interviewing, Health Education
- Medical subject headings
- Medication Adherence, COVID-19, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational interviewBehavioural
motivational interview-based health education
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | On the second day of the COVID-19 antiviral drug treatment, the participant assigned to the intervention group was interviewed face-to-face during the home visit by providing isolation measures. In the face-to-face meeting, the "COVID-19 Medication Use Brochure" was given and it was stated that the participants would be video-talked about the topics included in the booklet at an appropriate time on the same day, and time was planned. In the interview, it was decided to allow the participant to tell about their antiviral drug use, to learn about their feelings, thoughts and behaviors about drug use, to reveal their feelings of indecision and anxiety about treatment, to determine their resistance to drug use, to reveal their intrinsic motivation, to support them and to change their behavior. It was intended to take action to advance the cycle of change. Receives: Behavioral: motivational interview |
| control group | No intervention | After randomization, the participants in the control group continued to receive health care according to the standard COVID-19 drug treatment procedures determined by the Ministry of Health. No other intervention was performed apart from the participant standard COVID-19 drug therapy procedures in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
drug compliance reporting scale mean score
The Drug Compliance Reporting Scale is a Likert-type scale consisting of 5 items. The score to be taken from the scale is between 5 and 25. An increase in the scale score is interpreted as an increase in the level of drug compliance.
Measured: 5 days
Secondary outcomes (1)
increased drug compliance
The cut-off score of the drug compliance reporting scale is 20 points. At the end of the study, participants who score 20 points or more from the scale are considered to have a high level of drug compliance.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start15 Jun 2021
- Primary completion20 Dec 2021
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug ComplianceStudies 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
- randomised control trial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serpil Özdemir, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- burcu yılmaz, Principal investigator, Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676021
- Sponsor's protocol ID
- MOTIVATION
- Acronym
- MOTIVATION
- Status last verified
- Jan 2023
- First submitted
- 20 Dec 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Education Supported by Motivational Interviewing on the Adherence to Medication of Patients With COVID-19 Diagnosed at Home
- ClinicalTrials.gov ID
- NCT05676021
- Acronym / sponsor ID
- MOTIVATION / MOTIVATION
- Conditions
- Drug Compliance
- Keywords
- COVID-19, Medication Compliance, Motivational Interviewing, Health Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 9 Jan 2023 (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.
Summary Objective: The aim of this study is to determine the effect of health education supported by motivational interviewing on drug therapy compliance of patients with COVID-19 who are followed at home.
Materials and Methods: 100 participants with a diagnosis of COVID-19 followed at home were divided into intervention (50) and control (50) groups by block randomization method. The data at the beginning of the study were obtained with the Introductory Information Form (16 questions). At the end of the study, the Medication Compliance Notification Scale and the level of satisfaction with medication (1 question) questionnaire were applied to the participants. The "Medicine Calendar" was used to track the drug use status of all participants. In the study, while the control group received standard COVID-19 drug therapy, in addition to the standard treatment to the intervention group; On the second day of the treatment, health education supplemented with motivational interviewing was conducted online.
Results: At the end of the study, it was found that the mean score of drug compliance (16.12±5.37) of the participants in the intervention group was higher than the mean score of the participants in the control group (9.96±5.62) (p<0.05). The mean score of drug compliance (16.12±5.37) of the participants in the intervention group at the end of the study was higher than the mean score at the beginning of the study (11.02±4.03) (p<0.05). The mean adherence score of the control group at the end of the study (9.96±5.62) was found to be lower than the mean score of adherence (11.40±4.93) at the beginning of the study (p<0.05). At the end of the study, when the participants in the intervention group were examined, it was seen that they were higher than the participants in the control group.
Conclusion: At the end of the study; The mean score of the intervention group's medication adherence scale increased significantly compared to the control group receiving standard medication; it was evaluated that this increase did not reach the desired level. This situation revealed how important the motivational interview-based health education given by nurses is in increasing drug compliance.
Detailed description
This study was designed as a randomized controlled trial. Between June 2021 and January 2022, it was carried out at the Gallipoli District Health Directorate, which is affiliated to the Çanakkale Provincial Health Directorate. The eligibility of patients for participation in the study was evaluated by the investigator. The sample size is in line with the results of the study of Çakmak and Kapucu in which they examined the effect of motivational interviewing on drug compliance in patients receiving oral chemotherapy; Assuming Type 1 error α=0.05, Type 2 error β=0.05, effect width f=0.6 ratios, 45 participants in each group in the G*Power program at 90% power and 95% confidence interval. counted as 90 participants. Taking into account possible losses, it was decided to add 10% reserve participants, and a total of 100 participants, 50 in each group, formed the sample size. Standard COVID-19 drug treatment procedures determined by the Ministry of Health are applied to COVID-19 positive patients by the District Health Directorate's filiation team and in the standard COVID-19 drug treatment procedure; On the day of the diagnosis of the disease, phone calls are made with the patients and the medical anamnesis of the patients is taken. On the same day, home visits are made to patients who do not have contraindication to antiviral drugs. In this visit, antiviral drugs are delivered to the patients by the filiation team, explaining how to use the drugs, and the "Favipiravir Usage Brochure" prepared by the Ministry of Health is given to the patients. Patients who were on the first day of treatment, who were determined to be COVID-19 positive, were asked if they volunteered to participate in the study, after a phone call by the principal investigator, followed by a brief briefing about the study, after the call of the filiation team. The condition of meeting the inclusion criteria of the study, excluding the level of drug compliance, of the patients who volunteered to participate in the study was examined. A face-to-face meeting was planned with participants who met the inclusion criteria on the same day. The patients who volunteered to participate in the study were given COVID-19 isolation precautions (overall, N95 and surgical mask, visor and gloves, social distance) and made a home visit at the scheduled time, "Voluntary Consent Forms" were given, and they were received in a sealed envelope to ensure contact isolation. During the face-to-face meeting, all patients were given the "Favipiravir Use Brochure" prepared by the Ministry of Health, explaining how to use the drug, and the "COVID-19 Drug Schedule" follow-up form, and how this form should be filled. Approximately antiviral drugs were delivered to the patient. However, the home visit was terminated by informing the patients that a video phone call would be made on the second day of the treatment.A video phone call was made with all participants on the second day of treatment. First of all, the participants were informed that they would be asked some questions about their personal information and medication, that there was no right or wrong answer option in the questions, and the participants were asked to share the most appropriate answer without hesitation. The questions and answer options in the introductory information form and the Drug Compliance Notification Scale were conveyed to the participant without guidance, and the answers of the participants were recorded. By ending the interview, data on the descriptive characteristics of the participants were collected, and the scores of the drug compliance reporting scale were evaluated. After the initial evaluation, patients with a mean drug adherence score above 20 (n=124) were excluded from the study. At this stage, randomization was achieved by assigning the participants to the intervention and control groups using the double-block randomization method according to the order of the case date.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomised control trial
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: motivational interviewOn the second day of the COVID-19 antiviral drug treatment, the participant assigned to the intervention group was interviewed face-to-face during the home visit by providing isolation measures. In the face-to-face meeting, the "COVID-19 Medication Use Brochure" was given and it was stated that the participants would be video-talked about the topics included in the booklet at an appropriate time on the same day, and time was planned. In the interview, it was decided to allow the participant to tell about their antiviral drug use, to learn about their feelings, thoughts and behaviors about drug use, to reveal their feelings of indecision and anxiety about treatment, to determine their resistance to drug use, to reveal their intrinsic motivation, to support them and to change their behavior. It was intended to take action to advance the cycle of change. |
| control group | No intervention | –After randomization, the participants in the control group continued to receive health care according to the standard COVID-19 drug treatment procedures determined by the Ministry of Health. No other intervention was performed apart from the participant standard COVID-19 drug therapy procedures in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Those who volunteered to participate in the study
- 18 years old and over,
- Able to read and write Turkish,
- Having a COVID-19 patient followed at home,
- Having the equipment to make video calls over the internet connection,
Key exclusion criteria (3 listed)
- Contraindicated to use antiviral drug (Favipiravir) (liver failure, kidney failure, active chemotherapy treatment)
- Pregnant,
- Patients who were hospitalized for any reason during the study
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 interviewmotivational interview-based health education | Behavioural | intervention group |
Primary outcome
drug compliance reporting scale mean score
Time frame: 5 days
The Drug Compliance Reporting Scale is a Likert-type scale consisting of 5 items. The score to be taken from the scale is between 5 and 25. An increase in the scale score is interpreted as an increase in the level of drug compliance.
1 secondary outcome
increased drug compliance
Time frame: 5 days
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 9 Jan 2023.
- 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.
burcu yılmaz principal investigator
Ministry of Health
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 in people with Drug Compliance, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi 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 3 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 9 Jan 2023. 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?
drug compliance reporting scale mean score (time frame: 5 days). 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 9 Jan 2023.