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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • University of Health Sciences

    Ankara

Other trials in Turkey (Türkiye)

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 groups in NCT05676021
Study groupRoleWhat they receive
intervention groupExperimentalOn 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 groupNo interventionAfter 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.

  1. 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)
  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.

  1. First posted9 Jan 2023
  2. Study start15 Jun 2021
  3. Primary completion20 Dec 2021
  4. Study completion20 Jan 2022

Resources

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)
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

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.

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