NCT05676021

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
Last Updated

January 9, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

December 20, 2022

Last Update Submit

January 4, 2023

Conditions

Keywords

COVID-19Medication ComplianceMotivational InterviewingHealth Education

Outcome Measures

Primary Outcomes (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.

    5 days

Secondary Outcomes (1)

  • increased drug compliance

    5 days

Study Arms (2)

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.

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.

Interventions

motivational interview-based health education

intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those who volunteered to participate in the study
  • 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

You may not qualify if:

  • Contraindicated to use antiviral drug (Favipiravir) (liver failure, kidney failure, active chemotherapy treatment)
  • Pregnant,
  • Patients who were hospitalized for any reason during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Medication AdherenceCOVID-19Health Education

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesAdherence Interventions

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • burcu yılmaz

    Ministry of Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomised control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, RN

Study Record Dates

First Submitted

December 20, 2022

First Posted

January 9, 2023

Study Start

June 15, 2021

Primary Completion

December 20, 2021

Study Completion

January 20, 2022

Last Updated

January 9, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations