NCT05671536

Brief Summary

This research consists of two stages: the first stage aims to evaluate the validity and reliability of the Hemodialysis Resilience Scale, which was developed to evaluate the resilience of patients receiving hemodialysis treatment, in Turkish society, and the second stage aims to determine the effect of motivational interviewing method on patients' psychological resilience and compliance with hemodialysis treatment in individuals undergoing hemodialysis. The main question it aims to answer is: Does motivational interviewing has an effect on psychological resilience and treatment compliance of hemodialysis patients?

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

April 26, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2023

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

9 months

First QC Date

January 2, 2023

Last Update Submit

January 3, 2023

Conditions

Keywords

Patient on hemodialysisresiliencenursingmotivational interview

Outcome Measures

Primary Outcomes (2)

  • Resilience

    Patient on Hemodialysis Resilience Scale is a valid and 5-point Likert type scale with minimum 0 and maximum 80 points. Higher score means higher resilience. Change=Higher score from Patient on Hemodialysis Resilience Scale at 5 months compared to baseline.

    Baseline and 5 months.

  • Compliance

    End Stage Renal Failure Compliance Scale is a valid and 5-point Likert type scale with minimum 0 and maximum 1200 points. Higher score means higher compliance. Change= Higher score from End Stage Renal Failure Compliance Scale at 5 months compared to baseline.

    Baseline and 5 months.

Study Arms (2)

Motivational interview

EXPERIMENTAL

Patients on intervention group will receive 4 sessions of motivational interview at least 20 minutes and once a month. Resilience of patients will be evaluated at the beginnig of the study and five months after the beginning of the study.

Behavioral: motivational interview

Control

NO INTERVENTION

Patients on control group will receive standard care. Resilience of patients will be evaluated at the beginnig of the study and five months after the beginning of the study.

Interventions

Intervention arm will receive motivational interview by the researcher, once a month for 4 times at least 20 minutes. The researcher received education about motivational interview.

Motivational interview

Eligibility Criteria

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

You may qualify if:

  • Receiving hemodialysis treatment for at least 3 months
  • years old and over
  • Oriantated
  • literate
  • Having no barrier to written or verbal communication
  • Agreed to participate in the research

You may not qualify if:

  • diagnosed with psychiatric illness
  • diagnosed with dementia and Alzheimer's

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University

Ankara, 06490, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
In order to reduce the selection bias in the determination of intervention and control groups, a list was created by a third party (dialysis center nurse) who did not have a direct role in the study, and intervention and control group assignments were made using the randomization method from the random numbers table. The intervention and control group patients were scheduled to have hemodialysis sessions on different days.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Patients, undergoing hemodialysis treatment will be assigned to either intervention or control group via simple randomization. Patients on control group will receive standard care. Patients on intervention group will receive 4 sessions of motivational interview at least 20 minutes and once a month. Resilience of all groups will be evaluated at the beginnig of the study and five months after the beginning of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 2, 2023

First Posted

January 4, 2023

Study Start

April 26, 2022

Primary Completion

January 30, 2023

Study Completion

March 25, 2023

Last Updated

January 4, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

The research will be published after completion and analysis.

Locations