NCT05398432

Brief Summary

The study was conducted to determine the effect of self-care supported motivational interviewing on patients receiving hemodialysis treatment on self-care power, disease compliance and metabolic variables. The study was completed with 77 patients. In the collection of data; Personal Information Form, Self-Care Strength Scale, Chronic Disease Adjustment Scale and Patient-Specific Metabolic Variables Form were used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

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

February 2, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2021

Completed
8 months until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

10 months

First QC Date

September 27, 2021

Last Update Submit

May 25, 2022

Conditions

Keywords

hemodialysisself caremotivational interview

Outcome Measures

Primary Outcomes (1)

  • self care power scale

    ıt is a scale used to measure an invidual's self-care abilit. the maximum score is 140. the hiğher the score obtained from the scale indicates the hiğh level of self-care ability and power of the invidual.

    6 week

Secondary Outcomes (1)

  • Chronic Disease Adjustment Scale

    6 week

Study Arms (2)

control

EXPERIMENTAL

The control group did not intervene

Other: motivational interview

experiment

EXPERIMENTAL

Initial data were collected after meeting the patients. Then, a total of 6 seans, 1 seans per week, were performed on the patients. Self-care training was given in the 1st, 2nd and 3rd seans. Motivational interviews were conducted in the 4th, 5th and 6th seans. After the first seans of the self-care supported motivational interview, the "Self Care and Adaptation Training Guide" prepared by the researcher in line with the literature was given to the experimental group. Second data were collected from patients after 6 weeks. Follow-up data were collected for 4 weeks without any intervention.

Other: motivational interview

Interventions

After the pre-test data were applied to all patients, before starting the motivational interview seans, the patients were informed about the interview intervals, duration, and how many times they would be held. In the second week, motivational interview seans were started with the patients. seans with patients took place during the hemodialysis seans. A total of 6 seans were held, one seans per week. After the first seans of the self-care supported motivational interview, the "Self-Care and Adaptation to Disease Training Guide" prepared by the researcher in line with the literature was given to the experimental group. Self-care training was given in the first, second and third seans. Motivational interviews were conducted in the fourth, fifth and sixth seans. Motivational interviewing techniques were used for patients to realize their self-care activities. seans were held individually with the patients and each seans lasted approximately 15-20 minutes.

controlexperiment

Eligibility Criteria

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

You may qualify if:

  • Receiving hemodialysis treatment for at least three months at the time of the study,
  • HD treatment for 3-4 hours 2 or 3 days a week,
  • years old and above,
  • Open to communication and cooperation,
  • Not visually or hearing impaired,
  • Being a reader and writer,
  • Not having any psychiatric diagnosis and/or not using any psychiatric medication,
  • Have not received motivational interviewing training before,
  • Individuals who agreed to participate in the study were included in the study.

You may not qualify if:

  • who are under the age of 18,
  • Having a communication problem,
  • Individuals who did not want to participate in the study or did not want to continue were excluded from the study.ı

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mus State Hospital

Muş, 49000_, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient Compliance

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • abdullah gerçek, doktora

    Muş Alparslan University

    PRINCIPAL INVESTIGATOR
  • serap parlar kılıç

    Inonu University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Randomization was performed to ensure that any observed changes in outcomes between the experimental and control groups were free from bias. Four sessions in the hemodialysis unit were listed and four lots were drawn by a person who was unaware of the study. The first draw was the experimental group, the second draw was the control group, the third draw was the experimental group, and the fourth draw was the control group. Thus, the patients in the morning and afternoon sessions on Monday-Wednesday-Friday constituted the control group, and the patients in the Tuesday-Thursday-Saturday morning and afternoon sessions constituted the experimental group.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized controlled trial design
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

September 27, 2021

First Posted

June 1, 2022

Study Start

February 2, 2020

Primary Completion

November 20, 2020

Study Completion

March 15, 2021

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

no, not shared with other people

Locations