NCT05955703

Brief Summary

This study was conducted to evaluate the effect of a Precede-Proceed Model-based (PPM-based) training program on treatment adherence, healthy lifestyle behaviors, and quality of life of hemodialysis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

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

October 18, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

June 1, 2023

Last Update Submit

July 19, 2023

Conditions

Keywords

Adherence to treatmenthealthy lifestyle behaviorhemodialysisnursingprecede-proceed modelquality of life

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the Effect of the Training Program based on the Precede-Proceed Model on quality of life style of Hemodialysis Patients

    The patients' quality of life was evaluated with the SF-12 Quality of Life scale. The scale consists of 12 items. There is no breakpoint. The higher the score obtained from the scale, the higher the quality of life.

    six month

Secondary Outcomes (1)

  • 2. Evaluation of the Effects of the Continuation Test (follow-up test results 3 months after the post-test) and the Education Program Based on the Pre-Continuation Model on the Quality of Life of Hemodialysis Patients

    three month

Study Arms (2)

Using the experimental group as a result of the training based on PPM

EXPERIMENTAL

The training sessions planned within the scope of PPM were applied to the patients, who were divided into groups of six according to the bed order, for 15-20 minutes for eight weeks, when the patients felt well, through training booklets and power point presentations. When the trainings started, the posters prepared were hung in the waiting room while the intervention group was undergoing hemodialysis. The person providing the care of the patient was included in each training. During the trainings, it was requested that the training booklets be with the patients and the power point presentations continued in parallel with the training booklets. * Post-test was applied to intervention group * three months after the post-test application, follow-up test was applied to the intervention group in order to evaluate the impact.

Behavioral: ppm based training

Using the control group as a result of the training based on PPM

NO INTERVENTION

After the follow-up test, training was given to the patients in the control group and a model-based training booklet was distributed.

Interventions

The training program based on the precede proceed model was applied to hemodialysis patients for 8 sessions. Eight sessions of training were given to the experimental group within the scope of the model, a booklet was developed in line with the trainings and posters were prepared.

Using the experimental group as a result of the training based on PPM

Eligibility Criteria

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

You may qualify if:

  • years of age or older,
  • Hemodialysis treatment for at least 6 months,
  • A total score of 1 or more from the Dialysis Diet and Fluid Restriction Non-Compliance Scale,
  • A score between 1 and 7 on the scale of compliance with medical treatment,
  • Place, time, person orientation,
  • Does not have a psychiatric illness or a problem that prevents written or verbal communication,

You may not qualify if:

  • Diagnosed with psychiatric illness Individuals with a diagnosis of malignancy wanting to leave research
  • Those who do not attend all of the trainings / do not want to continue
  • Individuals whose general condition is deteriorated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Yakutiye, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

June 1, 2023

First Posted

July 21, 2023

Study Start

October 18, 2021

Primary Completion

December 8, 2022

Study Completion

December 8, 2022

Last Updated

July 21, 2023

Record last verified: 2023-07

Locations