NCT04047069

Brief Summary

The aim of this study is to investigate the effect of person-centre occupational therapy intervention on activity performance and quality of life in hemodialysis patients. The results of the study will guide the intervention programs for prevention, coping and improving the quality of life of HD 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
42

participants targeted

Target at P25-P50 for not_applicable quality-of-life

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable quality-of-life

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

July 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

1 month

First QC Date

August 1, 2019

Last Update Submit

August 3, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of life (with a quality of life scale specific to renal patients).

    The KidneyDisease Quality of Life (KDQOL-36) consists of the SF-12, which measures physical and mental functioning, Burden of Kidney Disease subscale, Symptoms and Problems subscale, and Effects of Kidney Disease on Daily Life subscale. The scores of theKDQOL-36 questionnaire are transformed into 0 to 100, with higherscores indicating better quality of life.combines the generic SF-36 Health Survey instrument and disease-specific components for assessing the health-related quality of life of

    1st day of study

Study Arms (2)

Control

OTHER

Awareness Training

Behavioral: Awareness Training

Intervention group

EXPERIMENTAL

* Awareness Training * Person-Centered Occupational Therapy Intervention

Behavioral: Awareness Training and Person-Centered Occupational Therapy Intervention

Interventions

Exp. identifying the activities the person wants to do, suggestions to facilitate the activity, arranging the activity according to the needs of the person, arranging the environment so that the environment can be a facilitating factor in the activities the person wants to do.

Intervention group

Exp. * General information about HD * Approaches to Coping with HD Symptoms * Self care skills (eg hygiene)

Control

Eligibility Criteria

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

You may qualify if:

  • diagnosed as chronic renal failure.
  • between 18-65 years
  • undergoing HD treatment for at least 1 year

You may not qualify if:

  • Beck Depression Scale score of 17 or higher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Özgü İnal

Edirne, 22100, Turkey (Türkiye)

Location

Study Officials

  • Özgü İnal

    Trakya University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 1, 2019

First Posted

August 6, 2019

Study Start

July 1, 2019

Primary Completion

August 12, 2019

Study Completion

October 30, 2019

Last Updated

August 6, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations