NCT05000606

Brief Summary

The aim of this study was to determine the effect of a home visit program provided to the caregivers of asthmatic patients on the perceived care burden. A randomized controlled trial was used. The sample consisted of 30 participants in the intervention group and 30 participants in the control group. A home visit program including education and counseling was applied to participants in the intervention group.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

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

November 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
Last Updated

July 8, 2024

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

July 29, 2021

Last Update Submit

July 4, 2024

Conditions

Keywords

asthmaburdencaregivereducationhome visit

Outcome Measures

Primary Outcomes (3)

  • Zarit Caregiver Burden Scale

    The scale consists of 18 questions. The minimum test score is 0 and the maximum score is 72. Care burden increases as the score from the scale increases.

    Baseline

  • Zarit Caregiver Burden Scale

    The scale consists of 18 questions. The minimum test score is 0 and the maximum score is 72. Care burden increases as the score from the scale increases.

    Change from Baseline Perceived Care Burden Scores at 1 month

  • Zarit Caregiver Burden Scale

    The scale consists of 18 questions. The minimum test score is 0 and the maximum score is 72. Care burden increases as the score from the scale increases.

    Change from 1 month Perceived Care Burden Scores at 3rd months

Study Arms (2)

A home visit program

EXPERIMENTAL

A home visit program including five visits over three months were performed.

Other: A home visit program

Control

NO INTERVENTION

No other intervention was applied to the control group other than the standard education given in the outpatient clinic

Interventions

A home visit program including education and counseling was applied. A total of five home visits over three months were performed.

A home visit program

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • giving care to a patient who was poorly controlled or uncontrolled asthma
  • giving care to a patient who used an inhaler
  • age 18 or over
  • volunteering to participate to the study

You may not qualify if:

  • having a disease with a neuro-psychiatric diagnosis
  • having vision and hearing problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Faculty of Nursing, Nursing Department

Study Record Dates

First Submitted

July 29, 2021

First Posted

August 11, 2021

Study Start

November 1, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

July 8, 2024

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share