NCT06102317

Brief Summary

There are studies in the literature aimed at supporting parents who care for children who have Cerebral Palsy. Among these, the study conducted on the use of mobile applications in supporting parents has attracted attention in recent years. When the studies on supporting parents were examined, it was found in one study that a mobile application designed for caregivers enabled parents to support their children's nutrition, bathing, toileting, playing, carrying, and movement training. As a result of this study, it was reported that the knowledge and skills of caregivers regarding the care of their children increased. It was emphasized in another study that mobile medicine applications that are developed for children who have disabilities such as Cerebral Palsy must have a drug list, drug name, drug reminder module, drug registration section, and additional characteristics. In a randomized controlled study, it was reported that a web-based daycare program designed for the children of mothers who had children with CP increased the quality of life of the mothers. In another study, it was explained to caregivers of children who had Cerebral Palsy that the application facilitated the daily care of children anytime and anywhere in a training module consisting of a mobile application with information about CP, nutrition, toilet, bath, transportation, games, and medication reminder modules. Studies conducted on the use of technology-based (telehealth, mobile applications, web-based education) healthcare service delivery, education, and consultancy services in supporting families in Turkey are limited. The present study aimed to reduce the care burden and stress of parents of children who had Cerebral Palsy and improve their quality of life with the mobile application developed with the support of nurses. The purpose of the present study is to examine the effects of smartphone-supported nursing consultancy applied to mothers of children who have Cerebral Palsy receiving home healthcare services on their care burden, coping with stress, and quality of life

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

October 8, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

October 8, 2023

Last Update Submit

October 20, 2023

Conditions

Keywords

"Cerebral Palsy""Quality of Life""Caregiver Burden""Smartphone"

Outcome Measures

Primary Outcomes (1)

  • the effect of nurse-assisted telephone application on quality of life, stress and care burden in mothers with cerebral palsy children

    the change in the total scores of the smartphone mobile application applied nurse-assisted to the mothers in the intervention group on the stress, care burden and quality of life scale in the mothers in the intervention group in the study conducted at the end of 4 weeks

    1 month

Secondary Outcomes (1)

  • the effect of nurse-assisted telephone application on quality of life, stress and care burden in mothers with cerebral palsy children

    3 month

Other Outcomes (1)

  • the effect of nurse-assisted telephone application on quality of life, stress and care burden in mothers with cerebral palsy children

    6 month

Study Arms (2)

Intervention group

EXPERIMENTAL

In the study, mobile application will be installed on the phones of the mothers in the initiative group and individual information will be provided about how the patients will use the smartphone application. . Information will be provided to patients for subsequent follow-ups. After the application is started to be used, notifications of the applications developed in Smart Mobile for the disease management process will be made to the mothers of the Initiative Group every two weeks for six months. In addition, the Initiative Group will continue to receive standard care practices such as examinations, examinations, tests, treatment, medical care and rehabilitation offered by the Home Health Services unit.

Other: nursing consultancy with smartphone support

control group

NO INTERVENTION

No attempts will be made to the control group. The control group will continue to receive the standard care practices offered by the Home Health Services unit.

Interventions

In the study, mobile application will be installed on the phones of the mothers in the initiative group and individual information will be provided about how the patients will use the smartphone application. . Information will be provided to patients for subsequent follow-ups. After the application is started to be used, notifications of the applications developed in Smart Mobile for the disease management process will be made to the mothers of the Initiative Group every two weeks for six months. In addition, the Initiative Group will continue to receive standard care practices such as examinations, examinations, tests, treatment, medical care and rehabilitation offered by the Home Health Services unit.

Intervention group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Having a child with CP registered in the Home Healthcare Services Unit at S.B.U Dr. Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital
  • Residing in the province of Izmir and at home
  • Having a primary diagnosis of Cerebral Palsy in the home health care file
  • The primary caregiver of the child is the mother
  • The mother does not have any communication or mental problems
  • The mother's ability to read and write in Turkish
  • Having an Android or IOS-based smartphone
  • Voluntary participation in the study

You may not qualify if:

  • \. Children who were residing in the Ministry of Family and Social Policies Services.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral PalsyCaregiver Burden

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Effects of Smartphone-assisted Nursing Care Used for Mothers of Children With Cerebral Palsy Who Receive Home Healthcare Services on the Care Burden, Coping With Stress, and Quality of Life of Mothers

Study Record Dates

First Submitted

October 8, 2023

First Posted

October 26, 2023

Study Start

February 1, 2024

Primary Completion

April 30, 2024

Study Completion

July 31, 2024

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share