Investigation on Home Care Needs of ALS Patients and Thei... | NCT04950231

Studies
Investigation on Home Care Needs of ALS Patients and Their Caregivers

NCT04950231

Sponsor

Peking University Third Hospital

Status

Completed

Last Update Posted

Jul 6, 2021Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Amyotrophic Lateral Sclerosis

Interventions

The questionnaire survey

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Feb 1, 2021Actual

Completion Date

May 1, 2021Actual

First Submitted Date

Jun 27, 2021

First Submission Date that Met QC Criteria

Jul 2, 2021

First Posted Date

Jul 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2021

Last Update Posted Date

Jul 6, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The research target

To investigate the home nursing knowledge needs of ALS patients;
Investigate the needs of ALS caregivers for home nursing knowledge;
To compare the differences between patients and caregivers in the knowledge needs of patients' refusal to care, so as to provide patients and caregivers with targeted care, meet the needs of patients, improve the quality of life of patients, and extend the survival period.

Detailed Description

The research target

To investigate the home nursing knowledge needs of ALS patients;
Investigate the needs of ALS caregivers for home nursing knowledge;
To compare the differences between patients and caregivers in the knowledge needs of patients' refusal to care, so as to provide patients and caregivers with targeted care, meet the needs of patients, improve the quality of life of patients, and extend the survival period.

Assessment indicators

Scale: Self-designed questionnaire "Questionnaire on the Degree of Home Nursing Knowledge Needs of ALS Patients or Their Families";
Amyotrophic lateral sclerosis function rating scale (ALS FRS)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The questionnaire survey	Other	Questionnaires were issued and collected by 6 competent nurses with strict training, data entry by 2 researchers, statistical analysis by 1 researcher, and quality control by the other 2 researchers throughout the process.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Scale	Scale: Self-designed questionnaire Questionnaire on the Degree of Home Nursing Knowledge Needs of ALS Patients or Their Family Members;	1 year after recruitment

Secondary Outcomes

Measure	Description	Time Frame
(ALS FRS)	Amyotrophic Lateral Sclerosis Function Scale (ALS FRS)	1 year after recruitment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

confirmed and suspected patients of ALS diagnostic criteria revised by E1 Escorial in 1998;Conscious and stable vital signs;Signing the informed consent;

Exclusion Criteria:

patients with severe medical diseases, such as severe cardiovascular and cerebrovascular diseases, liver and kidney failure, etc.The existing resources cannot complete the questionnaire to fill in the exclusion of patients, but the caregivers can fill in the questionnaire;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Six rigorously trained nurses in charge will issue and collect the questionnaire, two researchers will enter the data, one researcher will perform statistical analysis of the data, and the other two researchers will control the quality of the whole process.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Yniversity Third Hospital		Beijing			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000690	Amyotrophic Lateral Sclerosis

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016472	Motor Neuron Disease

Browse Leaves

Not provided

Browse Branches

Not provided