Amyotrophic Lateral SclerosisNCT04950231
Investigation on Home Care Needs of ALS Patients and Their Caregivers
An observational study of Amyotrophic Lateral Sclerosis, run by Peking University Third Hospital at 1 site in China.
Trial summary
The research target 1. To investigate the home nursing knowledge needs of ALS patients; 2. Investigate the needs of ALS caregivers for home nursing knowledge; 3. 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- The questionnaire survey
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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.
Who may be able to join
- confirmed and suspected patients of ALS diagnostic criteria revised by E1 Escorial in 1998;Conscious and stable vital signs;Signing the informed consent;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation on the Knowledge Needs of ALS Patients and Their Caregivers at Home
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.
Read the 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)
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- The questionnaire survey
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The questionnaire surveyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale
Scale: Self-designed questionnaire Questionnaire on the Degree of Home Nursing Knowledge Needs of ALS Patients or Their Family Members;
Measured: 1 year after recruitment
Secondary outcomes (1)
(ALS FRS)
Amyotrophic Lateral Sclerosis Function Scale (ALS FRS)
Measured: 1 year after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Sep 2020
- Primary completion1 Feb 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950231
- Sponsor's protocol ID
- M2020082
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Knowledge Needs of ALS Patients and Their Caregivers at Home
- ClinicalTrials.gov ID
- NCT04950231
- Acronym / sponsor ID
- M2020082
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 6 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (1 listed)
- confirmed and suspected patients of ALS diagnostic criteria revised by E1 Escorial in 1998;Conscious and stable vital signs;Signing the informed consent;
Key exclusion criteria (1 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The questionnaire surveyQuestionnaires 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. | Other | – |
Primary outcome
Scale
Time frame: 1 year after recruitment
Scale: Self-designed questionnaire Questionnaire on the Degree of Home Nursing Knowledge Needs of ALS Patients or Their Family Members;
1 secondary outcome
(ALS FRS)
Time frame: 1 year after recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale (time frame: 1 year after recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021.