Amyotrophic Lateral SclerosisNCT04953481
Home Care Needs and Current Nursing Status of Patients With Amyotrophic Lateral Sclerosis
An observational study of Amyotrophic Lateral Sclerosis, run by Peking University Third Hospital at 1 site in China.
Trial summary
The purpose of this study is to comprehensively investigate and analyze the home care needs and status quo of ALS patients in China, and to clarify their home care needs and status quo, so as to provide reference for the development of home care service planning and policy measures for ALS patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- survey
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2022
- 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: The outpatients, inpatients, discharged patients and their caregivers of ALS in a general hospital in Beijing.
Who may be able to join
- -
- The inclusion criteria of ALS patients:
- They met the diagnostic criteria of Chinese guidelines for the diagnosis and treatment of amyotrophic lateral sclerosis; ② Receiving care at home; ③ No cognitive impairment (if the patient is unable to talk and write due to illness, the family members can express it for the patient);
- ④ Informed consent, willing to participate in this study;
- ⑤ No mental illness.
- The inclusion criteria of caregivers: ① the primary caregiver designated by the patient was responsible for the primary care;
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- They are relatives of patients;
- No payment for care; ④ Informed consent, willing to participate in this study;
- No mental illness; ⑥ There was no cognitive impairment.
Who cannot join
- -
- ① severe physical diseases, such as malignant tumor, liver and kidney dysfunction, etc;
- ② They are participating in other intervention projects.
- severe physical diseases, such as malignant tumor, liver and kidney dysfunction, etc; ② They are participating in other intervention projects.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Baohua Li, 15611908581, lianglbh@126.com
About this study
The purpose of this study is to comprehensively investigate and analyze the home care needs and status quo of ALS patients in China, and to clarify their home care needs and status quo, so as to provide reference for the development of home care service planning and policy measures for ALS patients.
Read the detailed description
Amyotrophic lateral sclerosis (ALS) is the most common type of motor neuron disease. It is common in middle-aged and elderly people. Progressive skeletal muscle weakness, atrophy, fascicular fibrillation, bulbar paralysis and pyramidal tract sign are the main clinical manifestations. The survival time is usually 3-5 years. As the pathogenesis of ALS is not fully understood, there is no specific treatment for ALS. The clinical treatment mode of most patients with ALS is hospitalization at the end of the disease and maintenance treatment at home during the disease progression. At present, there are few reports on the home care needs and nursing status of ALS patients in China. This study is a cross-sectional survey. Based on consulting the relevant literature and consulting experts' opinions, the researchers designed the questionnaire of home care needs and nursing status of ALS patients, The convenience sampling method was used to select 126-252 ALS outpatients, 126-252 ALS inpatients, and 126-252 ALS family members from a third class a general hospital in Beijing. The needs and status of home care of ALS patients in China were comprehensively investigated and analyzed, and the needs and status of home care were clarified, so as to provide reference for the development of home care service planning and policy measures for ALS patients.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- 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.
surveyOther
The general information, home care status and functional status of ALS patients and family caregivers were collected.
| Study group | Role | What they receive |
|---|---|---|
| Amyotrophic lateral sclerosis group | Patients with amyotrophic lateral sclerosis undergoing home care. Receives: Other: survey | |
| Caregiver group | Caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Barthel index of ADL
the Barthel index of ADL
Measured: At the time of survey (day 0)
Secondary outcomes (1)
Caregiver Burden Inventory, CBI
Caregiver Burden Inventory, CBI
Measured: At the time of survey (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 252 participants (estimated)
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
- NCT04953481
- Sponsor's protocol ID
- M2021023
- Status last verified
- Jul 2021
- First submitted
- 27 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- 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 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Care Needs and Current Nursing Status of Patients With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT04953481
- Acronym / sponsor ID
- M2021023
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 8 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 purpose of this study is to comprehensively investigate and analyze the home care needs and status quo of ALS patients in China, and to clarify their home care needs and status quo, so as to provide reference for the development of home care service planning and policy measures for ALS patients.
Detailed description
Amyotrophic lateral sclerosis (ALS) is the most common type of motor neuron disease. It is common in middle-aged and elderly people. Progressive skeletal muscle weakness, atrophy, fascicular fibrillation, bulbar paralysis and pyramidal tract sign are the main clinical manifestations. The survival time is usually 3-5 years. As the pathogenesis of ALS is not fully understood, there is no specific treatment for ALS. The clinical treatment mode of most patients with ALS is hospitalization at the end of the disease and maintenance treatment at home during the disease progression. At present, there are few reports on the home care needs and nursing status of ALS patients in China. This study is a cross-sectional survey. Based on consulting the relevant literature and consulting experts' opinions, the researchers designed the questionnaire of home care needs and nursing status of ALS patients, The convenience sampling method was used to select 126-252 ALS outpatients, 126-252 ALS inpatients, and 126-252 ALS family members from a third class a general hospital in Beijing. The needs and status of home care of ALS patients in China were comprehensively investigated and analyzed, and the needs and status of home care were clarified, so as to provide reference for the development of home care service planning and policy measures for ALS patients.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amyotrophic lateral sclerosis group | – | Other: surveyPatients with amyotrophic lateral sclerosis undergoing home care. |
| Caregiver group | – | –Caregivers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The outpatients, inpatients, discharged patients and their caregivers of ALS in a general hospital in Beijing.
Key inclusion criteria (9 listed)
- -
- They met the diagnostic criteria of Chinese guidelines for the diagnosis and treatment of amyotrophic lateral sclerosis; ② Receiving care at home; ③ No cognitive impairment (if the patient is unable to talk and write due to illness, the family members can express it for the patient);
- ④ Informed consent, willing to participate in this study;
- ⑤ No mental illness.
- The inclusion criteria of caregivers: ① the primary caregiver designated by the patient was responsible for the primary care;
Key exclusion criteria (4 listed)
- -
- ① severe physical diseases, such as malignant tumor, liver and kidney dysfunction, etc;
- ② They are participating in other intervention projects.
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 |
|---|---|---|
| surveyThe general information, home care status and functional status of ALS patients and family caregivers were collected. | Other | Amyotrophic lateral sclerosis group |
Primary outcome
the Barthel index of ADL
Time frame: At the time of survey (day 0)
the Barthel index of ADL
1 secondary outcome
Caregiver Burden Inventory, CBI
Time frame: At the time of survey (day 0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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.
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 9 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Barthel index of ADL (time frame: At the time of survey (day 0)). 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 8 Jul 2021.