Clinical trial NCT04953481: Home Care Needs and Current Nursing Status of Patients With Amyotrophic Lateral Sclerosis
Official title: Home Care Needs and Current Nursing Status of Patients With Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 252
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The outpatients, inpatients, discharged patients and their caregivers of ALS in a general hospital in Beijing.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

-

The inclusion criteria of ALS patients:

1. 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;
   * 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.

   Exclusion Criteria:

   -

   Exclusion criteria of ALS patients:

   ① severe physical diseases, such as malignant tumor, liver and kidney dysfunction, etc;

   ② They are participating in other intervention projects.

   Exclusion criteria of caregivers:
   * severe physical diseases, such as malignant tumor, liver and kidney dysfunction, etc; ② They are participating in other intervention projects.

Primary outcomes:
measure: the Barthel index of ADL
timeFrame: At the time of survey (day 0)
Secondary outcomes:
measure: Caregiver Burden Inventory, CBI
timeFrame: At the time of survey (day 0)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
References: