Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04250103
Other study ID # EC1080203
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date November 20, 2019
Est. completion date December 31, 2022

Study information

Verified date January 2020
Source National Health Research Institutes, Taiwan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Some research found the effectiveness of implementation of home health care on patients' physical function, quality of life (QoL) and decreased the risk of hospitalization and medical costs. However, little was known about the longitudinal change of comprehensive assessments of physical and mental health, QoL, well-being, and medical resource utilization of patients receiving home health care and their caregivers. Furthermore, the evaluation of advance care planning, palliative care need, and the quality of dying and death were also insufficient among the aforementioned population. Therefore, this cohort study aims to investigate the longitudinal change of health-related outcomes and utilization of resource utilization, and explore their trajectories in two years for patients who receive home health care and their caregivers in Taiwan.


Description:

This is a prospective longitudinal cohort study in Taiwan. Data will be collected by trained interviewers at the baseline (T0), 3-month follow-up (T1), 6-month follow-up (T2), 12-month follow-up (T3), 18-month follow-up (T4), and 24-month follow-up (T5). Via home visits, interviewer-administered questionnaires (informed consent, contact/follow-up information, background information, health condition, physical functioning, cognitive function, etc.) will be used. It estimates that the home visit will take up to 2 hours.

The investigators will recruit at least 1200 eligible patients and caregivers (600 dyads) from at least 15 institutions (e.g., home clinics and hospitals) which provide home health care. Trained research assistants will touch based with eligible participants recommended by institution staff and invite them to take part in the study. To ensure the study are achieving the target sample the investigators will examine the distribution of living area and number of participants in each type of home health care unit during recruiting. Moreover, the investigators have estimated an attrition rate of 20% over the study. Higher drop-off rates in certain sub-groups may be problematic, so the investigators will monitor participants' attrition.

In addition, the cohort the investigators enrolled will be linked to their data in Taiwan's National Health Insurance Research Database to analyze the medical resource utilization of participants in our study. The results will show the health status and resource utilization as well as quality of home health care in Taiwan for clinical practices, research and future policy making.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1200
Est. completion date December 31, 2022
Est. primary completion date November 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Aged 20 years or older

- Receiving home health care services at least two months

- Either the patient or caregiver can express clearly

Exclusion Criteria:

- Reject to sign the informed consent

- Both the patient and caregiver cannot complete the interview

- Both the patient and caregiver cannot communicate with an interviewer in a familiar language

Study Design


Locations

Country Name City State
Taiwan Chao A. Hsiung Zhunan Miaoli County

Sponsors (2)

Lead Sponsor Collaborator
National Health Research Institutes, Taiwan Taiwan Society of Home Health Care

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from ability to perform activities of daily living (ADL) at two years The Barthel Index will be adapted to assess ADL. The total score ranges from 0 to 100, with 100 indicating full independence in doing daily activities. Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary Change from frailty at two years It will be measured by the 9-point Clinical Frailty Scale (CFS). The total score ranges from 1 to 9, with 7 or higher indicating severe frailty, even being terminally ill. Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary Change from cognitive function/memory at two years It will be measured by the Brain Health Test (Chinese version) via testing the orientation to time, immediate and delayed recall of five items, categorical verbal fluency test. The total score ranges from 0 to 16, with higher scores indicating worse cognitive impairment. Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary Change from percentage of participants with Dementia at two years The Functional Assessment Staging Test (FAST) will be adapted to assess an individual's stage of Alzheimer's disease. It includes seven stages from normal aging to sever Dementia. Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary Change from mean score of depression at two years It will be measured by the 5-item Geriatric Depression Scale (GDS). The total score ranges from 0 to 5, with higher scores indicating more depression. Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary Change from neuropsychiatric status at two years It will be measured by the Neuropsychiatric Inventory. The 10 sub-domains of behavioral functioning are examined, including delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, and aberrant motor activity syndrome. Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary Change from quality of life (QOL) at two years We will adapt the Quality of Life in Alzheimer's Disease (QOL-AD) scale for patients with cognitive impairment, and Quality of Life Survey for Home Care (QOL-HC) scale for those without cognitive impairment. The total score of QOL-AD ranges from 13 to 52, with higher values indicating a higher QoL. The total score of QOL-HC ranges from 0 to 8, with higher values indicating a higher QoL. Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary Change from mental wellbeing at two years It will be measured by the World Health Organization- Five Well-Being Index (WHO-5). The raw score ranges from 0 to 25, 0 representing worst possible and 25 representing best possible quality of life. Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary Shared decision making (SDM) It will be measured by the Decision-making Participation Self-Efficacy Scale (DEPS). The total score ranges from 5 to 25, with higher scores indicating higher self-efficacy. Two years
Primary Advance Care Planning (ACP) It will be measured by the 4-question version of UCSF-ACP with the Process Measures (knowledge, contemplation, self-efficacy, and readiness, 5-point Likert scales) and Action Measures (yes/no whether an ACP behavior is completed). Two years
Primary Change from Nutrition status at two years It will include the Mini Nutritional Assessment (MNA). The total score of MNA ranges from 0-14, with more than 11 indicating normal nutrition status. Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary Change from risk for pressure injury at two years It will be measured by the sale of Braden Scale for Predicting Pressure Sore Risk. The scale is composed of six subscales that reflect sensory perception, skin moisture, activity, mobility, friction and shear, and nutritional status. The total score ranges from 6 to 23, with higher scores indicating lower risk for forming pressure sores. Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary Needs assessment for supportive & palliative care It will be measured by the Supportive & Palliative Care Indicators Tool (SPICT). Following the guideline, the Chinese version will be developed before the cohort study starts. Two years
Primary Change from medical resource utilization at two years Assessments include medical costs and out-of-pocket costs regarding utilization of medical resource and home health care. The used scales are developed by our research team. Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up
Primary Change from caregiving burden at two years It will be measured by the revised version of Zarit Burden interview containing 22 items, with higher scores indicating greater burden. Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
Primary Change from number of used chronic disease drug at two years It will be measured by two items which are developed by our research team. Based on patients' prescriptions, they will be required to answer the number of chronic disease drug they used and these drugs' information, including the names, administrations and dosages. Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
See also
  Status Clinical Trial Phase
Recruiting NCT05596474 - Effect of Beet-root Juice and PBM Treatments on Muscle Fatigue N/A
Recruiting NCT05778578 - Universal Basic Income and Structural Racism in the US South N/A
Not yet recruiting NCT05558332 - Youth Nominated Support Team N/A
Completed NCT02451059 - Reducing Socioeconomic Disparities in Health at Pediatric Visits N/A
Completed NCT05082935 - COVID-19: Healthy Oregon (Oregon Saludable): Together We Can (Juntos Podemos) Phase II N/A
Recruiting NCT05454969 - One-4-ALL Initiative N/A
Enrolling by invitation NCT05045222 - Economic and Clinical Outcomes of (Whole Exome) Sequencing in Tapestry
Completed NCT04587063 - Evaluation of Emails Promoting Mail-order Pharmacy N/A
Recruiting NCT05541913 - The Effect of Tele-Nursing on Parents of Circumcised Children N/A
Completed NCT05117333 - Reminders, Cost Sharing, and Healthcare Use N/A
Recruiting NCT04835012 - Health and Health Care Utilization Effects of Medical Debt Forgiveness
Completed NCT04567342 - Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of MMR Vaccination N/A
Withdrawn NCT05552638 - Telecare in Rural Senior Centers N/A
Completed NCT04240093 - CoMBAT Opioid Use Disorder: A Combined Medication and Behavioral Activation Treatment for People Living With Opioid Use Disorder N/A
Active, not recruiting NCT03724695 - Advanced Heart Care at Home N/A
Completed NCT04517578 - European Neuromuscular Monitoring Survey
Active, not recruiting NCT05609188 - Black Economic Equity Movement N/A
Completed NCT04373135 - Understanding Community Considerations, Opinions, Values, Impacts, and Decisions for COVID-19 N/A
Recruiting NCT05324566 - Evaluation of ECG Transmission and AI Models Using Apple Watch ECGs and Symptoms Data Collected Using a Mayo iPhone App
Completed NCT04904744 - Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of COVID-19 Vaccination N/A