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Trial record 3 of 234 for:    poverty | Recruiting, Not yet recruiting Studies | poor

A Novel Strategy to Develop a Rapid Screen, Simple Subgrouping and Precise Intervention Model for Older Adults With Poor Sleep Quality

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ClinicalTrials.gov Identifier: NCT04033601
Recruitment Status : Not yet recruiting
First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Poor sleep quality is a major issue of public health in older adults. However, the underlying cause of poor sleep quality in older adults is multifactorial and complex. A highly accessible and effective instrument for screening and subgrouping older adults with poor sleep quality is warranted. In particular, the instrument is expected to suggest respective interventions. The present project will use two groups, including non-disabled and disabled older adults, to develop the short screen and subgrouping scale along with the respective intervention. During the first and second year of the project, we will apply the established non-disabled version of' the 'Short Screen and Subgrouping Scale' to screen and to subgroup older adults with poor sleep quality in non-disabled older population. Consecutively, the screened subgroups will be performed the causal-pie analysis to elucidate the complex cause of poor sleep quality. The number of participants is estimated as 500. Meanwhile, additional 500 disabled older adults, who will be invited in the hospital, will be used in the latent class analysis (LCA) to subgroup reasonable classes of poor sleep quality in disabled older adults. According to the result of LCA, the disabled version of the 'Short Screen and Subgrouping Scale' will be produced and relevant causal-pie analysis will be conducted accordingly. In the second and third year of this project, two randomized control trials (RCT) with two arms will be conducted, respectively. One arm is non-pharmacological intervention group (n=30) and the other is the control group (n=30). In the non-disabled older adults, the screened mild insomnia group, which has been defined in our pilot study, will be invited to attend the RCT. In the disabled older adults, after the LCA, the subgroup with mild symptoms will be considered to enter the RCT study phase. The intervention for both RCTs will be designed according to the result of causal-pie analysis. The non-pharmacological intervention will comprise sleep hygiene education, exercise training and relevant modules of cognitive behavioral therapy. This 3-year project is expected to frame a population-level model of precision medicine, which targets poor sleep quality in older adults.

Condition or disease Intervention/treatment Phase
Poor Quality Sleep Behavioral: Non-pharmacological intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Novel Strategy to Develop a Rapid Screen, Simple Subgrouping and Precise Intervention Model for Older Adults With Poor Sleep Quality: Integrating Latent Class Analysis With Causal- Pie Analysis to Implement Population-based Precision Medicine
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Arm Intervention/treatment
Experimental: non-pharmacological intervention group Behavioral: Non-pharmacological intervention
The non-pharmacological intervention will comprise sleep hygiene education, exercise training and relevant modules of cognitive behavioral therapy.

Experimental: control group Behavioral: Non-pharmacological intervention
The non-pharmacological intervention will comprise sleep hygiene education, exercise training and relevant modules of cognitive behavioral therapy.




Primary Outcome Measures :
  1. Causal-pie analysis [ Time Frame: Up to 2 months ]
    The causal-pie analysis is used to elucidate the complex cause of poor sleep quality.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The age range of patients are above 65 years old.
  • Patients who have the ability to accept the exercise training.

Exclusion Criteria:

  • Patients with obvious mental retardation or organic brain syndrome.
  • Patients with dementia who cannot finish the questionnaire.
  • Heart disease history.
  • People who cannot apply to the demand.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04033601


Contacts
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Contact: Hsi-Chung Chen, Doctor (02)2381-3208 hsichungchen@ntuh.gov.tw

Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10002
Contact: Hsi-Chung Chen, Doctor    +886-2381-3208    hsichungchen@ntuh.gov.tw   
Sponsors and Collaborators
National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04033601    
Other Study ID Numbers: 201812192RINC
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
latent class analysis
causal-pie analysis
sleep quality
precision medicine
older adults
sleep medicine