- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04902716
Precision Nursing Intervention Program on Cognitive Function、Sleep Quality and Emotional State of Frail Female Elderly
The Effectiveness of Precision Nursing Intervention Program on Cognitive Function、Sleep Quality and Emotional State of Frail Female Elderly in the Community
Background: Taiwan's community population is aging rapidly, and women in the aging community account for the majority of frail elderly.In the process of aging, you must face changes in cognitive function, sleep disorders, and emotional state. Female elders have more impact on physical health than male elders. Precision nursing is a new trend in nursing in recent years. It is based on individual differences in disease type, gender, lifestyle, family, race, social and cultural factors, etc., to provide the most suitable empirical-based nursing treatment. It can also prevent and delay disability in improving the cognitive function, sleep quality and emotional state of frail female elderly in the community.
Purpose: This study explored the effectiveness of precision nursing intervention program on cognitive function,sleep quality and emotional state of frail female elderly in the community.
Methods: This study utilized a quasi-experimental research design. The subjects divided to 35 persons of experimental group and 35 people of comparison group. The experimental group implemented a weekly precision care program course for frail female elderly in the community for a total of 12 weeks; the control group maintained normal daily life. We collected cognitive function、sleep quality and emotional state from before and after intervention among frail female elderly in the community. The statistical methods uses were descriptive analysis, chi square, t test, generalized estimating equation (GEE), and difference-in-differences.
Expected benefit: The precise care plan of this study can benefit the cognitive function, sleep quality and emotional state of frail female elders in the community, and then extend it to various aging communities. According to the characteristics of the community elders and making good use of health policies and local resources, we will arrange and design appropriate courses to create a localized healthy aging life circle, and achieve the goal of preventing and delaying disability for the elderly and frail.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jui-Wen Yu, Master
- Phone Number: +886933264339
- Email: jwenyu0311@gmail.com
Study Locations
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-
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Hsinchu, Taiwan
- Recruiting
- Design course
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- (1) Elders over 65 years old can come and return home on their own. (2) Clear awareness and barrier-free communication. (3) Those who are frail or above detected by SOF screening, SOF ≥ 2 or above. (4) Agree to participate in this research and complete the consent form.
Exclusion Criteria:
-(1) Severe visual and hearing impairment, unable to cooperate with the researcher.
(2) Those whose limbs cannot participate in activities normally. (3) For chronic physical diseases, doctors have ordered those who are prohibited from exercising.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Precision Nursing, Frail women, Cognitive function, Sleep quality, Emotional state,
According to the characteristics of the elders in the community and making good use of health policies and local resources, a 12-week appropriate diversified curriculum is arranged as intervention measures.
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Precision nursing is a new trend in nursing in recent years.
It is based on individual differences in disease type, gender, lifestyle, family, race, social and cultural factors, etc., to provide the most suitable empirical-based nursing treatment.Diverse courses include music, breathing exercises, cognitive training, hand-made knitting, etc.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short Portable Mental State Questionnaire, SPMSQ
Time Frame: 1 week
|
The Short Portable Mental Status Questionnaire (SPMSQ) is a widely used 10-item cognitive screening instrument,whose items test orientation to time and place, memory, current event information (date, day of the week, name of this place, telephone number, date of birth, age, name of current prime minister and previous prime minister, mother's maiden name), and calculation (subtract 3s starting with number 20).
The total number of errors is computed and it ranges from 0 to 10.
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1 week
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Pittsburgh Sleep Quality Index, PSQI
Time Frame: 1 month
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The Pittsburgh Sleep Quality Index (PSQI),a self-rating questionnaire for measuring subjective sleep quality that specifically assesses the preceding I-month period .
The PSQI yields a global score that is the sum of seven component scores, each of which addresses a specific aspect of subjective sleep quality.
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1 month
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BSRS-5 (5-item Brief Symptom Rating Scale)
Time Frame: 1 week
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The five items of psychological symptoms and is commonly used for screening psychological disorders and is available in Taiwan with excellent validity and reliability .
For suicide prevention, the Taiwan BSRS-5 adds the sixth additional item that directly asks the subject about the urge of suicide attempts .
The BSRS-5 is a 5-item, self-administered questionnaire that is derived from the 50-item brief symptom rating scale, which measures anxiety , depression , hostility , interpersonal sensitivity , and additional symptoms .
The score for each item ranges from 0 to 4 (0, not at all; 1, a little bit; 2, moderately; 3, quite a bit; and 4, extremely).
A total score above 14, or a score of more than 1 on the additional suicide survey item.
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1 week
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Collaborators and Investigators
Publications and helpful links
General Publications
- Fu MR, Kurnat-Thoma E, Starkweather A, Henderson WA, Cashion AK, Williams JK, Katapodi MC, Reuter-Rice K, Hickey KT, Barcelona de Mendoza V, Calzone K, Conley YP, Anderson CM, Lyon DE, Weaver MT, Shiao PK, Constantino RE, Wung SF, Hammer MJ, Voss JG, Coleman B. Precision health: A nursing perspective. Int J Nurs Sci. 2019 Dec 24;7(1):5-12. doi: 10.1016/j.ijnss.2019.12.008. eCollection 2020 Jan 10. Erratum In: Int J Nurs Sci. 2020 Dec 06;8(1):III.
- Kidd T, Mold F, Jones C, Ream E, Grosvenor W, Sund-Levander M, Tingstrom P, Carey N. What are the most effective interventions to improve physical performance in pre-frail and frail adults? A systematic review of randomised control trials. BMC Geriatr. 2019 Jul 11;19(1):184. doi: 10.1186/s12877-019-1196-x.
- Romera-Liebana L, Orfila F, Segura JM, Real J, Fabra ML, Moller M, Lancho S, Ramirez A, Marti N, Cullell M, Bastida N, Martinez D, Gine M, Cendros P, Bistuer A, Perez E, Fabregat MA, Foz G. Effects of a Primary Care-Based Multifactorial Intervention on Physical and Cognitive Function in Frail, Elderly Individuals: A Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2018 Nov 10;73(12):1688-1674. doi: 10.1093/gerona/glx259.
- Wang WL, Chen KH, Pan YC, Yang SN, Chan YY. The effect of yoga on sleep quality and insomnia in women with sleep problems: a systematic review and meta-analysis. BMC Psychiatry. 2020 May 1;20(1):195. doi: 10.1186/s12888-020-02566-4.
- Puts MTE, Toubasi S, Andrew MK, Ashe MC, Ploeg J, Atkinson E, Ayala AP, Roy A, Rodriguez Monforte M, Bergman H, McGilton K. Interventions to prevent or reduce the level of frailty in community-dwelling older adults: a scoping review of the literature and international policies. Age Ageing. 2017 May 1;46(3):383-392. doi: 10.1093/ageing/afw247.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 202102EM014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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