The Effectiveness of Precision Nursing Intervention Program on Cognitive Function、Sleep Quality and Emotional State of Frail Femal Elderly in the CommunityNCT04902716
Precision Nursing Intervention Program on Cognitive Function、Sleep Quality and Emotional State of Frail Female Elderly
A study testing Design course in people with The Effectiveness of Precision Nursing Intervention Program on Cognitive Function、Sleep Quality and Emotional State of Frail Femal Elderly in the Community, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 90 years, women only
- Conditions the study is for
- The Effectiveness of Precision Nursing Intervention Program on Cognitive Function、Sleep Quality and Emotional State of Frail Femal Elderly in the Community
- What is being tested?
- Design course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Apr 2021to 30 Jun 2022
- Phase
- Interventional
- 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 65 to 90 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- (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.
Who cannot join
- -(1) Severe visual and hearing impairment, unable to cooperate with the researcher.
- Those whose limbs cannot participate in activities normally. (3) For chronic physical diseases, doctors have ordered those who are prohibited from exercising.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- Design course
- Keywords
- Precision Nursing, Frail women, Cognitive function, Sleep quality, Emotional state
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Design courseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Precision Nursing, Frail women, Cognitive function, Sleep quality, Emotional state, | Experimental | 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. Receives: Behavioral: Design course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Portable Mental State Questionnaire, SPMSQ
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.
Measured: 1 week
Pittsburgh Sleep Quality Index, PSQI
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.
Measured: 1 month
BSRS-5 (5-item Brief Symptom Rating Scale)
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start28 Apr 2021
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for The Effectiveness of Precision Nursing Intervention Program on Cognitive Function、Sleep Quality and Emotional State of Frail Femal Elderly in the CommunityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jui-Wen Yu, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902716
- Sponsor's protocol ID
- 202102EM014
- Status last verified
- May 2021
- First submitted
- 21 May 2021
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32099853Kidd 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.
PubMed 31291884Romera-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.
PubMed 29346524Wang 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.
PubMed 32357858Puts 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.
PubMed 28064173
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Precision Nursing Intervention Program on Cognitive Function、Sleep Quality and Emotional State of Frail Female Elderly in the Community
- ClinicalTrials.gov ID
- NCT04902716
- Acronym / sponsor ID
- 202102EM014
- Keywords
- Precision Nursing, Frail women, Cognitive function, Sleep quality, Emotional state
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 26 May 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Precision Nursing, Frail women, Cognitive function, Sleep quality, Emotional state, | Experimental | Behavioral: Design courseAccording 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. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (2 listed)
- -(1) Severe visual and hearing impairment, unable to cooperate with the researcher.
- Those whose limbs cannot participate in activities normally. (3) For chronic physical diseases, doctors have ordered those who are prohibited from exercising.
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 |
|---|---|---|
| Design coursePrecision 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. | Behavioural | Precision Nursing, Frail women, Cognitive function, Sleep quality, Emotional state, |
Primary outcome
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.
Pittsburgh Sleep Quality Index, PSQI
Time frame: 1 month
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.
BSRS-5 (5-item Brief Symptom Rating Scale)
Time frame: 1 week
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Results publication: PubMed 32099853Fu 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.
- Results publication: PubMed 31291884Kidd 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.
- Results publication: PubMed 29346524Romera-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.
- Results publication: PubMed 32357858Wang 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.
- Results publication: PubMed 28064173Puts 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.
- Individual participant dataSharing planned: No
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?
A study testing Design course in people with The Effectiveness of Precision Nursing Intervention Program on Cognitive Function、Sleep Quality and Emotional State of Frail Femal Elderly in the Community, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
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 1 inclusion and 2 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 26 May 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 Taiwan. 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?
Contact Jui-Wen Yu, Master (+886933264339, jwenyu0311@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Portable Mental State Questionnaire, SPMSQ (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04902716, which also lists 5 linked publications.
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 26 May 2021.