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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01972958
Other study ID # 200908042R
Secondary ID
Status Completed
Phase N/A
First received October 18, 2013
Last updated October 24, 2013
Start date March 2010
Est. completion date December 2010

Study information

Verified date October 2013
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial Summary

As the aging population increases, preventing and decreasing disabilities become a critical issue for the health care system. Previous researches have shown that preventive community-based nursing services for older adults could achieve important health benefits at a relatively low cost. However, many frail and pre-frail older adults living in communities cannot get enough attention from current health care system. The role and function of nurses should be expanded to provide more comprehensive family-oriented care to improve health outcomes of older adults in Taiwan. The objectives of this study are:

1. Understand the difficulties and solutions for nurses providing community-based services in order to expand their better role and function.

2. Develop a cultural sensitive community advanced nurse service model for Taiwan in health care system.

3. Explore the effectiveness of community health programs by nurses for frail or pre-frail older adults in community.

Focus groups and literature review will be used to achieve the first and second study objectives. A single centre randomized controlled trial will be used in this study to achieve the third study objective. Two hundred and twenty people aged 65 and over who meet the Fried definition of frailty and pre-frailty will be recruited from the clinic of a hospital. Participants will be followed for a 6-month period. Frailty, quality of life, satisfaction to the services, hospitalizations and admissions to nursing care facilities will be measured and compared between experimental group and control group. This research is an important step in the examination of a new approach to the community older people by nurses. The study results will provide the evidence data to recommendation for related policy making in the future.


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- 65 years and above, frail and pre-frail older adults, living in communities

Exclusion Criteria:

- Cognitive impairment.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Other:
comprehensive care
comprehensice assessment,physical activity training, community resources referral, health education.

Locations

Country Name City State
Taiwan School of Nursing, National Taiwan University Taipei

Sponsors (2)

Lead Sponsor Collaborator
National Taiwan University Hospital Department of Health, Executive Yuan, R.O.C. (Taiwan)

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess quality of life 6 months No
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