Quality of Life Clinical Trial
Official title:
The Effects of Nurse Led Transitional Care Model on Elderly Patients Undergoing Open Heart Surgery: A Randomized Controlled Trial
Verified date | May 2020 |
Source | Abant Izzet Baysal University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the effectiveness of Nurse Led Transitional Care Model (TCM) on the functional autonomy, quality of life and rehospitalization rates of elderly patients undergoing open heart surgery.
Status | Completed |
Enrollment | 66 |
Est. completion date | December 15, 2018 |
Est. primary completion date | November 20, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - be hospitalized for the first time and for elective open heart surgery; - have no other surgical intervention other than an open heart surgery, - have no psychological and mental disorders, - have no major chronic problems such as kidney problems, neurological problems or cancer, - be able to speak Turkish, - be available to be communicated by phone, - provide consent to participate in the study, - live at a maximum distance of 50 km from the hospital (for easy access during post-discharge follow-up visits). Exclusion Criteria: - ask to leave the study, - be exposed to a disease or trauma that may affect his/her functional autonomy during the study, - die throughout the study |
Country | Name | City | State |
---|---|---|---|
Turkey | Bolu Abant Izzet Baysal University | Bolu | Town Center |
Lead Sponsor | Collaborator |
---|---|
Abant Izzet Baysal University |
Turkey,
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Naylor MD, Aiken LH, Kurtzman ET, Olds DM, Hirschman KB. The care span: The importance of transitional care in achieving health reform. Health Aff (Millwood). 2011 Apr;30(4):746-54. doi: 10.1377/hlthaff.2011.0041. Review. — View Citation
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Naylor MD, Hirschman KB, Hanlon AL, Bowles KH, Bradway C, McCauley KM, Pauly MV. Effects of alternative interventions among hospitalized, cognitively impaired older adults. J Comp Eff Res. 2016 May;5(3):259-72. doi: 10.2217/cer-2015-0009. Epub 2016 May 5. — View Citation
Sawatzky JA, Christie S, Singal RK. Exploring outcomes of a nurse practitioner-managed cardiac surgery follow-up intervention: a randomized trial. J Adv Nurs. 2013 Sep;69(9):2076-87. doi: 10.1111/jan.12075. Epub 2013 Jan 14. — View Citation
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Zhang P, Hu YD, Xing FM, Li CZ, Lan WF, Zhang XL. Effects of a nurse-led transitional care program on clinical outcomes, health-related knowledge, physical and mental health status among Chinese patients with coronary artery disease: A randomized controll — View Citation
Zhang P, Xing FM, Li CZ, Wang FL, Zhang XL. Effects of a nurse-led transitional care programme on readmission, self-efficacy to implement health-promoting behaviours, functional status and life quality among Chinese patients with coronary artery disease: — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Repeated admission and rehospitalization rates | The rate of repeated post discharge referrals to hospital and rehospitalization | Post discharge 2nd, 6th and 9th weeks and finally 6 months | |
Primary | Change from Baseline(up to 24 hours after the admission) in functional autonomy on the Functional Autonomy Measurement System (SMAF) at 9th week after discharge. | The Functional Autonomy Measurement System (SMAF) is a validated, self reported instrument assessing 25 functions of the individual including daily life activities, communication and mental functions. Possible scores range from 0 to -87. A total score below -5 obtained by the elderly person indicates that the patient is at the risk of losing his/her functional autonomy. Change = ( Week 9 after discharge score -Baseline score) | Baseline(up to 24 hours after the admission) and Week 9 after discharge | |
Secondary | Change from Baseline(up to 24 hours after the admission) inquality of life on the SF-36 Quality of Life Scale at 9th week after discharge. | The SF-36 Quality of Life Scale is a validated, self reported instrument consists of 36 items in total, assessing the health status in eight aspects namely; physical function (10 items), social function (2 items), role limitations due to physical problems (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy/vitality (4 items), pain (2 items) and overall health items (5 items). Each part of the scale is evaluated differently and hence does not have a total score that can be calculated. Change = ( Week 9 after discharge score -Baseline score). | Baseline(up to 24 hours after the admission) and Week 9 after discharge |
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