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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04384289
Other study ID # AIBU-KDC-SC01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2017
Est. completion date December 15, 2018

Study information

Verified date May 2020
Source Abant Izzet Baysal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Rate and number of successful cases in open heart surgery has been increasing due to the advances in medical technology and surgery. To improve patient convalescence results and reduce rate of post-discharge readmission to hospital and unplanned post-discharge rehospitalization, home-care and follow-up process of patients should be managed successfully.

A total of 66 elderly patients who agreed to participate in the study between November 2017 and December 2018 were randomly assigned to the intervention (n: 33) and control (n: 33) groups. Patients in intervention group were given care based on the TCM until the post discharge 9th week starting from date of hospitalization. Patients in control group were given standard care services. Functional autonomy and quality of life levels of patients were evaluated at admission to the clinic and at the post-discharge 9th week whereas their repeated admission rates to the clinic and re-hospitalization rates were evaluated at post discharge 2nd, 6th and 9th weeks and finally 6 months. The CONSORT checklist was used to check the procedure.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Nursing care based on the Transitonal Care Model
Nursing care carried out in collaboration with a multidisciplinary team in line with Transitonal Care Model for elderly patients who have undergone open heart surgery

Locations

Country Name City State
Turkey Bolu Abant Izzet Baysal University Bolu Town Center

Sponsors (1)

Lead Sponsor Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

Lie I, Danielsen SO, Tønnessen T, Solheim S, Leegaard M, Sandvik L, Wisløff T, Vangen J, Røsstad TH, Moons P. Determining the impact of 24/7 phone support on hospital readmissions after aortic valve replacement surgery (the AVRre study): study protocol fo — View Citation

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

Naylor MD, Brooten DA, Campbell RL, Maislin G, McCauley KM, Schwartz JS. Transitional care of older adults hospitalized with heart failure: a randomized, controlled trial. J Am Geriatr Soc. 2004 May;52(5):675-84. Erratum in: J Am Geriatr Soc. 2004 Jul;52( — View Citation

Naylor MD, Feldman PH, Keating S, Koren MJ, Kurtzman ET, Maccoy MC, Krakauer R. Translating research into practice: transitional care for older adults. J Eval Clin Pract. 2009 Dec;15(6):1164-70. doi: 10.1111/j.1365-2753.2009.01308.x. — View Citation

Naylor MD, Hirschman KB, Hanlon AL, Bowles KH, Bradway C, McCauley KM, Pauly MV. Comparison of evidence-based interventions on outcomes of hospitalized, cognitively impaired older adults. J Comp Eff Res. 2014 May;3(3):245-57. doi: 10.2217/cer.14.14. — View Citation

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

Wong FK, Yeung SM. Effects of a 4-week transitional care programme for discharged stroke survivors in Hong Kong: a randomised controlled trial. Health Soc Care Community. 2015 Nov;23(6):619-31. doi: 10.1111/hsc.12177. Epub 2014 Dec 3. — View Citation

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

Outcome

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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