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CompletedNCT04384289Updated May 12, 2020

Nurse Led Transitional Care Model in Cardiac Surgery

An interventional study of Nursing care based on the Transitonal Care Model in Nursing Care, Quality of Life and Transitional Care, sponsored by Abant Izzet Baysal University. Completed at 1 site in Turkey. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-12.

Sponsored by Abant Izzet Baysal University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Nov 2017, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Nursing Care
  • Quality of Life
  • Transitional Care

Keywords

  • Transitional Care Model
  • heart surgery
  • nursing care
  • autonomy
  • quality of life
  • elderly
03

In context

Lead sponsor

Abant Izzet Baysal University is the lead sponsor of 242 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (actual)

Study arms

  • No intervention
    ''Standard Care''

    ''Standard Care'' group were given standard care services.

  • Experimental
    "Transitional Care Model"

    "Transitional Care Model" group were given care based on the Transitional Care Model until the post discharge 9th week starting from date of hospitalization.

    Procedure: Nursing care based on the Transitonal Care Model

Interventions

  • ProcedureNursing 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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Baseline(up to 24 hours after the admission) and Week 9 after discharge

Secondary outcomes

  1. 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).

    Time frame: Baseline(up to 24 hours after the admission) and Week 9 after discharge

Other outcomes

  1. Repeated admission and rehospitalization rates

    The rate of repeated post discharge referrals to hospital and rehospitalization

    Time frame: Post discharge 2nd, 6th and 9th weeks and finally 6 months

07

Study locations

1 site
  • Bolu Abant Izzet Baysal University
    Bolu, Town Center 14030, Turkey
08

References and documents

Publications

  • 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. PubMed 27146416 ↗
  • 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. PubMed 21471497 ↗
  • 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: A randomised controlled trial. J Clin Nurs. 2018 Mar;27(5-6):969-979. doi: 10.1111/jocn.14064. Epub 2018 Jan 8. PubMed 28880419 ↗
  • 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 controlled trial. Int J Nurs Stud. 2017 Sep;74:34-43. doi: 10.1016/j.ijnurstu.2017.04.004. Epub 2017 Apr 14. PubMed 28601691 ↗
  • 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. PubMed 25470529 ↗
  • 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. PubMed 23317314 ↗
  • 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. doi: 10.1111/j.1532-5415.2004.52202.x. Erratum In: J Am Geriatr Soc. 2004 Jul;52(7):1228. PubMed 15086645 ↗
  • 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. PubMed 20367721 ↗
  • 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. PubMed 24969152 ↗
  • Lie I, Danielsen SO, Tonnessen T, Solheim S, Leegaard M, Sandvik L, Wisloff T, Vangen J, Rosstad TH, Moons P. Determining the impact of 24/7 phone support on hospital readmissions after aortic valve replacement surgery (the AVRre study): study protocol for a randomised controlled trial. Trials. 2017 May 30;18(1):246. doi: 10.1186/s13063-017-1971-y. PubMed 28693599 ↗
  • Coskun S, Duygulu S. The effects of Nurse Led Transitional Care Model on elderly patients undergoing open heart surgery: a randomized controlled trial. Eur J Cardiovasc Nurs. 2022 Jan 11;21(1):46-55. doi: 10.1093/eurjcn/zvab005. PubMed 33821999 ↗

Study documents

  • Protocol and statistical analysis plan · May 25, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04384289
Lead sponsor
Abant Izzet Baysal University
Responsible party
Sponsor
First posted
May 12, 2020
Start date
Nov 15, 2017
Primary completion
Nov 20, 2017
Completion
Dec 15, 2018
Last update
May 12, 2020

Study contacts

SERGÜL DUYGULU, Assoc. Prof
study director · the advisor of this doctoral thesis study

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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