Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Nov 2017

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

Study Start

First participant enrolled

November 15, 2017

Completed

5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2017

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2018

Completed

1.3 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2020

Completed

1 month until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed

Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

5 days

First QC Date

April 5, 2020

Last Update Submit

May 11, 2020

Conditions

Nursing Care Quality of Life Transitional Care

Keywords

Transitional Care Modelheart surgerynursing careautonomyquality of lifeelderly

Outcome Measures

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)
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.
Baseline(up to 24 hours after the admission) and Week 9 after discharge

Other Outcomes (1)

Repeated admission and rehospitalization rates
Post discharge 2nd, 6th and 9th weeks and finally 6 months

Study Arms (2)

''Standard Care''

NO INTERVENTION

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

"Transitional Care Model"

EXPERIMENTAL

"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

Nursing care based on the Transitonal Care ModelPROCEDURE

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

"Transitional Care Model"

Eligibility Criteria

Age60 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Abant Izzet Baysal Universitylead

Study Sites (1)

Bolu Abant Izzet Baysal University

Bolu, Town Center, 14030, Turkey (Türkiye)

Location

Related Publications (11)

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.
PMID: 27146416BACKGROUND
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.
PMID: 21471497BACKGROUND
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.
PMID: 28880419RESULT
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.
PMID: 28601691RESULT
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.
PMID: 25470529RESULT
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.
PMID: 23317314RESULT
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.
PMID: 15086645RESULT
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.
PMID: 20367721RESULT
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.
PMID: 24969152RESULT
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.
PMID: 28693599RESULT
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.
PMID: 33821999DERIVED

Study Officials

SERGÜL DUYGULU, Assoc. Prof
the advisor of this doctoral thesis study
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: HEALTH SERVICES RESEARCH
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 5, 2020

First Posted

May 12, 2020

Study Start

November 15, 2017

Primary Completion

November 20, 2017

Study Completion

December 15, 2018

Last Updated

May 12, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing: Will not share

Locations

TU(1)

Nurse Led Transitional Care Model in Cardiac Surgery

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

''Standard Care''

"Transitional Care Model"

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (11)

Related Links

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

''Standard Care''

"Transitional Care Model"

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (11)

Related Links

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations