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Nursing CareNCT04384289

Nurse Led Transitional Care Model in Cardiac Surgery

A study testing Nursing care based on the Transitonal Care Model in people with Nursing Care and Quality of Life, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Nursing Care, Quality of Life, Transitional Care
What is being tested?
Nursing care based on the Transitonal Care Model
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Nov 2017to 15 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Bolu Abant Izzet Baysal University

    Bolu, Town Center, 14030

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Nurse Led Transitional Care Model on Elderly Patients Undergoing Open Heart Surgery: A Randomized Controlled Trial

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.

Being tested
Nursing care based on the Transitonal Care Model
Keywords
Transitional Care Model, heart surgery, nursing care, autonomy, quality of life, elderly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nursing care based on the Transitonal Care ModelProcedure or surgery

    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

Study groups in NCT04384289
Study groupRoleWhat they receive
''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.
Receives: Procedure: Nursing care based on the Transitonal Care Model

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (1)

  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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2020
  2. Study start15 Nov 2017
  3. Primary completion20 Nov 2017
  4. Study completion15 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled intervention study with a parallel group in a pretest-posttest design
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04384289
Sponsor's protocol ID
AIBU-KDC-SC01
Status last verified
May 2020
First submitted
5 Apr 2020
Last updated
12 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    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

Questions about this trial

What is this clinical trial studying?

A study testing Nursing care based on the Transitonal Care Model in people with Nursing Care and Quality of Life, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Baseline(up to 24 hours after the admission) and Week 9 after discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04384289, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.

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