NCT03500250

Brief Summary

Rationale: Depression is a frequent complication after a stroke. In stroke guidelines several recommendations focus on early screening, and treatment off depression after stroke. Introducing clinical practice guidelines into routine daily practice however, is a difficult process. In order to make the recommendations applicable to clinical practice a toolkit was developed (the Post Stroke Depression-toolkit), which provides assessment tools for the early detection of depression after stroke, and a set of interventions in case of a positive screening for (risk on) depressive symptoms. Objective: to investigate the feasibility of the Post Stroke Depression-toolkit in daily practice. Study design: An explanatory mixed-methods, before-and-after study design. Study population: Nurses working on the neurological wards of one university hospital and two general hospitals in the Netherlands were included in the study. Additionally, data were obtained from patient charts.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2012

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

Study Start

First participant enrolled

April 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2013

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

April 9, 2018

Last Update Submit

April 9, 2018

Conditions

Keywords

Complex interventionDepressionNursingStrokeFeasibility

Outcome Measures

Primary Outcomes (2)

  • Fidelity

    the extent to which the components of the PSD toolkit are delivered as intended

    12 months

  • Acceptability

    whether the PSD toolkit is judged suitable and satisfactory by the nurses

    T=0; T=1 (after 6 months); T=2 (after 12 months)

Study Arms (1)

Nurses

Nurses working on the neurological wards of three hospitals (one university hospital and two general hospitals)

Other: Post-Stroke Depression toolkit

Interventions

The Post-Stroke Depression toolkit consists of three components: (1) two screening instruments, (2) seven evidence-based nursing interventions, and (3) an instruction manual.

Nurses

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All nurses working on the neurological wards and stroke units of the participating hospitals, one university hospital and two general hospitals.

You may qualify if:

  • Registered Nurses with or without Bachelor degree in Nursing (BN); Nursing students.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (19)

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    PMID: 23159157BACKGROUND
  • Research design: qualitative, quantitative and mixed methods approaches Research design: qualitative, quantitative and mixed methods approaches Creswell John W Sage 320 pound29 0761924426 0761924426 [Formula: see text]. Nurse Res. 2004 Sep 1;12(1):82-83. doi: 10.7748/nr.12.1.82.s2.

    PMID: 28718745BACKGROUND
  • de Man-van Ginkel JM, Gooskens F, Schepers VP, Schuurmans MJ, Lindeman E, Hafsteinsdottir TB. Screening for poststroke depression using the patient health questionnaire. Nurs Res. 2012 Sep-Oct;61(5):333-41. doi: 10.1097/NNR.0b013e31825d9e9e.

    PMID: 22710475BACKGROUND
  • Gearing RE, El-Bassel N, Ghesquiere A, Baldwin S, Gillies J, Ngeow E. Major ingredients of fidelity: a review and scientific guide to improving quality of intervention research implementation. Clin Psychol Rev. 2011 Feb;31(1):79-88. doi: 10.1016/j.cpr.2010.09.007. Epub 2010 Oct 7.

    PMID: 21130938BACKGROUND
  • McCluskey A, Middleton S. Delivering an evidence-based outdoor journey intervention to people with stroke: barriers and enablers experienced by community rehabilitation teams. BMC Health Serv Res. 2010 Jan 19;10:18. doi: 10.1186/1472-6963-10-18.

    PMID: 20082725BACKGROUND
  • Peters M., Harmsen M., Laurant M. & Wensing M. (2002) Barriers to and facilitators for improvement of patient care. Nijmegen: Centre for Quality of Care Research (WOK), Radboud University Nijmegen Medical Centre, the Netherlands.

    BACKGROUND
  • Polit, D. F., & Beck, C. T. (2008). Nursing research: Generating and assessing evidence for nursing practice Lippincott Williams & Wilkins.

    BACKGROUND
  • Scheirer, M. A. (2005). Is sustainability possible? A review and commentary on empirical studies of program sustainability. American Journal of Evaluation 26(3), 320-347.

    BACKGROUND
  • van Achterberg T, Schoonhoven L, Grol R. Nursing implementation science: how evidence-based nursing requires evidence-based implementation. J Nurs Scholarsh. 2008;40(4):302-10. doi: 10.1111/j.1547-5069.2008.00243.x.

    PMID: 19094144BACKGROUND
  • Harris MR, Warren JJ. Patient outcomes: assessment issues for the CNS. Clin Nurse Spec. 1995 Mar;9(2):82-6.

    PMID: 7600487BACKGROUND
  • Miller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, Billinger SA; American Heart Association Council on Cardiovascular Nursing and the Stroke Council. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010 Oct;41(10):2402-48. doi: 10.1161/STR.0b013e3181e7512b. Epub 2010 Sep 2. No abstract available.

    PMID: 20813995BACKGROUND
  • Johnson W, Onuma O, Owolabi M, Sachdev S. Stroke: a global response is needed. Bull World Health Organ. 2016 Sep 1;94(9):634-634A. doi: 10.2471/BLT.16.181636. No abstract available.

    PMID: 27708464BACKGROUND
  • Kutlubaev MA, Hackett ML. Part II: predictors of depression after stroke and impact of depression on stroke outcome: an updated systematic review of observational studies. Int J Stroke. 2014 Dec;9(8):1026-36. doi: 10.1111/ijs.12356. Epub 2014 Aug 26.

    PMID: 25156411BACKGROUND
  • Robinson RG, Jorge RE. Post-Stroke Depression: A Review. Am J Psychiatry. 2016 Mar 1;173(3):221-31. doi: 10.1176/appi.ajp.2015.15030363. Epub 2015 Dec 18.

    PMID: 26684921BACKGROUND
  • Hart S, Morris R. Screening for depression after stroke: an exploration of professionals' compliance with guidelines. Clin Rehabil. 2008 Jan;22(1):60-70. doi: 10.1177/0269215507079841. Epub 2007 Nov 29.

    PMID: 18048484BACKGROUND
  • Bowen A, Knapp P, Hoffman A, Lowe D. Psychological services for people with stroke: compliance with the U.K. National Clinical Guidelines. Clin Rehabil. 2005 May;19(3):323-30. doi: 10.1191/0269215505cr799oa.

    PMID: 15859533BACKGROUND
  • Hafsteinsdottir TB, Varekamp R, Rensink M, van Linge R, Lindeman E, Schuurmans M; Rehabilitation Guideline Stroke Working Group. Feasibility of a nursing rehabilitation guideline for patients with stroke: evaluating the use by nurses. Disabil Rehabil. 2013 Jun;35(11):939-49. doi: 10.3109/09638288.2012.721049. Epub 2012 Oct 5.

    PMID: 23035834BACKGROUND
  • Hafsteinsdóttir TB, Schuurmans MM. Clinical Nursing Rehabilitation Stroke-Guideline [in Dutch: Verpleegkundige Revalidatierichtlijn Beroerte. Maarsen: Elsevier Gezondheidszorg; 2009. Available from: http://www.elseviergezondheidszorg.nl

    BACKGROUND
  • Van Dijk MJ, Hafsteinsdottir TB, Schuurmans MJ, de Man-van Ginkel JM. Feasibility of a nurse-led intervention for the early management of depression after stroke in hospital. J Adv Nurs. 2018 Dec;74(12):2882-2893. doi: 10.1111/jan.13806. Epub 2018 Aug 29.

MeSH Terms

Conditions

DepressionStroke

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 9, 2018

First Posted

April 18, 2018

Study Start

April 1, 2012

Primary Completion

June 30, 2013

Study Completion

June 30, 2013

Last Updated

April 18, 2018

Record last verified: 2018-04