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StrokeNCT05501275

Evaluation of Life Quality in Post Stroke Patients

A study testing psychotherapy in people with Stroke and Quality of Life, run by Palacky University at 1 site in Czechia.

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

Despite numerous advances in diagnosing procedures, treatment and prevention, stroke is considered a significant cause of long-term disability in the adult population Quality of life, which is deteriorated in patients after stroke (CVA), especially in the first years after stroke, is not only affected by the disease… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Stroke, Quality of Life
What is being tested?
psychotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
447 participants
Where
1 siteCzechia
Study dates
14 Sep 2021to 30 Jun 2023
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 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult with a clinical diagnosis of CVA in his/her medical history, lasting at ≥ 6 months and ≤ 3 years since the primo-attack,
  • first hospitalized in a specialized medical institution,
  • partial self-sufficiency,
  • signed informed consent.

Who cannot join

  • non-cooperation,
  • recurrent CVA,
  • severe depression with BDI-II score ≥ 40,
  • dementia with MMSE score ≤ 25,
  • presence of cancer and/or the end-stage of the disease.

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • Palacky University

    Olomouc, 77900

Other trials in Czechia

About this study

Despite numerous advances in diagnosing procedures, treatment and prevention, stroke is considered a significant cause of long-term disability in the adult population Quality of life, which is deteriorated in patients after stroke (CVA), especially in the first years after stroke, is not only affected by the disease but is closely related to dignity and the satisfaction of human needs, including educational needs.

The term "Health-Related Quality of Life" (HRQoL) is used in the scientific literature as a criterion of change for medical purposes. It is an indicator of health service needs and a way to evaluate health status in a very efficient way. Psychoeducation can be applied in medical and nursing practice, as an intervention that can improve and/or maintain the quality of life, especially if it is provided to patients without a significant cognitive deficit. Psychoeducational programmes can be defined as didactic-therapeutic interventions that serve to provide information about the disease, emotional and social support and, last but not least, facilitate adaptation to new life situations.

Read the detailed description

Detailed description:

The influence of selected aspects on HRQoL will be statistically assessed in the initial phase of the research. At a later stage, the monitored file will be randomized, in a predefined 1:1 ratio.

The control group will be provided only with conventional treatment focused on neurorehabilitation care according to the workplace's habits, and structured psychoeducation will be added to this usual care. The group psychoeducational interview, which reflects the issue of CVA, will be conducted face-to-face by a clinical psychologist, a health and social worker and a nurse. It will be limited by a 6-week therapy session 1 time per week, lasting approximately 45 minutes.

Patients will be tested with 6 standardized questionnaires in the Czech language version initially before the start of treatment and subsequently one month post the completion date of their treatment. The EuroQol-5 (EQ-5D-5L) instrument will be used to assess HRQoL. The Patient Dignity Inventory (PDI) questionnaire has been chosen to identify problems related to problems associated with patient dignity. The Mini-Mental State Examination (MMSE) cognitive test will be used to indicatively detect dementia and the Beck Depression Inventory Second Edition (BDI-II) will be used to diagnose the severity of depressive symptoms. The Visual Analogue Scale (VAS) will be used to objectify the perception of pain and the Barthel Index (BI) for scoring ADL. At the same time, selected relevant clinical and anamnestic data will be extracted from the medical records.

Being tested
psychotherapy
Keywords
stroke, life quality, evaluation
Medical subject headings
Stroke

What participants receive

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

  • psychotherapyBehavioural

    Psychotherapy and psychoeducation in patients after stroke.

Study groups in NCT05501275
Study groupRoleWhat they receive
With PsychoeducationExperimentalinterventional group will receive psychoeducation.
Receives: Behavioral: psychotherapy
Basic Therapy OnlyNo interventionthis group will receive only basic therapy

What is being measured

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

  1. Change in the Health-Related Quality of Life (HRQoL) in patients after stroke

    Change in the Health-Related Quality of Life (HRQoL) [Time Frame: Baseline state (immediately prior to the rehabilitation facility admission) and follow-up monitoring (two and a half months after the rehabilitation facility admission)].

    Health-Related Quality of Life (HRQoL) is assessed using the European Quality of Life Questionnaire version 5, level 5 instrument. The output is an index (HRQoL dimension). Subsequently, the respondents are asked to indicate their subjectively perceived health condition.

    Measured: 3 months

Secondary outcomes (1)

  1. Change in patient´s dignity, level of depression, functional independence and pain

    Several scales were used:

    • to measure the patient´s dignity: Patient Dignity Inventory
    • to measure the level of depression: Beck Depression Inventory-II (BDI-II)
    • to measure the level of functional independence: Barthel Index (BI)
    • to measure the level of pain: visual analogue scale (VAS)

    Measured: before the intervence and after 3 months

Timeline

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

  1. First posted15 Aug 2022
  2. Study start14 Sep 2021
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2023

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
447 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05501275
Sponsor's protocol ID
PalackyU
Status last verified
Nov 2023
First submitted
21 Jul 2022
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hamid GM, MacKenzie MA. CE: Early Intervention in Patients with Poststroke Depression. Am J Nurs. 2017 Jul;117(7):32-40. doi: 10.1097/01.NAJ.0000520919.26724.9b.

    PubMed 28594643

  • Mavaddat N, Sadler E, Lim L, Williams K, Warburton E, Kinmonth AL, Mant J, Burt J, McKevitt C. Perceptions of self-rated health among stroke survivors: a qualitative study in the United Kingdom. BMC Geriatr. 2018 Apr 2;18(1):81. doi: 10.1186/s12877-018-0765-8.

    PubMed 29609550

  • Verberne DPJ, Kroese MEAL, Staals J, Ponds RWHM, van Heugten CM. Nurse-led stroke aftercare addressing long-term psychosocial outcome: a comparison to care-as-usual. Disabil Rehabil. 2022 Jun;44(12):2849-2857. doi: 10.1080/09638288.2020.1849417. Epub 2020 Nov 26.

    PubMed 33242261

  • Ostwald SK, Godwin KM, Cron SG, Kelley CP, Hersch G, Davis S. Home-based psychoeducational and mailed information programs for stroke-caregiving dyads post-discharge: a randomized trial. Disabil Rehabil. 2014;36(1):55-62. doi: 10.3109/09638288.2013.777806. Epub 2013 Apr 17.

    PubMed 23594060

  • Olukolade O, Osinowo HO. Efficacy of Cognitive Rehabilitation Therapy on Poststroke Depression among Survivors of First Stroke Attack in Ibadan, Nigeria. Behav Neurol. 2017;2017:4058124. doi: 10.1155/2017/4058124. Epub 2017 Jun 27.

    PubMed 28720980

  • Brouns B, van Bodegom-Vos L, de Kloet AJ, Tamminga SJ, Volker G, Berger MAM, Fiocco M, Goossens PH, Vliet Vlieland TPM, Meesters JJL. Effect of a comprehensive eRehabilitation intervention alongside conventional stroke rehabilitation on disability and health-related quality of life: A pre-post comparison. J Rehabil Med. 2021 Mar 5;53(3):jrm00161. doi: 10.2340/16501977-2785.

    PubMed 33369683

Questions about this trial

What is this clinical trial studying?

A study testing psychotherapy in people with Stroke and Quality of Life, run by Palacky University at 1 site in Czechia.

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 4 inclusion and 5 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 18 Nov 2023. 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 Czechia. 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 in the Health-Related Quality of Life (HRQoL) in patients after stroke (time frame: 3 months). 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 NCT05501275, which also lists 6 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 18 Nov 2023.

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