NCT01912014

Brief Summary

The purpose of this feasibility study is to develop and initially test a dialogue-based psychosocial intervention aimed at promoting coping and psychosocial wellbeing following an acute stroke. The intervention is carried out by primary care registered nurses or other appropriate health professionals. The intervention included persons with and without aphasia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_1

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

Study Start

First participant enrolled

January 1, 2007

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

4.2 years

First QC Date

July 24, 2013

Last Update Submit

July 29, 2013

Conditions

Keywords

strokepsychosocialinterventionquality of life

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Stroke and Aphasia Quality of Life (SAQOL-39)

    baseline and 2 weeks after end of intervention

Secondary Outcomes (1)

  • Change from baseline in Stroke and Aphasia Quality of Life (SAQOL-39)

    baseline and 12 months after end of intervention

Study Arms (1)

Psychosocial support and counselling

EXPERIMENTAL

There is only one arm as this is a pilot and feasibility study.

Behavioral: Psychosocial support and counselling

Interventions

Psychosocial support and counselling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old or above
  • acute stroke
  • weeks poststroke

You may not qualify if:

  • Other serious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University hospital

Oslo, Oslo County, Norway

Location

Related Publications (4)

  • Kirkevold M, Bronken BA, Martinsen R, Kvigne K. Promoting psychosocial well-being following a stroke: developing a theoretically and empirically sound complex intervention. Int J Nurs Stud. 2012 Apr;49(4):386-97. doi: 10.1016/j.ijnurstu.2011.10.006. Epub 2011 Nov 1.

    PMID: 22051438BACKGROUND
  • Bronken BA, Kirkevold M. Between the lines: generating good qualitative data in studies involving persons with aphasia. ANS Adv Nurs Sci. 2013 Apr-Jun;36(2):E14-28. doi: 10.1097/ANS.0b013e318290200a.

  • Bronken BA, Kirkevold M, Martinsen R, Wyller TB, Kvigne K. Psychosocial well-being in persons with aphasia participating in a nursing intervention after stroke. Nurs Res Pract. 2012;2012:568242. doi: 10.1155/2012/568242. Epub 2012 Jul 22.

  • Kirkevold M, Martinsen R, Bronken BA, Kvigne K. Promoting psychosocial wellbeing following stroke using narratives and guided self-determination: a feasibility study. BMC Psychol. 2014 Feb 3;2(1):4. doi: 10.1186/2050-7283-2-4. eCollection 2014.

MeSH Terms

Conditions

NarrationStroke

Interventions

Psychiatric RehabilitationCounseling

Condition Hierarchy (Ancestors)

CommunicationBehaviorCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health Services

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 24, 2013

First Posted

July 30, 2013

Study Start

January 1, 2007

Primary Completion

April 1, 2011

Study Completion

December 1, 2011

Last Updated

July 30, 2013

Record last verified: 2013-07

Locations