Line Kildal Bragstad, OT, PhD, Postdoc, Oslo University Hospital Ellen Gabrielsen Hjelle, OT, PhD Candidate, University of Oslo
Promoting psychosocial wellbeing following stroke A randomized, single blind,
controlled trial
1
stCHARM International Seminar, Oslo November 10
th2015
Presentation outline
• Background
• Development of study and intervention
• The intervention
– Presentation of worksheets
• Methods
– RCT design – Evaluation
• Status and experiences after 1 year of
recruitment
Psychosocial problems following stroke
• Prevalent symptoms:
– Depression – Anxiety
– Emotional instability – Social isolation
– Aphasia
(Hackett et. al. 2008a,b; Campbell Burton et. al. 2013;
Ferro et. al. 2009; Barker-Collo 2009; Kouwenhoven et. al.
2011; Engelter et. al. 2006)
Colourbox.com
Psychosocial problems following stroke
• Impact on:
– functional level – quality of life – survival
• Common challenges:
– give up leisure activities
– have difficulties returning to work
(Hackett et. al. 2008a,b; Redfern et al. 2006; Teoh et. al. 2009; Northcott & Hilari 2011; Martinsen et. al. 2013 ; Ferro et. al. 2009; Kouwenhoven et. al. 2011)
Existing interventions
• Interventions targeting information,
emotional support, practical advice, and motivational support
• Unclear how the different elements contribute to positive outcomes
• Few effective psychosocial interventions exist
(Hackett et. al. 2008a,b; Knapp et. al. 2000; Redfern et al. 2006; Smith et.
al. 2008; Ellis et. al. 2010; Lund 2012)
UK MRC framework for developing and evaluating complex
interventions
(Craig et al. 2008)
UK MRC framework for developing and evaluating complex
interventions
(Craig et al. 2008)
Qualitative review and synthesis Review of
literature
Development of initial intervention protocol
Critical review and consensus process involving stroke patients, relatives, clinical experts, health care leaders &
researchers
Finalizing intervention protocol for exploratory trial Exploratory trial
Modeling process &
outcomes
Initial
testing Assessment of
intervention content, structure & process
Assessment of usability to patients
& professionals
Assessment of methodological issues
Identifying evidence &
theory
Theoretical assumptions
• Health and wellbeing defined as a sense of coherence:
Life experiences are comprehensible, manageable & meaningful (Antonovsky)
• Quality of life defined as psychosocial wellbeing –A basic sense of contentment
–Meaningful activities
–Close and reciprocal relations
–A positive self concept, self acceptance, usefulness and belief in one’s own abilities (Næss)
• Story telling – narrative psychology
–A basic human approach to create meaning and coherence in experiences (Polkinghorne, Mattingly, Frank)
• Guided self determination - a method to support empowerment and coping (Zoffmann)
• Supported dialogues for adults with aphasia (Kagan)
The intervention
• 8 individual 1 hour meetings between stroke survivor and health care professional
• For each meeting, worksheets addressing psychosocial aspects are developed
• Worksheets and communication is adjusted to persons
with aphasia
Introduction
What happened?
What is important for you?
Bodily changes after stroke
Everyday life and emotions
Problem solving, activities of daily
life and social relationships
Living with the stroke
Coping and balancing activities
Final meeting of the intervention
• Summarize the meetings and progress
– How far in the rehabilitation have they come?
– How does the future look?
– What and who is important to them to continue progress?
– How is life going to be?
Look at worksheets that have been important in
the meetings
UK MRC framework for developing and evaluating complex
interventions
(Craig et al. 2008)
Exploratory trial
Initial
testing Assessment of
intervention content, structure & process
Assessment of
usability to patients &
professionals
Assessment of methodological issues
Randomized controlled trial
Evaluation
Assessment of
intervention content, structure & process
Assessment of
usability to patients &
professionals
Assessment of methodological issues
Intervention group Control group Finalizing protocol for Randomized controlled trial
Assessing effectiveness of intervention
Recruitment
T1 interview at 1 month
Randomization
Intervention group
5 month intervention
T2 interview at 6 months
T3 interview at 12 months
Control group
Regular follow up
T2 interview at 6 months
T3 interview at 12 months
• Power calculation based on GHQ-28
• 400 patients
– 200 intervention – 200 control
• Inclusion criteria
• Blinded data collection:
– T1: 1 month post stroke – T2: 6 months post stroke – T3: 12 months post stroke
A randomized, single
blind, controlled trial
Assessing effectiveness
Instrument Type of variable Data
collection
General Health Questionnaire (GHQ-28) Primary outcome T1, T2, T3
Stroke and Aphasia Quality of Life scale (SAQOL)
Secondary
outcome T1, T2, T3
Sense of Coherence (SOC-13) Secondary/inter
mediate T1, T2, T3
Ullevål Aphasia Screening (UAS) Characteristics
of sample T1
The Yale Brown single item questionnaire (Yale)
Characteristics
of sample T1, T2, T3
Lee’s fatigue scale (Lee 5) Characteristics
of sample T1, T2, T3
Fatigue Questionnaire-2 (FQ-2) Characteristics
of sample T1, T2, T3
Status of RCT (as of Nov 5 th 2015)
9 hospitals recruiting participants:
•180 participants enrolled
• 31 drop-outs
•149 active participants
– 68 interventions
• 8 participants not yet randomized
– Data collection at T3 recently started
Evaluation
• Assessing effectiveness
– RCT currently in process of recruitment
• Designing strategy to evaluate intervention
1. Participants from the intervention group
• Individual qualitative interviews
2. Health care personnel delivering the intervention
• Focus group interviews
• Field notes
3. Analysis of drop-outs
(Craig et al. 2008)
Experiences so far…
• Time frame for recruitment
• Attrition rate (drop outs)
– Drop outs from the control group
– Drop outs from the intervention group – Natural causes
• Positive feedback from intervention
participants
Research team
• Marit Kirkevold (PI) (RN, professor nursing), University of Oslo (UiO)
• Unni Sveen (co-PI) (OT, professor), Oslo University Hospital (OUS)/Oslo University College of Applied Sciences (HIOA)
• Line Kildal Bragstad (OT, PhD), Postdoc, OUS/UiO
• Ellen Gabrielsen Hjelle (OT), PhD Candidate, UiO
• Berit Bronken (RN, PhD), Hedmark University College
• Randi Martinsen (RN, Phd), Hedmark University College
• Kari Kvigne (RN, professor nursing), Hedmark University College
• Margrete Mangset (RN, PhD), researcher, OUS
• Siren Eriksen (RN, PhD), Editor/researcher, Norwegian National Advisory Unit on Ageing and Health (Ageing and Health)
• Torgeir Bruun Wyller (MD, professor geriatrics), OUS/UiO
• Gabriele Kitzmüller (RN, PhD), Narvik University College
• Dag Hofoss, Political science, Epidemiologist/statistician, Professor, UiO
• Karianne Berg, NTNU & Line Haaland, Speech therapists, Bredtvedt Kompetansesenter
• Katerina Hilari (Psychologist/Assoc. Prof. City University)
• Liz Lightbody (RN, Senior researcher, University of Central Lancashire)
