Promoting psychosocial wellbeing following stroke A randomized, single blind, controlled trial

Promoting psychosocial wellbeing following stroke A randomized, single blind, controlled trial Line Kildal Bragstad, OT, PhD, Postdoc, Oslo Universit...
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Promoting psychosocial wellbeing following stroke A randomized, single blind, controlled trial

Line Kildal Bragstad, OT, PhD, Postdoc, Oslo University Hospital Ellen Gabrielsen Hjelle, OT, PhD Candidate, University of Oslo 1st CHARM International Seminar, Oslo November 10th 2015

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)

Identifying evidence & theory

Review of literature

Qualitative review and synthesis

Development of initial intervention protocol Modeling process & outcomes

Critical review and consensus process involving stroke patients, relatives, clinical experts, health care leaders & researchers

Finalizing intervention protocol for exploratory trial Exploratory trial Initial testing

Assessment of intervention content, structure & process

Assessment of usability to patients & professionals

Assessment of methodological issues

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)

Initial testing

Assessment of intervention content, structure & process

Assessment of usability to patients & professionals

Assessment of methodological issues

Finalizing protocol for Randomized controlled trial

Randomized controlled trial Intervention group Evaluation

Control group

Assessing effectiveness of intervention

Assessment of intervention content, structure & process

Assessment of usability to patients & professionals

Assessment of methodological issues

A randomized, single blind, controlled trial • 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

Recruitment

T1 interview at 1 month

Randomization

Intervention group

Control group

5 month intervention

Regular follow up

T2 interview at 6 months

T2 interview at 6 months

T3 interview at 12 months

T3 interview at 12 months

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 5th 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 (Craig et al. 2008)

• 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

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)

A special thanks to recruitment personnel in the hospitals, interventionists and data collectors.

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