Developing and Validating Digital Affective Patient Experience/Outcome Measure

Pregnancy Related Clinical Trial

— ETVa  

Official title:

Developing and Validating Digital Affective Patient Experience/Outcome Measure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03337321
• Other study ID #: 2329/2016
• Status: Active, not recruiting
• Start date: January 13, 2018
• Est. completion date: December 2020

Study information

• Verified date: April 2020
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the research project is to develop and validate a new digital measure of affective patient experience in maternal care. In this validating study extensive collection of affective ratings of 195 emotion words is collected. Pregnant women at different gestational stages are asked to provide affective ratings of 195 emotion words in relation to the dimensions: pleasure, arousal, dominance. Based on these ratings population averages and properties of emotion words will be calculated. The measure will be developed in respect to the analysis of affective rating and supplementing data.

Description:

As there is an increasing demand for and interest in measures that take patient's emotions into account, this research project aims to develop and validate a new digital measure of affective patient-reported experience/outcome in maternal care.

In this validating study extensive collection of affective ratings of 195 emotion words will be collected. Pregnant women (N=1000) at different gestational stages are asked to provide affective ratings of 195 emotion words in relation to the dimensions: pleasure, arousal, dominance. This is done by using a visual Likert scale (Self-Assessment Manikin). The pregnant women participating in the research are also asked to answer to various questionnaires to identify patterns of personality, behavior and the state of health and well-being. Based on the affective ratings population averages and properties of emotion words will be calculated. The measure will be developed in respect to the analysis of affective ratings and supplementing data.

The research provides insights on how affective ratings could be connected to clinical indicators and patient experience.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: December 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• ongoing pregnancy

• attending maternal care in the Hospital District of Helsinki and Uusimaa

• fluent in Finnish

• access to mobile communication device

Exclusion Criteria: none

Related Conditions & MeSH terms

• Affective; Reaction
• Pregnancy Related
• Validation Studies

Locations

Country	Name	City	State
Finland	The Hospital District of Helsinki and Uusimaa	Helsinki	Uusimaa

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Aalto University

Country where clinical trial is conducted

Finland, 

References & Publications (9)

Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, Ader D, Fries JF, Bruce B, Rose M; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007 May;45(5 Suppl 1):S3-S11. — View Citation

Konstabel, K., Lönnqvist, J.-E., Walkowitz, G., Konstabel, K. and Verkasalo, M. (2012), The 'Short Five' (S5): Measuring personality traits using comprehensive single items. European Journal of Personality, 26(1), 13-29. doi:10.1002/per.813

Lang, P. J. (1980). Behavioral treatment and bio-behavioral assessment: computer applications. In J. B. Sidowski, J. H. Johnson, & T. A. Williams (Eds.), Technology in mental health care delivery systems (pp. 119-l37). Norwood, NJ: Ablex.

Larsson G, Wilde-Larsson B. Quality of care and patient satisfaction: a new theoretical and methodological approach. Int J Health Care Qual Assur. 2010;23(2):228-47. — View Citation

Lee H, Vlaev I, King D, Mayer E, Darzi A, Dolan P. Subjective well-being and the measurement of quality in healthcare. Soc Sci Med. 2013 Dec;99:27-34. doi: 10.1016/j.socscimed.2013.09.027. Epub 2013 Oct 8. — View Citation

Mayer, J., & Stevens, A. (1994). An emerging understanding of the reflective (meta-) experience of mood. Journal of Research in Personality, 28, 351-373.

Salovey, P., Mayer, J. D., Goldman, S. L., Turvey, C., and Palfai, T. P. (1995). Emotional attention, clarity, and repair: Exploring emotional intelligence using the Trait Meta-Mood Scale. In J. W. Pennebaker (Ed.), Emotion, Disclosure and Health (pp.125-151). Washington, DC: American Psychological Association.

Sjetne IS, Iversen HH, Kjøllesdal JG. A questionnaire to measure women's experiences with pregnancy, birth and postnatal care: instrument development and assessment following a national survey in Norway. BMC Pregnancy Childbirth. 2015 Aug 21;15:182. doi: 10.1186/s12884-015-0611-3. — View Citation

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	S5 personality traits (30 facets of the Five-Factor Model)	Short Five S5, a 60-item questionnaire (Konstabel et al 2012), is used to measure personality traits, more specifically, the 30 facets of the Five-Factor Model, using comprehensive single items (CSI).	9 months
Other	emotion regulation	State and Trait meta-mood questionnaire (adapted from: Mayer & Stevens 1994; Salovey et al 1995)	9 months
Other	health related quality of life	PROMIS-10 (Cella et al 2007)	9 months
Other	emotional stress reaction	Emotional Stress Reaction Questionnaire (ESRQ) (Larsson&Wilde-Larsson 2010)	9 months
Other	subjective well-being	Subjective Well-Being Questionnaire (SWB) (Lee et al 2013)	9 months
Other	patient experience in maternal care	Pregnancy- and maternity-care patients' experiences questionnaire (PreMaPeq) (Sjetne et al 2015)	9 months
Primary	three-dimensional affective ratings	affective rating of 195 emotion words in relation to pleasure, arousal, dominance (Lang 1980)	9 months
Secondary	anxiety	Generalized Anxiety Disorder Scale (GAD-7) (Spitzer et al. 2006). Scale is from 0 to 21. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.	9 months

External Links

•   Maternity services of Helsinki and Uusimaa Hospital District (HUS), Finland
•   The Institute of Healthcare Engineering, Management and Architecture (the HEMA Institute) at Aalto University School of Science, Finland