The Health Promoting Conversations for Families With a Critically Ill Relative
NCT ID: NCT03325049
Last Updated: 2021-02-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
17 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-09-01
Study Completion Date
2020-01-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Objective: We investigated the outcomes of a nurse-led family intervention, Health Promoting Conversations, which focused on family functioning and wellbeing in families with a critically ill member.
Study design: This randomized controlled pilot study used a pre-test, post-test design with intervention and control groups to investigate the outcomes of the nurse-led intervention in 17 families.
Outcome measures: The Health Promoting Conversations intervention was evaluated using validated instruments that measure family functioning and family wellbeing: the General Functioning sub-scale from the McMaster Family Assessment Device; the Family Sense of Coherence, the Herth Hope Index, and the Medical Outcome Short-Form Health Survey. Descriptive and analytical statistical methods were used to analyse the data.
Study design: This randomized controlled pilot study used a pre-test, post-test design with intervention and control groups to investigate the outcomes of the nurse-led intervention in 17 families.
Outcome measures: The Health Promoting Conversations intervention was evaluated using validated instruments that measure family functioning and family wellbeing: the General Functioning sub-scale from the McMaster Family Assessment Device; the Family Sense of Coherence, the Herth Hope Index, and the Medical Outcome Short-Form Health Survey. Descriptive and analytical statistical methods were used to analyse the data.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
FAM-SOTC Intervention for Families of Children With Chronic Illnesses
NCT03901027
Chronic Illnesses
COMPLETED
NA
Family Functioning and Child Behavior When a Sibling is Critically Ill
NCT00912626
Child Behavior
COMPLETED
NA
Health Promotion in Early Adolescence: Sleep, Activity, and Emotion Regulation
NCT01289197
Sleep Disorders
Physical Activity
Depression
+1 more
COMPLETED
NA
An Online Intervention to Reduce Self-Harm Among Persons With High Emotion-Related Impulsivity
NCT04781166
Suicidal Ideation
Deliberate Self-harm
Impulsivity
TERMINATED
NA
Dialectical Behavioral Therapy in High Risk OrthopaedicTrauma Patients
NCT03776929
Fracture
Surgery
WITHDRAWN
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This randomized control trial (RCT) used a pre-test, post-test design with intervention and control groups.
In the intervention group, there were 3 health-promoting conversations with each family after the discharge. The health-promoting conversations were held within an approximately 4- to 8-week period with an interval of 2 weeks between conversations. A closing letter was sent 2 to 3 weeks after the final conversation that summarized all of the conversations and that provided further opportunities for reflection.
Baseline data were collected to assess family functioning and wellbeing in the intervention group and the control group 1-2 months after the critical illness and before the start of the intervention. Follow-up assessments were conducted 3 and 12 months after the intervention for both groups. Additionally, background data, including health history, were collected using a self-administered questionnaire that asked about age; sex; education level; habits like smoking, alcohol consumption, and physical activity; psychosocial support; co-morbidity; and risk of mortality. The latter was calculated using the Charlson Comorbidity Index (Charlson et al., 1987).
The main outcome variables in this study were family functioning and family wellbeing. The following instruments were used in this study: 1) General Functioning (GF) sub-scale from the McMaster Family Assessment Device (FAD); 2) Family Sense of Coherence (F-SOC/F-KASAM); 3) Herth Hope Index (HHI); and 4) Medical Outcome Short-Form health survey (SF-36).
In the intervention group, there were 3 health-promoting conversations with each family after the discharge. The health-promoting conversations were held within an approximately 4- to 8-week period with an interval of 2 weeks between conversations. A closing letter was sent 2 to 3 weeks after the final conversation that summarized all of the conversations and that provided further opportunities for reflection.
Baseline data were collected to assess family functioning and wellbeing in the intervention group and the control group 1-2 months after the critical illness and before the start of the intervention. Follow-up assessments were conducted 3 and 12 months after the intervention for both groups. Additionally, background data, including health history, were collected using a self-administered questionnaire that asked about age; sex; education level; habits like smoking, alcohol consumption, and physical activity; psychosocial support; co-morbidity; and risk of mortality. The latter was calculated using the Charlson Comorbidity Index (Charlson et al., 1987).
The main outcome variables in this study were family functioning and family wellbeing. The following instruments were used in this study: 1) General Functioning (GF) sub-scale from the McMaster Family Assessment Device (FAD); 2) Family Sense of Coherence (F-SOC/F-KASAM); 3) Herth Hope Index (HHI); and 4) Medical Outcome Short-Form health survey (SF-36).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Family Health
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
This randomized controlled pilot study used a pre-test, post-test design with intervention and control groups
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
The health-promoting conversations
In the intervention group, there were 3 health-promoting conversations with each family after the discharge. The health-promoting conversations were held within an approximately 4- to 8-week period with an interval of 2 weeks between conversations. A closing letter was sent 2 to 3 weeks after the final conversation that summarized all of the conversations and that provided further opportunities for reflection.
Group Type
EXPERIMENTAL
The health-promoting conversations
Intervention Type
BEHAVIORAL
The health-promoting conversations
Control Arm
Usual Care
Group Type
ACTIVE_COMPARATOR
Usual Care
Intervention Type
OTHER
Usual Care
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
The health-promoting conversations
The health-promoting conversations
Intervention Type
BEHAVIORAL
Usual Care
Usual Care
Intervention Type
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* patient age \>18 years
* patient treated in the ICU for at least 96 hours
* at least one family member (age \>15 years) interested in participating
* patient treated in the ICU for at least 96 hours
* at least one family member (age \>15 years) interested in participating
Exclusion Criteria
* dementia
* or other severe psychiatric illnesses
* drug abuse
* difficulties in understanding or reading the Swedish language
* or other severe psychiatric illnesses
* drug abuse
* difficulties in understanding or reading the Swedish language
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Linkoeping University
OTHER_GOV
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Susanna Ågren
Head of the project
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Susanna Ågren, PhD
Role: PRINCIPAL_INVESTIGATOR
Linkoeping University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Linköping university
Linköping, , Sweden
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Sweden
References
Explore related publications, articles, or registry entries linked to this study.
Ahlberg M, Backman C, Jones C, Walther S, Hollman Frisman G. Moving on in life after intensive care--partners' experience of group communication. Nurs Crit Care. 2015 Sep;20(5):256-63. doi: 10.1111/nicc.12192. Epub 2015 May 29.
Reference Type
BACKGROUND
Alderfer MA, Fiese BH, Gold JI, Cutuli JJ, Holmbeck GN, Goldbeck L, Chambers CT, Abad M, Spetter D, Patterson J. Evidence-based assessment in pediatric psychology: family measures. J Pediatr Psychol. 2008 Oct;33(9):1046-61; discussion 1062-4. doi: 10.1093/jpepsy/jsm083. Epub 2007 Sep 28.
Reference Type
BACKGROUND
Antonovsky, A., Sourani, T., 1988. Family sense of coherence and family adaption. Journal of Marriage and the Family. 50:79-92.
Reference Type
BACKGROUND
Benzein E, Berg A. The Swedish version of Herth Hope Index--an instrument for palliative care. Scand J Caring Sci. 2003 Dec;17(4):409-15. doi: 10.1046/j.0283-9318.2003.00247.x.
Reference Type
BACKGROUND
Benzein EG, Hagberg M, Saveman BI. 'Being appropriately unusual': a challenge for nurses in health-promoting conversations with families. Nurs Inq. 2008 Jun;15(2):106-15. doi: 10.1111/j.1440-1800.2008.00401.x.
Reference Type
BACKGROUND
Benzein EG, Saveman BI. Health-promoting conversations about hope and suffering with couples in palliative care. Int J Palliat Nurs. 2008 Sep;14(9):439-45. doi: 10.12968/ijpn.2008.14.9.31124.
Reference Type
BACKGROUND
Benzein E, Olin C, Persson C. 'You put it all together' - families' evaluation of participating in Family Health Conversations. Scand J Caring Sci. 2015 Mar;29(1):136-44. doi: 10.1111/scs.12141. Epub 2014 Apr 9.
Reference Type
BACKGROUND
Bylund A, Arestedt K, Benzein E, Thorell A, Persson C. Assessment of family functioning: evaluation of the General Functioning Scale in a Swedish Bariatric Sample. Scand J Caring Sci. 2016 Sep;30(3):614-22. doi: 10.1111/scs.12269. Epub 2015 Nov 9.
Reference Type
BACKGROUND
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
Reference Type
BACKGROUND
Davydow DS, Gifford JM, Desai SV, Needham DM, Bienvenu OJ. Posttraumatic stress disorder in general intensive care unit survivors: a systematic review. Gen Hosp Psychiatry. 2008 Sep-Oct;30(5):421-34. doi: 10.1016/j.genhosppsych.2008.05.006. Epub 2008 Jul 30.
Reference Type
BACKGROUND
Dorell A, Isaksson U, Ostlund U, Sundin K. Family Health Conversations have Positive Outcomes on Families - A Mixed Method Research Study. Open Nurs J. 2017 Feb 28;11:14-25. doi: 10.2174/1874434601711010014. eCollection 2017.
Reference Type
BACKGROUND
Dowdy DW, Eid MP, Sedrakyan A, Mendez-Tellez PA, Pronovost PJ, Herridge MS, Needham DM. Quality of life in adult survivors of critical illness: a systematic review of the literature. Intensive Care Med. 2005 May;31(5):611-20. doi: 10.1007/s00134-005-2592-6. Epub 2005 Apr 1.
Reference Type
BACKGROUND
Dufault K, Martocchio BC. Symposium on compassionate care and the dying experience. Hope: its spheres and dimensions. Nurs Clin North Am. 1985 Jun;20(2):379-91.
Reference Type
BACKGROUND
Eggenberger SK, Nelms TP. Being family: the family experience when an adult member is hospitalized with a critical illness. J Clin Nurs. 2007 Sep;16(9):1618-28. doi: 10.1111/j.1365-2702.2007.01659.x.
Reference Type
BACKGROUND
Everson SA, Goldberg DE, Kaplan GA, Cohen RD, Pukkala E, Tuomilehto J, Salonen JT. Hopelessness and risk of mortality and incidence of myocardial infarction and cancer. Psychosom Med. 1996 Mar-Apr;58(2):113-21. doi: 10.1097/00006842-199603000-00003.
Reference Type
BACKGROUND
Everson SA, Kaplan GA, Goldberg DE, Salonen JT. Hypertension incidence is predicted by high levels of hopelessness in Finnish men. Hypertension. 2000 Feb;35(2):561-7. doi: 10.1161/01.hyp.35.2.561.
Reference Type
BACKGROUND
Frivold G, Slettebo A, Dale B. Family members' lived experiences of everyday life after intensive care treatment of a loved one: a phenomenological hermeneutical study. J Clin Nurs. 2016 Feb;25(3-4):392-402. doi: 10.1111/jocn.13059.
Reference Type
BACKGROUND
Fumis RR, Ranzani OT, Martins PS, Schettino G. Emotional disorders in pairs of patients and their family members during and after ICU stay. PLoS One. 2015 Jan 23;10(1):e0115332. doi: 10.1371/journal.pone.0115332. eCollection 2015.
Reference Type
BACKGROUND
Garvin P, Nilsson L, Carstensen J, Jonasson L, Kristenson M. Plasma levels of matrix metalloproteinase-9 are independently associated with psychosocial factors in a middle-aged normal population. Psychosom Med. 2009 Apr;71(3):292-300. doi: 10.1097/PSY.0b013e3181960e7f. Epub 2009 Feb 5.
Reference Type
BACKGROUND
Herth K. Abbreviated instrument to measure hope: development and psychometric evaluation. J Adv Nurs. 1992 Oct;17(10):1251-9. doi: 10.1111/j.1365-2648.1992.tb01843.x.
Reference Type
BACKGROUND
Jensen JF, Thomsen T, Overgaard D, Bestle MH, Christensen D, Egerod I. Erratum to: Impact of follow-up consultations for ICU survivors on post-ICU syndrome: a systematic review and meta-analysis. Intensive Care Med. 2015 Jul;41(7):1391. doi: 10.1007/s00134-015-3932-9. No abstract available.
Reference Type
BACKGROUND
Kose I, Zincircioglu C, Ozturk YK, Cakmak M, Guldogan EA, Demir HF, Senoglu N, Erbay RH, Gonullu M. Factors Affecting Anxiety and Depression Symptoms in Relatives of Intensive Care Unit Patients. J Intensive Care Med. 2016 Oct;31(9):611-7. doi: 10.1177/0885066615595791. Epub 2015 Jul 12.
Reference Type
BACKGROUND
Orwelius L, Kristenson M, Fredrikson M, Walther S, Sjoberg F. Hopelessness: Independent associations with health-related quality of life and short-term mortality after critical illness: A prospective, multicentre trial. J Crit Care. 2017 Oct;41:58-63. doi: 10.1016/j.jcrc.2017.04.044. Epub 2017 Apr 28.
Reference Type
BACKGROUND
Parker AM, Sricharoenchai T, Raparla S, Schneck KW, Bienvenu OJ, Needham DM. Posttraumatic stress disorder in critical illness survivors: a metaanalysis. Crit Care Med. 2015 May;43(5):1121-9. doi: 10.1097/CCM.0000000000000882.
Reference Type
BACKGROUND
Probst DR, Gustin JL, Goodman LF, Lorenz A, Wells-Di Gregorio SM. ICU versus Non-ICU Hospital Death: Family Member Complicated Grief, Posttraumatic Stress, and Depressive Symptoms. J Palliat Med. 2016 Apr;19(4):387-93. doi: 10.1089/jpm.2015.0120. Epub 2016 Feb 1.
Reference Type
BACKGROUND
Ridenour TA, Daley JG, Reich W. Factor analyses of the family assessment device. Fam Process. 1999 Winter;38(4):497-510. doi: 10.1111/j.1545-5300.1999.00497.x.
Reference Type
BACKGROUND
Sagy S, Dotan N. Coping resources of maltreated children in the family: a salutogenic approach. Child Abuse Negl. 2001 Nov;25(11):1463-80. doi: 10.1016/s0145-2134(01)00285-x.
Reference Type
BACKGROUND
Svenningsen H, Langhorn L, Agard AS, Dreyer P. Post-ICU symptoms, consequences, and follow-up: an integrative review. Nurs Crit Care. 2017 Jul;22(4):212-220. doi: 10.1111/nicc.12165. Epub 2015 Feb 17.
Reference Type
BACKGROUND
Tilburgs B, Nijkamp MD, Bakker EC, van der Hoeven H. The influence of social support on patients' quality of life after an intensive care unit discharge: A cross-sectional survey. Intensive Crit Care Nurs. 2015 Dec;31(6):336-42. doi: 10.1016/j.iccn.2015.07.002. Epub 2015 Aug 28.
Reference Type
BACKGROUND
Ullman AJ, Aitken LM, Rattray J, Kenardy J, Le Brocque R, MacGillivray S, Hull AM. Intensive care diaries to promote recovery for patients and families after critical illness: A Cochrane Systematic Review. Int J Nurs Stud. 2015 Jul;52(7):1243-53. doi: 10.1016/j.ijnurstu.2015.03.020. Epub 2015 Apr 4.
Reference Type
BACKGROUND
van Beusekom I, Bakhshi-Raiez F, de Keizer NF, Dongelmans DA, van der Schaaf M. Reported burden on informal caregivers of ICU survivors: a literature review. Crit Care. 2016 Jan 21;20:16. doi: 10.1186/s13054-016-1185-9.
Reference Type
BACKGROUND
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
Reference Type
BACKGROUND
Ware, JE., 1993. SF-36 health survey manual and interpretation guide., Boston., The New Health Institute, New England Medical Center.
Reference Type
BACKGROUND
Ware, J., Kosinski, M., Dewey, J., 2001. How to score version 2 of the SF-36 health survey. In.Rhode Island, USA: Quality Metric Incorporated; Lincoln.
Reference Type
BACKGROUND
WMA, The World Medical Association., 2013. Declaration of Helsinki - Etical Principals for 10 Medical Research Involving Human Subjects, 11 https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-12 medical-research-involving-human-subjects/
Reference Type
BACKGROUND
Wright, LM., Leahey, M., 2009. Nurses and families: A guide to family assessment and 14 intervention (5 Rev ed ed.). Pennsylvania: F.A. Davis Company.
Reference Type
BACKGROUND
Wright, LM., Leahey, M., 2013. Nurses and families: A guide to family assessment and 17 intervention (6th ed.). Philadelphia, PA: F.A. Davis.
Reference Type
BACKGROUND
Wahlin I, Ek AC, Idvall E. Patient empowerment in intensive care--an interview study. Intensive Crit Care Nurs. 2006 Dec;22(6):370-7. doi: 10.1016/j.iccn.2006.05.003. Epub 2006 Aug 4.
Reference Type
BACKGROUND
Agard AS, Egerod I, Tonnesen E, Lomborg K. From spouse to caregiver and back: a grounded theory study of post-intensive care unit spousal caregiving. J Adv Nurs. 2015 Aug;71(8):1892-903. doi: 10.1111/jan.12657. Epub 2015 Apr 1.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LinkoepingU74
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Pilot Trial of Family Partner - a Child Maltreatment Prevention Intervention
NCT04957394
COMPLETED
NA
Parent-child Interactions, Child Developmental Health, and Health System Costs at 6 Months Corrected Age
NCT03357458
COMPLETED
NA
Effectiveness of Child-Parent Relationship Therapy (CPRT)
NCT06087302
RECRUITING
NA
Problem Solving for Caregivers of Persons With Brain Injury
NCT00164645
UNKNOWN
PHASE3
Evaluation of Parenting Interventions to Decrease Family Risk for Child Maltreatment
NCT00586677
COMPLETED
NA
Supporting Parents Program: Intervention for Families in CPS
NCT01332851
COMPLETED
NA
Survivor Health and Resilience Education
NCT03327025
COMPLETED
NA
Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury
NCT04570930
COMPLETED
NA
Caregiver Outlook: An Evidence-based Intervention for the Chaplain Toolkit
NCT01768221
COMPLETED
NA
Tender Loving Care for Recurrent Pregnancy Loss
NCT06182878
RECRUITING
NA
The Four Supports Study: Family Support Intervention in Intensive Care Units
NCT01982877
COMPLETED
NA
Targeted Inpatient Navigation to Improve Care for Minority Children and Families
NCT03599674
COMPLETED
NA
A Behavioral Intervention With Foster Families
NCT05405972
COMPLETED
NA
Implementing an Intervention to Foster Resident and Family Engagement in Care Planning
NCT04026698
COMPLETED
NA
Resilient Families Open Pilot: Dyadic Resiliency Intervention
NCT06239571
ACTIVE_NOT_RECRUITING
NA
Families Coping With Mental Illness Program
NCT00435721
UNKNOWN
PHASE1
Multi-component Family Support Tool Intervention (FST)
NCT05019261
ACTIVE_NOT_RECRUITING
NA
Families Talking Together Plus: An Approach to Promote Sexual Delay and Strengthen Sexual Risk Avoidance Education
NCT04731649
COMPLETED
NA
Pennsylvania Abusive Head Trauma Prevention Program
NCT00727116
COMPLETED
NA
Preventing Child Maltreatment Through A Cellular-Phone Technology-Based Parenting Program
NCT01294475
COMPLETED
PHASE1/PHASE2
Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness
NCT03002896
COMPLETED
NA
Intensive Communication for Chronically Critically Ill
NCT01057238
COMPLETED
NA
Can Safety Planning Improve Perinatal Outcomes Among Pregnant Women Exposed to Intimate Partner Violence?
NCT00831831
WITHDRAWN
PHASE3
Family Mediation Program For At-Risk Youth
NCT01944748
COMPLETED
NA
Pilot of an Online Sexual Health Program
NCT06564025
RECRUITING
NA