Family HealthNCT03325049
The Health Promoting Conversations for Families With a Critically Ill Relative
A study testing The health-promoting conversations in people with Family Health, run by Linkoeping University at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Family Health
- What is being tested?
- The health-promoting conversations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2017to 16 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- dementia
- or other severe psychiatric illnesses
- drug abuse
- difficulties in understanding or reading the Swedish language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Health Promoting Conversations Intervention for Families With a Critically Ill Relative: A Pilot RCT
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.
Read the detailed description
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).
- Conditions
- Family Health
- Being tested
- The health-promoting conversations, Usual Care
- Keywords
- Family Relations, Family Health, Intervention study, Social support, Intensive care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The health-promoting conversationsBehavioural
The health-promoting conversations
Usual CareOther
Usual Care
| Study group | Role | What they receive |
|---|---|---|
| The health-promoting conversations | Experimental | 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. Receives: Behavioral: The health-promoting conversations |
| Control Arm | Active comparator | Usual Care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
family functioning
e GF is a 12-item scale designed to measure self-reported perceived overall 15 family functioning (Wright and Leahey, 2009, 2013). Each item is rated on a four-point 16 Likert scale: 'strongly agree' = 1, 'agree' = 2, 'disagree' = 3 and 'strongly disagree' = 4. The 17 scale scores ranges from 12 to 48, with lower scores indicating better family functioning. The 18 GF was translated into Swedish and has been pilot tested in Swedish samples, and the scale 19 has shown satisfactory reliability and acceptable validity of 0.90 (Bylund et al., 2015). The 20 reliability coefficient alpha was 0.45 in this study.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start1 Sep 2017
- Primary completion16 Jan 2019
- Study completion16 Jan 2020
Why it stopped: We have closed the study because of slow inclusion of families
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Family HealthStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized controlled pilot study used a pre-test, post-test design with intervention and control groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Susanna Ågren, Linkoeping University
- Investigators
- Susanna Ågren, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325049
- Sponsor's protocol ID
- LinkoepingU74
- Status last verified
- Feb 2021
- First submitted
- 15 Sep 2017
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26032101Alderfer 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.
PubMed 17905801Antonovsky, A., Sourani, T., 1988. Family sense of coherence and family adaption. Journal of Marriage and the Family. 50:79-92.
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.
PubMed 14629644Benzein 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.
PubMed 18476853Benzein 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.
PubMed 19060795Benzein 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.
PubMed 24720612Bylund 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.
PubMed 26555951Charlson 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.
PubMed 3558716Davydow 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.
PubMed 18774425Dorell 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.
PubMed 28400891Dowdy 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.
PubMed 15803303Dufault 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.
PubMed 3846980Eggenberger 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.
PubMed 17727583Everson 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.
PubMed 8849626
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Health Promoting Conversations Intervention for Families With a Critically Ill Relative: A Pilot RCT
- ClinicalTrials.gov ID
- NCT03325049
- Acronym / sponsor ID
- LinkoepingU74
- Conditions
- Family Health
- Keywords
- Family Relations, Family Health, Intervention study, Social support, Intensive care unit
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We have closed the study because of slow inclusion of families
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 16 Jan 2019 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This randomized controlled pilot study used a pre-test, post-test design with intervention and control groups
| Arm | Type | Receives |
|---|---|---|
| The health-promoting conversations | Experimental | Behavioral: The health-promoting conversationsIn 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. |
| Control Arm | Active comparator | Other: Usual CareUsual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- dementia
- or other severe psychiatric illnesses
- drug abuse
- difficulties in understanding or reading the Swedish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The health-promoting conversationsThe health-promoting conversations | Behavioural | The health-promoting conversations |
| Usual CareUsual Care | Other | Control Arm |
Primary outcome
family functioning
Time frame: up to 12 months
e GF is a 12-item scale designed to measure self-reported perceived overall 15 family functioning (Wright and Leahey, 2009, 2013). Each item is rated on a four-point 16 Likert scale: 'strongly agree' = 1, 'agree' = 2, 'disagree' = 3 and 'strongly disagree' = 4. The 17 scale scores ranges from 12 to 48, with lower scores indicating better family functioning. The 18 GF was translated into Swedish and has been pilot tested in Swedish samples, and the scale 19 has shown satisfactory reliability and acceptable validity of 0.90 (Bylund et al., 2015). The 20 reliability coefficient alpha was 0.45 in this study.
Results and safety
The study was stopped early (reason given: We have closed the study because of slow inclusion of families). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Background: PubMed 26032101Ahlberg 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.
- Background: PubMed 17905801Alderfer 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.
- BackgroundAntonovsky, A., Sourani, T., 1988. Family sense of coherence and family adaption. Journal of Marriage and the Family. 50:79-92.
- Background: PubMed 14629644Benzein 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.
- Background: PubMed 18476853Benzein 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.
- Background: PubMed 19060795Benzein 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.
- Background: PubMed 24720612Benzein 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.
- Background: PubMed 26555951Bylund 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.
- Background: PubMed 3558716Charlson 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.
- Background: PubMed 18774425Davydow 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.
- Background: PubMed 28400891Dorell 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.
- Background: PubMed 15803303Dowdy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanna Ågren, PhD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The health-promoting conversations in people with Family Health, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: We have closed the study because of slow inclusion of families). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
family functioning (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03325049, which also lists 39 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.