The Health Promoting Conversations for Families With a Critically Ill Relative

Family Health Clinical Trial

Official title:

The Health Promoting Conversations Intervention for Families With a Critically Ill Relative: A Pilot RCT

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03325049
• Other study ID #: LinkoepingU74
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: January 16, 2020

Study information

• Verified date: February 2021
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: January 16, 2020
• Est. primary completion date: January 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion criteria:

• dementia

• or other severe psychiatric illnesses

• drug abuse

• difficulties in understanding or reading the Swedish language

Related Conditions & MeSH terms

• Critical Illness
• Family Health

Intervention

Behavioral:
• The health-promoting conversations
The health-promoting conversations

Other:
• Usual Care
Usual Care

Locations

Country	Name	City	State
Sweden	Linköping university	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 12 months