Clinical trial NCT03325049: The Health Promoting Conversations for Families With a Critically Ill Relative
Official title: The Health Promoting Conversations Intervention for Families With a Critically Ill Relative: A Pilot RCT
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Family Health
Keywords: Family Relations
Family Health
Intervention study
Social support
Intensive care unit
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2017-10-30
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized controlled pilot study used a pre-test, post-test design with intervention and control groups
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: family functioning
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping university
Study officials:
affiliation: Linkoeping University
name: Susanna Ågren, PhD
role: PRINCIPAL_INVESTIGATOR
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