NCT01912157

Brief Summary

Handling of complex health situations (as defined by multimorbidity) in partnership: communication between romantic partners; subjective illness perception; coping with stressful experiences due to multimorbidity. Intervention : Expressive Writing about subjective illness perception vs. Writing about individual Time-Management Primary Endpoint: subjective Health (e.g. SF 12 questionnaire) Secondary Endpoints: Psychosocial Adjustments (Depression, somatic symptoms, quality of partnership and others)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2018

Completed
Last Updated

December 31, 2018

Status Verified

December 1, 2018

Enrollment Period

3.8 years

First QC Date

July 24, 2013

Last Update Submit

December 28, 2018

Conditions

Chronic DiseaseIllness Behavior

Outcome Measures

Primary Outcomes (1)

  • Subjective health (SF-12)

    3 months

Secondary Outcomes (1)

  • Psychosocial adjustments

    3 months

Study Arms (2)

No Intervention

PLACEBO COMPARATOR

The control condition are 3 sessions writing about individual time-management (placebo).

Behavioral: Expressive Writing

Expressive Writing

ACTIVE COMPARATOR

The intervention consists in 3 self-applied solitary written disclosure sessions (expressive writing).

Behavioral: Expressive Writing

Interventions

Expressive WritingBEHAVIORAL

The intervention consists in 3 self-applied solitary written disclosure sessions (expressive writing)

Expressive WritingNo Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • multimorbid condition (two or more chronic medical conditions)
  • patients living with romantic partner
  • very good oral and written command in German
  • written consent for participation by patient and partner

You may not qualify if:

  • Pregnancy
  • Mini Mental State less than 26
  • Substance Abuse
  • Patients in Palliative Situation
  • Patients isolated due to infectious diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Internal Medicine

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Chronic DiseaseIllness Behavior

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Lukas Zimmerli, MD

    University Hospital Zurich, Internal Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2013

First Posted

July 30, 2013

Study Start

July 1, 2013

Primary Completion

April 1, 2017

Study Completion

December 28, 2018

Last Updated

December 31, 2018

Record last verified: 2018-12

Locations

CH(1)