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NCT Number: NCT05646615

Experiences and Health-related Quality of Life of Informal Caregivers of Dialysis Patients

The goal of this prospective, observational, multicentre cohort study is to assess the trajectory of the experiences (both positive and negative) and health-related quality of life (HRQOL) of informal caregivers of patients who start home dialysis, and compare these to experiences and HRQOL of informal caregivers of patients who start in-centre hemodialysis. The investigators hypothesise that informal caregivers of home dialysis patients experience more positive experiences, but also more negative experiences, and still have better HRQoL, compared with caregivers of in-centre HD patients. Participants will fill in five different validated questionnaires and questions on required support. Participants are asked to fill in the questionnaires after inclusion (i.e., start of dialysis), and at 6 and 12 months after start dialysis.

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Key information

Conditions

Peritoneal Dialysis Chronic Disease Disease Attributes Family Caregivers Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Hemodialysis, Home Informal Caregivers Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Reported Outcome Measures Quality of Life Renal Insufficiency Renal Insufficiency, Chronic Renal Replacement Therapy Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jessa Hospital, Hasselt, Belgium

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About this study

End-stage kidney disease, the need to start dialysis, and the choice for a home-based treatment or a centre-based treatment does not only have an effect on patients, but also on their informal caregivers like spouses and adult children providing care to the patient. In order to properly inform patients with end-stage kidney disease and their informal caregivers about the start of dialysis therapy and the choice of dialysis modality, it is important to discuss also what the caregiver can expect after the start of dialysis. However, available evidence regarding the course of caregiving experiences after start of dialysis is limited. The aim of this study is to assess the trajectory of the experiences (both positive and negative) and health-related quality of life (HRQoL) of caregivers of patients who start home dialysis, and compare these to experiences and HRQoL of caregivers of patients who start in-centre hemodialysis (HD). The investigators hypothesise that (co-residential) caregivers of home dialysis patients experience more positive experiences, but also more negative experiences, and still have better HRQoL, compared with caregivers of in-centre HD patients.

This study is a prospective, observational, multicentre cohort study which is an extension of the ongoing DOMESTICO study. DOMESTICO is a nationwide study in incident dialysis patients, investigating the effects of home dialysis on HRQoL in relation to clinical outcome and costs, in comparison to in-centre HD. Participants will fill in five different validated questionnaires and questions on required support. Participants are asked to fill in the questionnaires after inclusion (i.e., start of dialysis), and at 6 and 12 months after start dialysis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informal caregivers who care for a partner, family member, friend or loved one with end-stage kidney disease who is starting dialysis therapy and is included in the DOMESTICO study
  • 18 years or older

Treatment and study plan

Primary outcomes

  1. Changes in positive experiences of the caregiver (PES)

    Time frame: Baseline (start of dialysis), and 6 months and 12 months after start dialysis

    Positive Experiences Scale (PES): a Dutch 8-item validates questionnaire

Secondary outcomes

  1. Changes in negative experiences of the caregiver (EDIZ+)

    Time frame: Baseline (start of dialysis), and 6 months and 12 months after start dialysis

    'Ervaren Druk door Informele Zorg' or Experienced Burden by Informal Care (EDIZ+): a Dutch 15-item validated questionnaire

  2. Changes in negative experiences of the caregiver (CES-D)

    Time frame: Baseline (start of dialysis), and 6 months and 12 months after start dialysis

    Centre for Epidemiologic Studies Depression Scale (CES-D): a 20-item validated questionnaire

  3. Changes in health-related quality of life (HRQOL) (SF-12)

    Time frame: Baseline (start of dialysis), and 6 months and 12 months after start dialysis

    12-item Short Form (SF-12): validated questionnaire with eight domains

  4. Changes in health-related quality of life (HRQOL) (EQ5D-5L)

    Time frame: Baseline (start of dialysis), and 6 months and 12 months after start dialysis

    EuroQol-5D-5L (EQ5D-5L): validated questionnaire with five domains

Other outcomes

  1. Required support

    Time frame: Baseline (start of dialysis), and 6 months and 12 months after start dialysis

    Exploratory outcome, assessed by a questionnaire investigating in which domains caregivers would like extra support

Sponsors and collaborators

Lead sponsor

B.C. van Jaarsveld

Other

Collaborators

  • Admiraal de Ruyter Hospital
  • Alrijne Hospital
  • Amphia Hospital
  • Amsterdam UMC
  • Bernhoven Hospital
  • Canisius-Wilhelmina Hospital
  • Catharina Ziekenhuis Eindhoven
  • Deventer Ziekenhuis
  • Dialysis Center Beverwijk
  • Diapriva Dialysis Center, Amsterdam
  • Elkerliek Hospital
  • Flevoziekenhuis
  • Gelre Hospitals
  • Groene Hart Ziekenhuis
  • Haga Hospital
  • Isala
  • Jessa Hospital
  • Laurentius Hospital
  • Maasstad Hospital
  • Maxima Medical Center
  • Noordwest Ziekenhuisgroep
  • OLVG Oost
  • OLVG West
  • Radboud University Medical Center
  • Reinier de Graaf Groep
  • Rijnstate Hospital
  • Saxenburgh Group
  • Slingeland Hospital
  • St. Antonius Hospital
  • Tergooi Hospital
  • UMC Utrecht
  • VieCuri Medical Centre
  • ZorgSaam

Registry information

Official study title

Experiences and Health-related Quality of Life of Informal Caregivers of Patients Who Start Home Dialysis: a Prospective, Multicenter Cohort Study

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Dec 12, 2022
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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