NCT02846246

Brief Summary

Current home care service are to a large extent task oriented with a limited focus on care recipient's involvement. Furthermore, studies have shown that low care recipients' involvement might decrease older people's quality of life. Person-centred care focusing on involvement has improved the quality of life and the satisfaction with care for older people in health care and nursing homes but there is a lack of knowledge about the effects and meaning of a person-centred interventions in aged care at home. Present study describes the evaluation of a person-centred and health-promoting intervention.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

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

September 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

2.7 years

First QC Date

July 12, 2016

Last Update Submit

January 17, 2024

Conditions

Keywords

aged carehealthhome care servicesperson-centred care

Outcome Measures

Primary Outcomes (2)

  • Change of Quality of Life assessed with the Nottingham Health Profile scale

    The Nottingham Health Profile scale will be used to assess quality of life. Nottingham health profile includes 38 items in six dimensions: energy level, pain, emotional reaction, sleep, social isolation, and physical abilities. Each item is answered through Yes/No statements and range from best (0) to worst (100) possible score. The Nottingham Health Profile has been found to be sensitive for changes, valid and reliable.

    Baseline, 12 and 24 month follow-up

  • Change of Quality of Life assessed with the EQ-5D

    As a complement, the EQ-5D will also be used to assess quality of life. The EQ-5D consists of two parts, a health state description and a visual analogue scale. The health state description comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels on a Likert-scale: none (0) to extreme (4). The visual analogue scale rates participants overall health between endpoints, worst imaginable health (0) and best imaginable health (100). EQ-5D has been found to be sensitive for changes and valid.

    Baseline, 12 and 24 month follow-up

Secondary Outcomes (2)

  • Change in thriving assessed with the Thriving of Older People Assessment Scale

    baseline, 12 and 24 month follow-up

  • Change in satisfaction with home care service assessed with the Quality of Care from the Patients' Perspective

    baseline, 12 and 24 month follow-up

Other Outcomes (5)

  • Change in informal caregiver strain assessed with the Caregiver Burden Scale

    baseline, 12 and 24 month follow-up

  • Change in informal caregiving engagement assessed with the Resource Utilization in Dementia instrument

    baseline, 12 and 24 month follow-up

  • Change in satisfaction with care for relatives assessed with the Pyramid questionnaire

    baseline, 12 and 24 month follow-up

  • +2 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

The experimental group will be introduced to a person-centred care model that involves shared decision making where the person with home care service and family together with contact nurse prioritise care content and make rearrangements to make sure the provided home care service maximises health.

Other: Person-centred and health-promoting home care service

Control

SHAM COMPARATOR

A usual care paradigm will guide the control units, i.e. a continuation with practice as usual.

Other: Care as usual

Interventions

Firstly, staff will take part in an educational program on the content and operationalization of the central theoretical components person-centeredness and health exploratory conversation. Secondly, staff will participate in supervised skill training in how to accomplish person-centered and health exploratory conversation. Thirdly, the staff will have a person-centred and health exploratory conversation with purpose to evaluate the extent to which current home care service practice meet the older person´s need and maintain or make rearrangement in provided care to maximise older people's health. Finally, staff will participate in clinical supervisory sessions with an aim to support and facilitate ongoing operationalization phase.

Intervention

The control group will be offered a lecture about dementia based on staff wishes and a usual care paradigm will guide the control units, i.e. a continuation with practice as usual. Control units will receive the intervention protocol and study results at the end of the study.

Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • persons 65 years or older
  • living at home with granted HCS
  • have at least two visits per month, and
  • be Swedish speaking
  • be defined by the care recipients as his/her family member, and
  • Swedish speaking
  • have an employment for more than 6 month in the HCS district at baseline, be a contact staff and
  • Swedish speaking
  • Care recipients who apply for HCS in the district during the study period will be offered the intervention but not be included in the evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Lamas K, Bolenius K, Sandman PO, Lindkvist M, Edvardsson D. Effects of a person-centred and health-promoting intervention in home care services- a non-randomized controlled trial. BMC Geriatr. 2021 Dec 18;21(1):720. doi: 10.1186/s12877-021-02661-5.

  • Bolenius K, Lamas K, Sandman PO, Lindkvist M, Edvardsson D. Perceptions of self-determination and quality of life among Swedish home care recipients - a cross-sectional study. BMC Geriatr. 2019 May 24;19(1):142. doi: 10.1186/s12877-019-1145-8.

  • Bolenius K, Lamas K, Sandman PO, Edvardsson D. Effects and meanings of a person-centred and health-promoting intervention in home care services - a study protocol of a non-randomised controlled trial. BMC Geriatr. 2017 Feb 16;17(1):57. doi: 10.1186/s12877-017-0445-0.

Study Officials

  • David Edvardsson, Professor

    Umea University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 27, 2016

Study Start

September 1, 2015

Primary Completion

May 1, 2018

Study Completion

June 1, 2018

Last Updated

January 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share