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The Effects and Meaning of a Person-centred and Health-promoting Intervention in Home Care Services

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ClinicalTrials.gov Identifier: NCT02846246
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
David Edvardsson, Umeå University

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.

Condition or disease Intervention/treatment Phase
Staff and Older Persons With Home Care Service Other: Person-centred and health-promoting home care service Other: Care as usual Not Applicable

Detailed Description:

This is a non-randomised controlled trial with a before-after approach. The investigators will include 270 home care recipients >65 years, 270 family members and 65 staff in intervention group and control group respectively. Participants will be recruited from a municipality in northern Sweden. The intervention involves letting the person and family together with contact nurse prioritise care content and make rearrangements to make sure the home care service maximises the potential to satisfy psychosocial, physical, and functional needs and increasing health. Outcome assessment will focus on; a) quality of life (primary outcomes), thriving and satisfaction with care for older people, b) caregiver strain, informal caregiving engagement and satisfaction with care for relatives, c) job satisfaction and stress for care staff. Evaluation will be performed by questionnaires and interviews.

Person-centred home care services have the potential to improve the recurrently reported sub-standard experiences of home care services and the study result will hopefully lead the way in establish a person-centred and health-promoting model in aged care and living conditions for older people.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Effects and Meaning of a Person-centred and Health-promoting Intervention in Home Care Services: Study Protocol of a Non-randomised Controlled Trial
Actual Study Start Date : September 2015
Actual Primary Completion Date : May 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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
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.

Sham Comparator: Control
A usual care paradigm will guide the control units, i.e. a continuation with practice as usual.
Other: Care as usual
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.




Primary Outcome Measures :
  1. Change of Quality of Life assessed with the Nottingham Health Profile scale [ Time Frame: Baseline, 12 and 24 month follow-up ]
    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.

  2. Change of Quality of Life assessed with the EQ-5D [ Time Frame: Baseline, 12 and 24 month follow-up ]
    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.


Secondary Outcome Measures :
  1. Change in thriving assessed with the Thriving of Older People Assessment Scale [ Time Frame: baseline, 12 and 24 month follow-up ]
    Thriving will be assessed with The Thriving of Older People Assessment Scale which includes 32 items and consists of five sub-scales: resident attitude towards the place where they are living, quality of the care and care-givers, activities and peer relationships, opportunities to keep in touch with people and places of importance, and qualities in the physical environment. Each item has six answer alternatives on a Likert-scale ranging from No (1) to Yes, I agree completely (6). The Thriving of Older People Assessment Scale has been found to be valid and reliable.

  2. Change in satisfaction with home care service assessed with the Quality of Care from the Patients' Perspective [ Time Frame: baseline, 12 and 24 month follow-up ]
    Satisfaction with home care service will be measured with The Quality of Care from the Patients' Perspective which includes 64 items and consists of four dimensions: medical-technical competence (11 items), physical-technical conditions (10 items), identity-oriented approach (30 items) and social-cultural atmosphere (13 items). Each item should be answered in two ways; perceived reality and subjective importance. Perceived reality range between Not applicable (1) to Fully agree (5) on a five level Likert-scale while the subjective importance range between Of very great importance (1) to of little importance (4). The Quality of Care from the Patients' Perspective has been found to be valid and reliable.


Other Outcome Measures:
  1. Change in informal caregiver strain assessed with the Caregiver Burden Scale [ Time Frame: baseline, 12 and 24 month follow-up ]
    To assess informal caregiver strain, The Caregiver Burden Scale will be used. The scale includes 22 items in five dimensions: general strain, isolation, disappointment, emotional involvement, and environments. Response alternatives is a four-point Likert-scale: Not at all (1) to Often (4). The Caregiver Burden Scale has been found to be valid and reliable.

  2. Change in informal caregiving engagement assessed with the Resource Utilization in Dementia instrument [ Time Frame: baseline, 12 and 24 month follow-up ]
    Informal caregiver engagement will be assessed with The Resource Utilization in Dementia instrument which include three parts: personal activities of daily living (dressing/undressing, showering/bathing, washing, and moving), instrumental activities of daily living (cooking, shopping, washing, cleaning, taking care of economy, talking on the telephone, riding/driving car, and other transportations), and supervision (risks as fire, accidents, fall in house or outside etc.). The Resource Utilization in Dementia assesses resource utilization in terms of: hours of home care, number of days in hospital, number of visits to GP´s, physiotherapists, and informal care. The instrument has been found to be valid and reliable

  3. Change in satisfaction with care for relatives assessed with the Pyramid questionnaire [ Time Frame: baseline, 12 and 24 month follow-up ]
    Satisfaction with care will be assessed with The Pyramid questionnaire which includes 40 items in seven parts; information, staff professional skills, care, activity, contact, social support and relative participation. Response alternatives is a four-point Likert-scale: Yes, to a great degree to No, not at all. The scale has been found to be valid and reliable.

  4. Change in job satisfaction assessed with the Measure of Job Satisfaction [ Time Frame: baseline, 12 and 24 month follow-up ]
    Job satisfaction will be assessed with The Measure of Job Satisfaction which includes 37 items in five dimensions; personal satisfaction, satisfaction with workload, team spirit, training and professional support. Response alternatives is a five-point Likert-scale: Very dissatisfied (1) to Very Satisfied (5). The scale has been found to be valid and reliable.

  5. Change in stress of conscience assessed with the Stress of Conscience scale [ Time Frame: baseline, 12 and 24 month follow-up ]
    To assess stress of conscience, The Stress of Conscience scale will be used. the scale consists of ten items related to different health care situations, each question consists of an A and B part. The A parts' response alternatives are a six-point Likert-scale ranging from Never (0) to Every day (5). The questions are related to how often different situations arise at the workplace. The B parts are a ten centimetre visual analogue scale where each situations' impact on conscience are estimated. A total index can be calculated where a higher value means higher levels of stress of conscience. The Stress of Conscience scale has been found to be valid. A weakness is the absence of reliability test



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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion criteria for care recipients will be:

  • persons 65 years or older
  • living at home with granted HCS
  • have at least two visits per month, and
  • be Swedish speaking

Inclusion for family members:

  • be defined by the care recipients as his/her family member, and
  • Swedish speaking

Inclusion for staff:

  • 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

Exclusion Criteria

  • No exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02846246


Sponsors and Collaborators
Umeå University
Investigators
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Principal Investigator: David Edvardsson, Professor Umea University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Edvardsson, Professor, Umeå University
ClinicalTrials.gov Identifier: NCT02846246    
Other Study ID Numbers: 2016/04-31Ö
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by David Edvardsson, Umeå University:
aged care
health
home care services
person-centred care