ProFoUND PCC= A Program For a Userbased Nursing Development in Person-Centered Care, is a Project That Aims to Develop, Test and Evaluate Effects of a Co-created Intervention to Increase Person-centred Care in Residential Care Settings for Older People.
NCT07921953, Not applicable, Enrolling by invitation, Mälardalen University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | ProFoUND PCC= A Program For a Userbased Nursing Development in Person-Centered Care, is a Project That Aims to Develop, Test and Evaluate Effects of a Co-created Intervention to Increase Person-centred Care in Residential Care Settings for Older People. | ClinicalTrials.gov |
| NCT number | NCT07921953 | ClinicalTrials.gov |
| Status | Enrolling by invitation | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 180 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Mälardalen University | ClinicalTrials.gov |
| Conditions | Older Adults Living in Residential Care Facilities, Next of Kin, Relatives, Staff Working in Nursing Homes | ClinicalTrials.gov |
| Interventions | A person-centered care intervention in the ProFoUND-project | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Primary outcome is residents, next of kin and staff perceptions of PCC | From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31 | Perceptions of person-centred care among residents, next of kin, and staff will be assessed using the Person-centred Climate Questionnaire (patient, family, and staff versions, respectively). Questionnaire scores will be collected at baseline and at 3, 6, and 12 months following the intervention. Differences between intervention and control groups will be examined using independent samples t-tests and multivariable regression analyses. Repeated measurements over time will be included in longitudinal analyses to evaluate changes associated with the intervention. Likert scales 1-5 will be used. | ClinicalTrials.gov |
| Secondary | Residents thriving, health-related quality of life among residents and staff, next of kin- satisfaction with care and staff perceptions of PCC environment, in both the intervention and the control group, before and after the intervention | From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31 | Thriving will be assessed using the Thriving of Older People Assessment Scale (TOPAS). Scores will be collected at baseline and at 3, 6, and 12 months following the intervention. Differences between intervention and control groups and changes over time will be analyzed using independent samples t-tests and regression analyses. | ClinicalTrials.gov |
| Secondary | Health-related quality of life | From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31 | Health-related quality of life among residents and staff will be assessed using the EQ-5D. Scores will be collected at baseline and at 3, 6, and 12 months following the intervention. Differences between intervention and control groups and changes over time will be analyzed using independent samples t-tests and regression analyses. | ClinicalTrials.gov |
| Secondary | Next-of-kin satisfaction with care | From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31 | Satisfaction with care among next of kin will be assessed using the Pyramid Questionnaire. Scores will be collected at baseline and at 3, 6, and 12 months following the intervention. Differences between intervention and control groups and changes over time will be analyzed using independent samples t-tests and regression analyses. | ClinicalTrials.gov |
| Secondary | Perceptions of the person-centred care environment | From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31 | Staff perceptions of the care environment will be assessed using the Swedish version of the Person-centred Care Assessment Tool (P-CAT). Scores will be collected at baseline and at 3, 6, and 12 months following the intervention. Differences between intervention and control groups and changes over time will be analyzed using independent samples t-tests and regression analyses. | ClinicalTrials.gov |
| Other | Tertiary outcomes focuses on staff; Sick leave | From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31 | Staff sick leave will be assessed using administrative records. Differences over time between intervention and control nursing homes will be analyzed using longitudinal methods and Generalized Estimating Equations (GEE). | ClinicalTrials.gov |
| Other | Tertiary Outcome Measure 2: Staff turnover | From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31 | Staff turnover will be assessed using administrative records. Differences over time between intervention and control nursing homes will be analyzed using longitudinal methods and Generalized Estimating Equations (GEE). | ClinicalTrials.gov |
| Other | Tertiary Outcome Measure 3, Time spent on care | From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31 | Time spent on care will be assessed using a study-specific measure inspired by the Resource Utilization in Dementia (RUD) instrument. Differences over time between intervention and control groups will be analyzed using longitudinal methods and Generalized Estimating Equations (GEE). | ClinicalTrials.gov |
| Other | Tertiary Outcome Measure 4, Job satisfaction | From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31 | Job satisfaction among staff will be assessed using the Demand-Control-Support Questionnaire. Scores will be collected at baseline and at 3, 6, and 12 months following the intervention. Differences between intervention and control groups and changes over time will be analyzed using independent samples t-tests and regression analyses. | ClinicalTrials.gov |
| Other | Tertiary Outcome Measure 5, Stress of conscience | From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31 | Stress of conscience among staff will be assessed using the Stress of Conscience Questionnaire. Scores will be collected at baseline and at 3, 6, and 12 months following the intervention. Differences between intervention and control groups and changes over time will be analyzed using independent samples t-tests and regression analyses. | ClinicalTrials.gov |
| Other | Tertiary Outcome Measure 6, Capabilities among residents | From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31 | Capabilities will be assessed using the ICECAP-O instrument. Scores will be collected at baseline and at 3, 6, and 12 months following the intervention. Differences between intervention and control groups and changes over time will be analyzed using independent samples t-tests and regression analyses. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)