DepressionNCT02408081
Family Focused Nursing for Elderly Medical Patients
A study testing Family Focused Nursing in people with Depression, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether Family Focused Nursing are effective in the treatment of elderly medical patients with respect to prevalence of depression Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Family Focused Nursing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- acute hospitalized
- an expected hospitalization of minimum two days
- speak and understand Danish
- signed informed consent
Who cannot join
- dementia (evaluated by the Mini Mental State Examination [MMSE] < 24)
- terminally ill patients whose survival rate is assessed to be less than a month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Family-Focused Nursing for Elderly Medical Patients and Their Family: A Randomized Controlled Trial
The purpose of this study is to determine whether Family Focused Nursing are effective in the treatment of elderly medical patients with respect to prevalence of depression
Read the detailed description
Psychosocial issues such as lack of social support and symptoms of depression, are risk factors associated to readmission for elderly medical patients. Families with elderly members in general want to be involved in the caring and want to maintain a close relation to their elderly family member. However, disease in a single family can have a negative effect on all members and may result in dysfunction of the family. International guidelines recommend that the patient's relatives are involved in patient education as well as the treatment. Family interventions might contribute to decline depression and readmissions, besides enhanced quality of life and family function among elderly medical patients and their next of kin.
- Conditions
- Depression
- Being tested
- Family Focused Nursing
- Keywords
- Depression, Family functioning, Family Focused Nursing, Quality of life
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Focused NursingBehavioural
Also called Family, Nursing, Elderly
All patients receive treatment as usual. Additionally, patients in the intervention arm receives family focused nursing consultations which are structured as sessions focusing on change, improvement and/or maintenance of family function within cognitive, affective and behavioral knowledge. Each session is organized and individualized according to the wishes and needs for education and counseling of the families within a period of one months.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | No intervention | Pharmacological treatment, patient information and counselling according to international and national guidelines by health professionals specialized in elderly medical patients. |
| Family Focused Nursing | Experimental | Family Focused Nursing and treatment as usual Receives: Behavioral: Family Focused Nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms assessed by 9 points measured on the Geriatric Depression Scale
The effect of intervention on primary outcome are investigated as longitudinal data at seven days and six month. The data are analysed using mixed models
Measured: Baseline, 7 days and 6 months after the intervention
Secondary outcomes (3)
Change in family function score on Brief Family Assessment Measure III
The effect of intervention on secondary outcome are investigated as longitudinal
Measured: 7 days and 6 months
Change in health related quality of life on Medical Outcomes Study Short Form, SF-8
The effect of intervention on secondary outcome are investigated as longitudinal
Measured: 7 days and 6 months
Change in time spent between hospitalization
The effect of intervention on secondary outcome are investigated as longitudinal
Measured: 7 days and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: not able to be completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen
- Responsible party
- Principal investigator, Birte Oestergaard, University of Southern Denmark
- Investigators
- Penille W Perboell, MHSc, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408081
- Sponsor's protocol ID
- UNR-H-6-2014-109-5
- Status last verified
- Oct 2017
- First submitted
- 31 Mar 2015
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Focused Nursing for Elderly Medical Patients and Their Family: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02408081
- Acronym / sponsor ID
- UNR-H-6-2014-109-5
- Conditions
- Depression
- Keywords
- Depression, Family functioning, Family Focused Nursing, Quality of life
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not able to be completed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen
- Study start
- Apr 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Family Focused Nursing are effective in the treatment of elderly medical patients with respect to prevalence of depression
Detailed description
Psychosocial issues such as lack of social support and symptoms of depression, are risk factors associated to readmission for elderly medical patients. Families with elderly members in general want to be involved in the caring and want to maintain a close relation to their elderly family member. However, disease in a single family can have a negative effect on all members and may result in dysfunction of the family. International guidelines recommend that the patient's relatives are involved in patient education as well as the treatment. Family interventions might contribute to decline depression and readmissions, besides enhanced quality of life and family function among elderly medical patients and their next of kin.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | –Pharmacological treatment, patient information and counselling according to international and national guidelines by health professionals specialized in elderly medical patients. |
| Family Focused Nursing | Experimental | Behavioral: Family Focused NursingFamily Focused Nursing and treatment as usual |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- acute hospitalized
- an expected hospitalization of minimum two days
- speak and understand Danish
- signed informed consent
Key exclusion criteria (2 listed)
- dementia (evaluated by the Mini Mental State Examination [MMSE] < 24)
- terminally ill patients whose survival rate is assessed to be less than a month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Focused NursingAlso: Family, Nursing, ElderlyAll patients receive treatment as usual. Additionally, patients in the intervention arm receives family focused nursing consultations which are structured as sessions focusing on change, improvement and/or maintenance of family function within cognitive, affective and behavioral knowledge. Each session is organized and individualized according to the wishes and needs for education and counseling of the families within a period of one months. | Behavioural | Family Focused Nursing |
Primary outcome
Change in depressive symptoms assessed by 9 points measured on the Geriatric Depression Scale
Time frame: Baseline, 7 days and 6 months after the intervention
The effect of intervention on primary outcome are investigated as longitudinal data at seven days and six month. The data are analysed using mixed models
3 secondary outcomes
Change in family function score on Brief Family Assessment Measure III
Time frame: 7 days and 6 months
Change in health related quality of life on Medical Outcomes Study Short Form, SF-8
Time frame: 7 days and 6 months
Change in time spent between hospitalization
Time frame: 7 days and 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Penille W Perboell, MHSc principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Focused Nursing in people with Depression, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms assessed by 9 points measured on the Geriatric Depression Scale (time frame: Baseline, 7 days and 6 months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.