EmpowermentEarly Phase 1NCT02391766
Group Intervention Empowerment Dementia
A Early Phase 1 study testing empowerment in people with Empowerment and Self Efficacy, run by Universidad Nacional de Rosario at 1 site in Argentina.
Trial summary
After diagnosis of a dementing illness, patients and their spouses have many concerns related to the disease and their future. This often leads to poor psychological well-being and reduced health-related quality of life (HRQoL) of the family. Read more about this study
- Who is it for?
- Ages 56 to 79 years
- Conditions the study is for
- Empowerment, Self Efficacy, Quality of Life
- What is being tested?
- empowerment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteArgentina
- Study dates
- Sep 2014to Oct 2015
- Phase
- Early Phase 1
- 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 56 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with dementia
- home dwelling with spouse
- not in the terminal phase of illness (estimated prognosis > one year)
- able to move independently (with or without devise)
- no severe hearing loss
Who cannot join
- neurological disease
- other medical conditions
- head trauma
- inability to move independently
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychosocial Group Intervention to Enhance Empowerment of People With Dementia and Their Caregivers: Study Protocol for a Randomized Controlled Trial
After diagnosis of a dementing illness, patients and their spouses have many concerns related to the disease and their future. This often leads to poor psychological well-being and reduced health-related quality of life (HRQoL) of the family. Support for Empowerment has been proven to be an effective method to improve prognosis of asthma, heart failure, osteoarthritis.and diabetes. However empowering interventions have not been studied in dementia. Therefore, the investigators aim was to examine, in an objective-oriented group intervention, the efficacy of empowerment support program (ESP) on the HRQoL of dementia patients and their spousal caregivers as well as on the sense of competence and psychological well-being of caregivers.
Methods: During the years 2014 to 15, 180 dementia patients and their spouses will be recruited from memory clinics or day centers and randomized into two arms: 90 patients for group-based ESP sessions including topics selected by the participants and the use of the by us for us guides, 90 patients will serve as controls in usual community care. Sessions may include topics on dementia, active lifestyle and prevention for cognitive decline, spousal relationship, future planning and emotional well-being. The patients and spouses will have their separate group sessions (ten participants per group) once a week for eight weeks.
Read the detailed description
Diagnoses and medications are confirmed from medical records provided by the couples. Charlson's comorbidity index is calculated to assess the severity and prognostic value of the participants' disease burden . Health-related quality of life (HRQoL) of the patients is assessed by using the 15D instrument Dementia patients are also assessed with the Clinical Dementia Rating Scale (CDR) the Mini Mental State Examination (MMSE) Other measurements include activities of daily living (ADL), instrumental activities of daily living (IADL) The presence of advance directives, such as a living will, are inquired about. Clinical measurements include height, weight, blood pressure and hand grip strength. The spousal caregivers are asked questions concerning the impact of their spouse's dementia diagnosis and they are assessed by the RAND-36 HRQoL instrument, 12-item General Health Questionnaire (GHQ-12) the Center for Epidemiologic Studies Depression Scale (CES-D) the randomization is performed by telephone to a randomization center. Couples are randomly allocated by means of computer-generated random numbers. Every randomization result will appear in the program after the participants name has been written and the person executing the randomization has confirmed the process with her initials. Participating couples are assessed by two study nurses three times over nine months: at baseline, three, and nine months. Use of health services, institutionalizations and mortality of both patients and caregivers will be retrieved from the central registers until 24 months from the baseline measurements.
- Conditions
- Empowerment, Self Efficacy, Quality of Life
- Being tested
- empowerment, usual care
- Keywords
- Self-management, Caregiving, Quality of life, Empowerment
- Medical subject headings
- Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
empowermentBehavioural
Also called by us for us guides
The groups of 10 participants meet once a week for eight weeks. last for four hours
topics on dementia and prevention of further cognitive decline, active lifestyle and emotional well-being, spousal relationship, future planning kinds of active learning used are working in pairs and brainstorming sessions.
usual careBehavioural
| Study group | Role | What they receive |
|---|---|---|
| empowerment group | Active comparator | empowerment intervention by us for us guides Receives: Behavioral: empowerment |
| no treatment group | Placebo comparator | dementia patients treatment as usual Receives: Behavioral: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients' HRQoL (15D)
patients' HRQoL (15D)
Measured: 8 weeks
Secondary outcomes (3)
caregivers' psychological well-being (GHQ-12)
caregivers' psychological well-being (GHQ-12)
Measured: 8 weeks
caregivers sense of competence (SCQ).
sense of self fulfillment and accomplishment in providing care to dementia patients
Measured: 8 weeks
spousal caregivers' HRQoL (RAND-36)
spousal caregivers' HRQoL (RAND-36)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmpowermentStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Rosario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, daniel serrani, Universidad Nacional de Rosario
- Investigators
- daniel serrani, Principal investigator, Universidad Nacional de Rosario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391766
- Sponsor's protocol ID
- PGIED01
- Other IDs
- ´GIED01
- Status last verified
- Mar 2015
- First submitted
- 4 Feb 2014
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Group Intervention to Enhance Empowerment of People With Dementia and Their Caregivers: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02391766
- Acronym / sponsor ID
- PGIED01
- Conditions
- Empowerment, Self Efficacy, Quality of Life
- Keywords
- Self-management, Caregiving, Quality of life, Empowerment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Universidad Nacional de RosarioUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 18 Mar 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.
After diagnosis of a dementing illness, patients and their spouses have many concerns related to the disease and their future. This often leads to poor psychological well-being and reduced health-related quality of life (HRQoL) of the family. Support for Empowerment has been proven to be an effective method to improve prognosis of asthma, heart failure, osteoarthritis.and diabetes. However empowering interventions have not been studied in dementia. Therefore, the investigators aim was to examine, in an objective-oriented group intervention, the efficacy of empowerment support program (ESP) on the HRQoL of dementia patients and their spousal caregivers as well as on the sense of competence and psychological well-being of caregivers.
Methods: During the years 2014 to 15, 180 dementia patients and their spouses will be recruited from memory clinics or day centers and randomized into two arms: 90 patients for group-based ESP sessions including topics selected by the participants and the use of the by us for us guides, 90 patients will serve as controls in usual community care. Sessions may include topics on dementia, active lifestyle and prevention for cognitive decline, spousal relationship, future planning and emotional well-being. The patients and spouses will have their separate group sessions (ten participants per group) once a week for eight weeks.
Detailed description
Diagnoses and medications are confirmed from medical records provided by the couples. Charlson's comorbidity index is calculated to assess the severity and prognostic value of the participants' disease burden . Health-related quality of life (HRQoL) of the patients is assessed by using the 15D instrument Dementia patients are also assessed with the Clinical Dementia Rating Scale (CDR) the Mini Mental State Examination (MMSE) Other measurements include activities of daily living (ADL), instrumental activities of daily living (IADL) The presence of advance directives, such as a living will, are inquired about. Clinical measurements include height, weight, blood pressure and hand grip strength. The spousal caregivers are asked questions concerning the impact of their spouse's dementia diagnosis and they are assessed by the RAND-36 HRQoL instrument, 12-item General Health Questionnaire (GHQ-12) the Center for Epidemiologic Studies Depression Scale (CES-D) the randomization is performed by telephone to a randomization center. Couples are randomly allocated by means of computer-generated random numbers. Every randomization result will appear in the program after the participants name has been written and the person executing the randomization has confirmed the process with her initials. Participating couples are assessed by two study nurses three times over nine months: at baseline, three, and nine months. Use of health services, institutionalizations and mortality of both patients and caregivers will be retrieved from the central registers until 24 months from the baseline measurements.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| empowerment group | Active comparator | Behavioral: empowermentempowerment intervention by us for us guides |
| no treatment group | Placebo comparator | Behavioral: usual caredementia patients treatment as usual |
Who may qualify
- Ages
- 56 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with dementia
- home dwelling with spouse
- not in the terminal phase of illness (estimated prognosis > one year)
- able to move independently (with or without devise)
- no severe hearing loss
Key exclusion criteria (4 listed)
- neurological disease
- other medical conditions
- head trauma
- inability to move independently
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 |
|---|---|---|
| empowermentAlso: by us for us guidesThe groups of 10 participants meet once a week for eight weeks. last for four hours topics on dementia and prevention of further cognitive decline, active lifestyle and emotional well-being, spousal relationship, future planning kinds of active learning used are working in pairs and brainstorming sessions. | Behavioural | empowerment group |
| usual care | Behavioural | no treatment group |
Primary outcome
patients' HRQoL (15D)
Time frame: 8 weeks
patients' HRQoL (15D)
3 secondary outcomes
caregivers' psychological well-being (GHQ-12)
Time frame: 8 weeks
caregivers sense of competence (SCQ).
Time frame: 8 weeks
spousal caregivers' HRQoL (RAND-36)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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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.
daniel serrani principal investigator
Universidad Nacional de Rosario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing empowerment in people with Empowerment and Self Efficacy, run by Universidad Nacional de Rosario at 1 site in Argentina.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Mar 2015. 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 Argentina. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
patients' HRQoL (15D) (time frame: 8 weeks). 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 18 Mar 2015.