ESRDSOCIABLENCT03055273
SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD
A study testing SOCIABLE in people with ESRD and Social Behavior, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to find out the best ways to help people with end stage kidney disease take care of their daily lives and improve their social functioning. Investigators want to learn whether services in the Community Aging in Place, Advancing Better Living for Elders (CAPABLE) study such as help with… Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- ESRD, Social Behavior, Physical Disability
- What is being tested?
- SOCIABLE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jun 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 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years and older
- End Stage Renal Disease on In-Center Hemodialysis for at least 6 months
- Functional limitations (difficulty in at least one of the following: bathing, dressing, walking across a room, grooming, getting on or off the toilet, getting on or off the bed);
- Low socioeconomic status (less than high School education, or household income <$25,000/year)
- Signed informed consent
Who cannot join
- Inability to understand the informed consent process and give consent via signed written consent form
Trial locations and contacts
1 site in 1 country.
About this study
This research is being done to find out the best ways to help people with end stage kidney disease take care of their daily lives and improve their social functioning.
Investigators want to learn whether services in the Community Aging in Place, Advancing Better Living for Elders (CAPABLE) study such as help with medications, muscle strengthening, balance training, pain management, changes to houses and improved social support can be tailored to fit the needs of older adults with kidney disease to help improve their ability to balance, walk, and take care of themselves.
People aged 60 years and older who have end stage kidney disease and have been receiving dialyses for at least 6 months, may join.
Read the detailed description
Questionnaires:
Participants will be asked to answer questions about:
- social support and social functioning
- pain and depression
- physical function
Study intervention:
Participants will be randomly assigned (by chance, like the flip of a coin) to one of two groups: participant either will receive SOCIABLE (Seniors Optimizing Community Integration to Advance Better Living with ESRD) services now, or will receive the same services in six months from now. Participants have a 50:50 chance of getting into each group
SOCIABLE services involve receiving visits with a nurse interviewer. Participants will decide how you want to improve your social function and social support.
Participants will also receive:
- a group of services called CAPABLE which include home visits from a nurse (RN) and an occupational therapist (OT) and a handyman for repairs if you need them and
- help with improving social support
All participants will receive 10 home visits (6 OT, 4 RN) plus minor home repairs and assistive devices over a 4 month period of time.
- Conditions
- ESRD, Social Behavior, Physical Disability
- Being tested
- SOCIABLE
- Medical subject headings
- Kidney Failure, Chronic, Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOCIABLEBehavioural
SOCIABLE services involve a nurse, and occupational therapist and a handyman to support function among older adults with end stage renal disease. There is particular emphasis on supporting the social function and the physical and everyday living function.
| Study group | Role | What they receive |
|---|---|---|
| SOCIABLE IMMEDIATE | Experimental | Receive services now Receives: Behavioral: SOCIABLE |
| SOCIABLE wait list | Active comparator | Receive services four months post-enrollment Receives: Behavioral: SOCIABLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Katz ADL
Questionnaire about Activities of Daily Living such as bathing, dressing, walking, grooming and how difficult each one is to do. 8 questions and they range from 0, meaning they have no difficulty to 2 which means they can not do it even with help.
Measured: baseline
Katz ADL
Questionnaire about Activities of Daily Living such as bathing, dressing, walking, grooming and how difficult each one is to do. 8 questions and they range from 0, meaning they have no difficulty to 2 which means they can not do it even with help.
Measured: 4 months post intervention
Katz ADL
Questionnaire about Activities of Daily Living such as bathing, dressing, walking, grooming and how difficult each one is to do. 8 questions and they range from 0, meaning they have no difficulty to 2 which means they can not do it even with help.
Measured: 8 months post intervention
Secondary outcomes (3)
Lawton Instrumental Activities of Daily Living (IADL) measure
This questionnaire measures participants' abilities to do Instrumental Activities of Daily Living such as shopping, light housekeeping, and managing finances. The scale ranges from 0 meaning they have no difficulty to 2 which means they can't do it even if they have help
Measured: Baseline
Lawton Instrumental Activities of Daily Living (IADL) measure
This questionnaire measures participants' abilities to do Instrumental Activities of Daily Living such as shopping, light housekeeping, and managing finances. The scale ranges from 0 meaning they have no difficulty to 2 which means they can't do it even if they have help
Measured: 4 months
Lawton Instrumental Activities of Daily Living (IADL) measure
This questionnaire measures participants' abilities to do Instrumental Activities of Daily Living such as shopping, light housekeeping, and managing finances. The scale ranges from 0 meaning they have no difficulty to 2 which means they can't do it even if they have help
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study startJun 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRDStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Roybal Center, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Deidra Crews, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055273
- Sponsor's protocol ID
- NA00097283
- Other IDs
- P30AG048773
- Acronym
- SOCIABLE
- Status last verified
- Aug 2017
- First submitted
- 31 Aug 2016
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD
- ClinicalTrials.gov ID
- NCT03055273
- Acronym / sponsor ID
- SOCIABLE / NA00097283
- Conditions
- ESRD, Social Behavior, Physical Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Roybal Center, National Institute on Aging (NIA)
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 16 Feb 2017 (actual)
- 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.
This research is being done to find out the best ways to help people with end stage kidney disease take care of their daily lives and improve their social functioning.
Investigators want to learn whether services in the Community Aging in Place, Advancing Better Living for Elders (CAPABLE) study such as help with medications, muscle strengthening, balance training, pain management, changes to houses and improved social support can be tailored to fit the needs of older adults with kidney disease to help improve their ability to balance, walk, and take care of themselves.
People aged 60 years and older who have end stage kidney disease and have been receiving dialyses for at least 6 months, may join.
Detailed description
Questionnaires:
Participants will be asked to answer questions about:
- social support and social functioning
- pain and depression
- physical function
Study intervention:
Participants will be randomly assigned (by chance, like the flip of a coin) to one of two groups: participant either will receive SOCIABLE (Seniors Optimizing Community Integration to Advance Better Living with ESRD) services now, or will receive the same services in six months from now. Participants have a 50:50 chance of getting into each group
SOCIABLE services involve receiving visits with a nurse interviewer. Participants will decide how you want to improve your social function and social support.
Participants will also receive:
- a group of services called CAPABLE which include home visits from a nurse (RN) and an occupational therapist (OT) and a handyman for repairs if you need them and
- help with improving social support
All participants will receive 10 home visits (6 OT, 4 RN) plus minor home repairs and assistive devices over a 4 month period of time.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOCIABLE IMMEDIATE | Experimental | Behavioral: SOCIABLEReceive services now |
| SOCIABLE wait list | Active comparator | Behavioral: SOCIABLEReceive services four months post-enrollment |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 60 years and older
- End Stage Renal Disease on In-Center Hemodialysis for at least 6 months
- Functional limitations (difficulty in at least one of the following: bathing, dressing, walking across a room, grooming, getting on or off the toilet, getting on or off the bed);
- Low socioeconomic status (less than high School education, or household income <$25,000/year)
- Signed informed consent
Key exclusion criteria (1 listed)
- Inability to understand the informed consent process and give consent via signed written consent form
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 |
|---|---|---|
| SOCIABLESOCIABLE services involve a nurse, and occupational therapist and a handyman to support function among older adults with end stage renal disease. There is particular emphasis on supporting the social function and the physical and everyday living function. | Behavioural | SOCIABLE IMMEDIATE, SOCIABLE wait list |
Primary outcome
Katz ADL
Time frame: baseline
Questionnaire about Activities of Daily Living such as bathing, dressing, walking, grooming and how difficult each one is to do. 8 questions and they range from 0, meaning they have no difficulty to 2 which means they can not do it even with help.
Katz ADL
Time frame: 4 months post intervention
Questionnaire about Activities of Daily Living such as bathing, dressing, walking, grooming and how difficult each one is to do. 8 questions and they range from 0, meaning they have no difficulty to 2 which means they can not do it even with help.
Katz ADL
Time frame: 8 months post intervention
Questionnaire about Activities of Daily Living such as bathing, dressing, walking, grooming and how difficult each one is to do. 8 questions and they range from 0, meaning they have no difficulty to 2 which means they can not do it even with help.
3 secondary outcomes
Lawton Instrumental Activities of Daily Living (IADL) measure
Time frame: Baseline
Lawton Instrumental Activities of Daily Living (IADL) measure
Time frame: 4 months
Lawton Instrumental Activities of Daily Living (IADL) measure
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 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.
Deidra Crews study chair
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOCIABLE in people with ESRD and Social Behavior, run by Johns Hopkins University at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 21 Aug 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Katz ADL (time frame: baseline). The study lists 3 primary outcomes in all. 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 21 Aug 2017.