Serious Mental IllnessNCT02420340
Using The HOPES Program in Transition Care
A study testing HOPES Program ("Helping Older People Experience Success") in people with Serious Mental Illness and Psychosocial Rehabilitation, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
This pilot study will collect information about the the potential to use an evidence-based skills training program designed for older people with serious mental illness (SMI), the Helping Older People Experience Success (HOPES) program, to help nursing home residents with SMI gain the skills needed to successfully… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Serious Mental Illness, Psychosocial Rehabilitation
- What is being tested?
- HOPES Program ("Helping Older People Experience Success")
- 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
- Sep 2014to Dec 2015
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary DSM-IV Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder as defined in participants' chart
- An expressed willingness to be discharged from Glencliff Home to the community.
- Voluntary informed consent for participation in the study by the participant or by the participant's legally designated guardian
Who cannot join
- Terminal physical illness OR significant medical instability
- Inability to speak or and understand English
- Primary or co-morbid diagnosis of dementia
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study will collect information about the the potential to use an evidence-based skills training program designed for older people with serious mental illness (SMI), the Helping Older People Experience Success (HOPES) program, to help nursing home residents with SMI gain the skills needed to successfully live in the community.
Read the detailed description
This pilot study will collect information about the the potential to use an evidence-based skills training program designed for older people with serious mental illness (SMI), the Helping Older People Experience Success (HOPES) program, to help nursing home residents with SMI gain the skills needed to successfully live in the community. Although HOPES was originally designed to help older people with SMI maintain their residence in the community, the curriculum holds promise for helping nursing home residents with SMI to learn how to return to life in the community. Positive findings would be used to develop a grant application for a larger study of HOPES in nursing home residents with SMI. To evaluate the feasibility and acceptability of HOPES in nursing home settings, the investigators will enroll up to 12 residents of the Glencliff Home in Glencliff, New Hampshire. Participants will be individuals interested in discharge from Glencliff and are willing to attend multiple weekly skills training classes and several assessment sessions. Study participation will last until 6 months after discharge from Glencliff.
- Being tested
- HOPES Program ("Helping Older People Experience Success")
- Keywords
- Serious Mental Illness, Psychosocial Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOPES Program ("Helping Older People Experience Success")Behavioural
Weekly group skills training classes aimed at improving skills and knowledge in areas related to successful living in the community including: independent living, healthy living, social skills, leisure skills, and management of health care.
| Study group | Role | What they receive |
|---|---|---|
| HOPES Group | Other | Participants will participate in twice weekly sessions of the HOPES program until curriculum is completed (approximately 1 year) or discharge from Glencliff home Receives: Behavioral: HOPES Program ("Helping Older People Experience Success") |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendence-70% attendance or higher of HOPES groups over the course of the intervention
attendance records
Measured: 12 months
Change in Functional Skills (University California San Diego Performance-Based Skills Assessment)
University California San Diego Performance-Based Skills Assessment
Measured: Baseline, 12 months, 6 month follow-up
Secondary outcomes (2)
Change in Medication Adherence and Management (Medication Management Ability Assessment)
Medication Management Ability Assessment
Measured: Baseline, 12 months, 6 month follow-up
Change in Social Skills (Social Skills Performance Assessment)
Social Skills Performance Assessment
Measured: Baeline, 12 months, 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startSep 2014
- Primary completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Serious Mental IllnessStudies 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
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Glencliff Home
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420340
- Sponsor's protocol ID
- 27956
- Status last verified
- Aug 2016
- First submitted
- 8 Apr 2015
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mueser KT, Pratt SI, Bartels SJ, Swain K, Forester B, Cather C, Feldman J. Randomized trial of social rehabilitation and integrated health care for older people with severe mental illness. J Consult Clin Psychol. 2010 Aug;78(4):561-73. doi: 10.1037/a0019629.
PubMed 20658812
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using The HOPES Program in Transition Care
- ClinicalTrials.gov ID
- NCT02420340
- Acronym / sponsor ID
- 27956
- Keywords
- Serious Mental Illness, Psychosocial Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Glencliff Home
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- First posted
- 17 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.
This pilot study will collect information about the the potential to use an evidence-based skills training program designed for older people with serious mental illness (SMI), the Helping Older People Experience Success (HOPES) program, to help nursing home residents with SMI gain the skills needed to successfully live in the community.
Detailed description
This pilot study will collect information about the the potential to use an evidence-based skills training program designed for older people with serious mental illness (SMI), the Helping Older People Experience Success (HOPES) program, to help nursing home residents with SMI gain the skills needed to successfully live in the community. Although HOPES was originally designed to help older people with SMI maintain their residence in the community, the curriculum holds promise for helping nursing home residents with SMI to learn how to return to life in the community. Positive findings would be used to develop a grant application for a larger study of HOPES in nursing home residents with SMI. To evaluate the feasibility and acceptability of HOPES in nursing home settings, the investigators will enroll up to 12 residents of the Glencliff Home in Glencliff, New Hampshire. Participants will be individuals interested in discharge from Glencliff and are willing to attend multiple weekly skills training classes and several assessment sessions. Study participation will last until 6 months after discharge from Glencliff.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HOPES Group | Other | Behavioral: HOPES Program ("Helping Older People Experience Success")Participants will participate in twice weekly sessions of the HOPES program until curriculum is completed (approximately 1 year) or discharge from Glencliff home |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary DSM-IV Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder as defined in participants' chart
- An expressed willingness to be discharged from Glencliff Home to the community.
- Voluntary informed consent for participation in the study by the participant or by the participant's legally designated guardian
Key exclusion criteria (3 listed)
- Terminal physical illness OR significant medical instability
- Inability to speak or and understand English
- Primary or co-morbid diagnosis of dementia
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 |
|---|---|---|
| HOPES Program ("Helping Older People Experience Success")Weekly group skills training classes aimed at improving skills and knowledge in areas related to successful living in the community including: independent living, healthy living, social skills, leisure skills, and management of health care. | Behavioural | HOPES Group |
Primary outcome
Attendence-70% attendance or higher of HOPES groups over the course of the intervention
Time frame: 12 months
attendance records
Change in Functional Skills (University California San Diego Performance-Based Skills Assessment)
Time frame: Baseline, 12 months, 6 month follow-up
University California San Diego Performance-Based Skills Assessment
2 secondary outcomes
Change in Medication Adherence and Management (Medication Management Ability Assessment)
Time frame: Baseline, 12 months, 6 month follow-up
Change in Social Skills (Social Skills Performance Assessment)
Time frame: Baeline, 12 months, 6 month follow-up
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 2 Aug 2016.
- Results publication: PubMed 20658812Mueser KT, Pratt SI, Bartels SJ, Swain K, Forester B, Cather C, Feldman J. Randomized trial of social rehabilitation and integrated health care for older people with severe mental illness. J Consult Clin Psychol. 2010 Aug;78(4):561-73. doi: 10.1037/a0019629.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOPES Program ("Helping Older People Experience Success") in people with Serious Mental Illness and Psychosocial Rehabilitation, run by Dartmouth-Hitchcock Medical Center 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 3 inclusion and 3 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 2 Aug 2016. 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?
Attendence-70% attendance or higher of HOPES groups over the course of the intervention (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02420340, which also lists 1 linked publication.
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 2 Aug 2016.