Quality of LifeNCT06326905
CAPABLE Transplant
A study testing CAPABLE Transplant- Open Label Pilot in people with Quality of Life and Depression, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this mixed methods study is to adapt CAPABLE as CAPABLE Transplant to accomplish two things: 1) To resolve barriers to being classified as active on the Kidney Transplant (KT) waitlist, 2) as a surgical prehabilitation intervention targeting the pre-frail/ frail KT waitlist population. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Quality of Life, Depression, End Stage Renal Disease
- What is being tested?
- CAPABLE Transplant- Open Label Pilot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Deceased Donor Waitlist
- ≥18 years old
- Community dwelling
- Current Inactive status or active and had been inactive in the last 18 months for cardiovascular disease, frailty, obesity, social support, mental health, incomplete testing OR Active on the waitlist and low-income
Who cannot join
- Living Donor Waitlist
- Severe cognitive impairment
- Inactivity expected to last > 3 months (eg cancer treatment)
- >4 hospitalizations in the last 12 months
- Current home nursing, physical or occupational therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins School of Nursing
Baltimore, Maryland, 21205
Meagan Clemence, MS, 410-705-5808, mcleme26@jh.edu
About this study
Official title: Addressing Inactive Kidney Transplant Waitlist Status Through Adapting a Tailored Psycho-Social-Environmental Program
The purpose of this mixed methods study is to adapt CAPABLE as CAPABLE Transplant to accomplish two things: 1) To resolve barriers to being classified as active on the Kidney Transplant (KT) waitlist, 2) as a surgical prehabilitation intervention targeting the pre-frail/ frail KT waitlist population. It consists of two phases- an open label pilot and a randomized waitlist control trial, and 3) pilot test the feasibility and acceptability for CAPABLE Transplant in symptom and waitlist specific metrics amongst low-income active kidney transplant waitlist candidates.
Read the detailed description
CAPABLE is a multicomponent goal-directed program that reduces physical disability by working with the person and environment but has not been explored in prehabilitation research. The purpose of this study is to adapt CAPABLE, an existing evidence-based program for functionally and socio-economically vulnerable older adults, as a prehabilitation intervention for people with frailty awaiting KT.
As in CAPABLE, the delivery characteristics of CAPABLE Kidney Transplant consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (~6 home visits for ≤ 1hour), a registered nurse (RN) (~4 home visits for ≤ 1hour) and a handy worker (HW).
In earlier phases, research team members conducted preliminary activities to design the CAPABLE Kidney Transplant intervention using Human-Centered Design techniques.
This study will seek to accomplish two aims:
- To iteratively refine the CAPABLE -Transplant prototype for those currently KT inactive or those who are active and low-income on the waitlist.
- To pilot test the CAPABLE-Transplant intervention
The investigators will collect feedback during the open label pilot to further refine the intervention that will be tested as part of the randomized control trial.
- Being tested
- CAPABLE Transplant- Open Label Pilot, CAPABLE Transplant- Randomized Control Trial
- Keywords
- Activities of Daily Living, Instrumental Activities of Daily Living, Physical Function, Executive Function, Home, Intervention, Kidney Transplant, End Stage Renal Disease
- Medical subject headings
- Depression, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPABLE Transplant- Open Label PilotBehavioural
As in CAPABLE, the delivery characteristics of CAPABLE Transplant consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (~6 home visits for ≤ 1hour), a registered nurse (RN) (~4 home visits for ≤ 1hour) and a handy worker (HW).
Adaptations targeting those currently KT inactive will be made on a per-client basis as part of the open-label pilot. We will further refine and develop the intervention by receiving feedback from the open label pilot participants and CAPABLE clinicians who implemented the pilot to gain their perspective of the acceptability and feasibility of implementing the CAPABLE-Transplant intervention. Based on this feedback, the study team will have developed an adapted iteration of the prototype.
CAPABLE Transplant- Randomized Control TrialBehavioural
As in CAPABLE, the delivery characteristics of CAPABLE Transplant consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (~6 home visits for ≤ 1hour), a registered nurse (RN) (~4 home visits for ≤ 1hour) and a handy worker (HW). Refinements based on the open label pilot results will be included.
| Study group | Role | What they receive |
|---|---|---|
| Open Label Pilot | Experimental | The Open Label Pilot will include testing the CAPABLE Transplant intervention with 3 individuals on the waitlist. Receives: Behavioral: CAPABLE Transplant- Open Label Pilot |
| Randomized Control Pilot- Intervention Arm | Experimental | After the open label pilot, 20 participants will be randomized to the CAPABLE Transplant intervention. They will be assessed at baseline, after the 4 month intervention, and after the waitlist control arm. Receives: Behavioral: CAPABLE Transplant- Randomized Control Trial |
| Randomized Control Pilot- Waitlist Control Arm | Active comparator | The waitlist control group, 20 participants, will receive the intervention after they have served as controls to the immediate treatment group, ensuring all participants have access to the intervention. Receives: Behavioral: CAPABLE Transplant- Randomized Control Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waitlist-status as assessed by data obtained by the National Kidney Registry
Death (any cause), Time Inactive
Change of waitlist status (inactive to active, delisting)
Measured: 0, 16 weeks, 32 weeks
Secondary outcomes (11)
Change in self-efficacy as assessed by the Coping Self-Efficacy Instrument
Coping Self-Efficacy is a 13 item instrument on a scale of 0 ('can't do at all') to 10 ('certain can do'). A higher score indicates higher level of self-efficacy when implementing coping strategies. Score range 0-130.
Measured: Baseline, 16 weeks, 32 weeks
Change in self-efficacy as assessed by the Self-Efficacy of Chronic Disease Management Instrument
Self-Efficacy of Chronic Disease Management Instrument is a 6 item instrument on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident). Lower scores indicate lower self-efficacy as indicated by confidence. Score range 6-60.
Measured: Baseline, 16 weeks, 32 weeks
Change in Pain as assessed by the Brief Pain Inventory
The Brief Pain Inventory - is a 4-item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. For the 10 point scale, 0 indicated no pain and 10 indicates the worst imaginable pain. Score range 0-40.
Measured: Baseline, 16 weeks, 32 weeks
Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8)
The PHQ-8 contains 8 questions, with a 0-3 scale. A score of 10 or greater is considered major depression, 20 or more is severe major depression. Score range 0-30.
Measured: Baseline, 16 weeks, 32 weeks
Change in Social engagement as assessed by the Lubben Social Network Scale
The Lubben Social Network Scale is a 7-item questionnaire that measures the size of social networks of family and friends. The score ranges between 0 and 30, with higher scores indicated more social engagement.
Measured: Baseline, 16 weeks, 32 weeks
Change in Social engagement as assessed by the Krause-Borawski-Clark Support Interactions Scale
The Krause-Borawski-Clark Support Interactions Scale is a 10-item self-reported questionnaire that measures social interactions. The scale is broken down into different domains; scores range from very often (4); fairly often (3); once in a while (2); never (1) or binary-- satisfied (1) or not satisfied (0) depending on domain within the questionnaire. Items are summed to form a single composite score range 10-40, Higher scores on the scale is associated with better personal perception and social support.
Measured: Baseline, 16 weeks, 32 weeks
Change in Fatigue/Quality of Life as assessed by the Kidney disease Quality of Life Scale
The Kidney disease Quality of Life Short Form is a 20-item self-report outcome measure for patients on dialysis. Higher scores indicate better health-related quality of life. Scores range from 0-100.
Measured: Baseline, 16 weeks, 32 weeks
Change in Frailty as assessed by the Fried Frailty Phenotype
The Fried Frailty Phenotype contains 5 criteria: unintentional weight loss >10lbs >5% of body mass in the last year, weakness (handgrip strength measurement), exhaustion (based on the Center for Epidemiological Studies Depression Scale), slow gait (walking time over a distance), and low physical activity. People who had none of the criteria were considered non-frail, people who had 1 and 2 criteria were considered pre-frail, and people who had ≥3 criteria were considered frail.
Measured: Baseline, 16 weeks, 32 weeks
Change in Health Team Communication as assessed by the CollaboRATE Scale Measure
The CollaboRATE scale measure is a 3 item self-report questionnaire on patient's shared decision making. It is scored on a 10-point anchored scale, ranging from 0 ("no effort was made") to 9 ("every effort was made"). Higher scores indicate more shared decision making.
Measured: Baseline, 16 weeks, 32 weeks
Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale
The assessment contains 8 questions with answers that are either a score of 0 or 1. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men to avoid potential gender bias.
Measured: Baseline, 16 weeks, 32 weeks
Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living
6 questions, each 1 point for a total score of 6. A score closer to 6 indicates high patient independence.
Measured: Baseline, 16 weeks, 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start25 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Waitlist Control Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Hladek, PhD, Principal investigator, Johns Hopkins School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326905
- Sponsor's protocol ID
- IRB00437750
- Other IDs
- K23DK133677-01A1
- Status last verified
- Jul 2026
- First submitted
- 18 Mar 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Inactive Kidney Transplant Waitlist Status Through Adapting a Tailored Psycho-Social-Environmental Program
- ClinicalTrials.gov ID
- NCT06326905
- Acronym / sponsor ID
- IRB00437750
- Keywords
- Activities of Daily Living, Instrumental Activities of Daily Living, Physical Function, Executive Function, Home, Intervention, Kidney Transplant, End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Mar 2024 (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.
The purpose of this mixed methods study is to adapt CAPABLE as CAPABLE Transplant to accomplish two things: 1) To resolve barriers to being classified as active on the Kidney Transplant (KT) waitlist, 2) as a surgical prehabilitation intervention targeting the pre-frail/ frail KT waitlist population. It consists of two phases- an open label pilot and a randomized waitlist control trial, and 3) pilot test the feasibility and acceptability for CAPABLE Transplant in symptom and waitlist specific metrics amongst low-income active kidney transplant waitlist candidates.
Detailed description
CAPABLE is a multicomponent goal-directed program that reduces physical disability by working with the person and environment but has not been explored in prehabilitation research. The purpose of this study is to adapt CAPABLE, an existing evidence-based program for functionally and socio-economically vulnerable older adults, as a prehabilitation intervention for people with frailty awaiting KT.
As in CAPABLE, the delivery characteristics of CAPABLE Kidney Transplant consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (~6 home visits for ≤ 1hour), a registered nurse (RN) (~4 home visits for ≤ 1hour) and a handy worker (HW).
In earlier phases, research team members conducted preliminary activities to design the CAPABLE Kidney Transplant intervention using Human-Centered Design techniques.
This study will seek to accomplish two aims:
- To iteratively refine the CAPABLE -Transplant prototype for those currently KT inactive or those who are active and low-income on the waitlist.
- To pilot test the CAPABLE-Transplant intervention
The investigators will collect feedback during the open label pilot to further refine the intervention that will be tested as part of the randomized control trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Waitlist Control Trial
| Arm | Type | Receives |
|---|---|---|
| Open Label Pilot | Experimental | Behavioral: CAPABLE Transplant- Open Label PilotThe Open Label Pilot will include testing the CAPABLE Transplant intervention with 3 individuals on the waitlist. |
| Randomized Control Pilot- Intervention Arm | Experimental | Behavioral: CAPABLE Transplant- Randomized Control TrialAfter the open label pilot, 20 participants will be randomized to the CAPABLE Transplant intervention. They will be assessed at baseline, after the 4 month intervention, and after the waitlist control arm. |
| Randomized Control Pilot- Waitlist Control Arm | Active comparator | Behavioral: CAPABLE Transplant- Randomized Control TrialThe waitlist control group, 20 participants, will receive the intervention after they have served as controls to the immediate treatment group, ensuring all participants have access to the intervention. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Deceased Donor Waitlist
- ≥18 years old
- Community dwelling
- Current Inactive status or active and had been inactive in the last 18 months for cardiovascular disease, frailty, obesity, social support, mental health, incomplete testing OR Active on the waitlist and low-income
Key exclusion criteria (5 listed)
- Living Donor Waitlist
- Severe cognitive impairment
- Inactivity expected to last > 3 months (eg cancer treatment)
- >4 hospitalizations in the last 12 months
- Current home nursing, physical or occupational therapy
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 |
|---|---|---|
| CAPABLE Transplant- Open Label PilotAs in CAPABLE, the delivery characteristics of CAPABLE Transplant consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (~6 home visits for ≤ 1hour), a registered nurse (RN) (~4 home visits for ≤ 1hour) and a handy worker (HW). Adaptations targeting those currently KT inactive will be made on a per-client basis as part of the open-label pilot. We will further refine and develop the intervention by receiving feedback from the open label pilot participants and CAPABLE clinicians who implemented the pilot to gain their perspective of the acceptability and feasibility of implementing the CAPABLE-Transplant intervention. Based on this feedback, the study team will have developed an adapted iteration of the prototype. | Behavioural | Open Label Pilot |
| CAPABLE Transplant- Randomized Control TrialAs in CAPABLE, the delivery characteristics of CAPABLE Transplant consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (~6 home visits for ≤ 1hour), a registered nurse (RN) (~4 home visits for ≤ 1hour) and a handy worker (HW). Refinements based on the open label pilot results will be included. | Behavioural | Randomized Control Pilot- Intervention Arm, Randomized Control Pilot- Waitlist Control Arm |
Primary outcome
Waitlist-status as assessed by data obtained by the National Kidney Registry
Time frame: 0, 16 weeks, 32 weeks
Death (any cause), Time Inactive Change of waitlist status (inactive to active, delisting)
11 secondary outcomes
Change in self-efficacy as assessed by the Coping Self-Efficacy Instrument
Time frame: Baseline, 16 weeks, 32 weeks
Change in self-efficacy as assessed by the Self-Efficacy of Chronic Disease Management Instrument
Time frame: Baseline, 16 weeks, 32 weeks
Change in Pain as assessed by the Brief Pain Inventory
Time frame: Baseline, 16 weeks, 32 weeks
Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8)
Time frame: Baseline, 16 weeks, 32 weeks
Change in Social engagement as assessed by the Lubben Social Network Scale
Time frame: Baseline, 16 weeks, 32 weeks
Change in Social engagement as assessed by the Krause-Borawski-Clark Support Interactions Scale
Time frame: Baseline, 16 weeks, 32 weeks
Change in Fatigue/Quality of Life as assessed by the Kidney disease Quality of Life Scale
Time frame: Baseline, 16 weeks, 32 weeks
Change in Frailty as assessed by the Fried Frailty Phenotype
Time frame: Baseline, 16 weeks, 32 weeks
Change in Health Team Communication as assessed by the CollaboRATE Scale Measure
Time frame: Baseline, 16 weeks, 32 weeks
Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale
Time frame: Baseline, 16 weeks, 32 weeks
Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living
Time frame: Baseline, 16 weeks, 32 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Quality of Life
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
Not yet recruitingPhase 2
The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity
Doxorubicin Induced Cardiotoxicity, Doxorubicin Induced Cardiomyopathy
Recruiting
Aquatic Versus Land-Based Exercise in Women With Lipedema
Lipedema
Not yet recruitingObservational study
Development and Validation of a Chinese Quality of Life Scale for Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension (PAH), Quality of Life
Recruiting
Basic Body Awareness Therapy in Individuals With Migraine
Migraine
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.
Melissa Hladek, PhD principal investigator
Johns Hopkins School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAPABLE Transplant- Open Label Pilot in people with Quality of Life and Depression, 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa Hladek, PhD (4106142418, mhladek1@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waitlist-status as assessed by data obtained by the National Kidney Registry (time frame: 0, 16 weeks, 32 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 20 Jul 2026.