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. 2023 Aug 31;2023(8):CD013074. doi: 10.1002/14651858.CD013074.pub2

SOCIABLE 2017.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 8 months

  • Time frame: not reported

Participants
  • Setting: multicentre (2 centres in Baltimore)

  • Country: USA

  • Inclusion criteria: ≥ 60 years; English speaking; treated with in‐centre HD for at least 6 months at a facility in Baltimore, MD; and with limitations in physical function (difficulty in at least 1 of the following: bathing, dressing, walking across a room, grooming [referring to things done personally to ensure a clean and neat appearance], getting on or off the toilet, and getting on or off the bed) and low SES (less than high school education, unemployment, and/or household income < $25,000/year)

  • Exclusion criteria: inability to understand the informed consent process and give consent via signed written consent form


Baseline characteristics
  • Number (analysed/randomised): intervention group (6/6); control group (3/6)

  • Mean age ± SD (years): intervention group (69.5 ± 4.6); control group (68.6 ± 7.8)

  • Sex (M/F): intervention group (4/2); control group (3/3)

  • Dialysis type: HD

  • Dialysis vintage (years) (mean ± SD): not reported

  • Comorbidities

    • CVD: not reported

    • Diabetes: not reported

    • Hypertension: not reported

    • Depression (clinician diagnosis): not reported

Interventions Intervention classification
  • Non‐pharmacological intervention

  • Indication: study reporting fatigue


Intervention group
  • SOCIABLE (Seniors Optimizing Community Integration to Advance Better Living with ESRD) services


Control group
  • Usual care (patients receive SOCIABLE 6 months after the trial)


Cointerventions
  • Patients received a group of services called CAPABLE, which include home visits from a nurse and an occupational therapist, and a handyman for repairs if you need them and help with improving social support

Outcomes Outcomes reported
  • Fatigue outcome measures used: validation data available

  • Disability

    • Disability score for ADLs (Appendix 3): baseline, 4 and 8 months

      • Bathing

      • Dressing

      • Walking

      • Grooming

      • How difficult each one is to do

    • Lawton Instrumental ADLs (Appendix 3)

      • Hopping

      • Light housekeeping

      • Managing finances

  • Death

  • Pain

  • Depression

  • Physical function (energy, walking)

  • Tiredness

  • Satisfaction

    • Social Support and Satisfaction score (baseline and at 5 months)

  • Social network

    • Social Network score (baseline and at 5 months)

Notes Additional information
  • Funding: Johns Hopkins University

  • Conflicts of interest/disclosures: none

  • Trial registration identification number: NCT03055273

  • A priori published protocol was reported

  • Abstract but some information was reported in clinicaltrials.gov

  • Authors contacted: they said that the full information were reported in Crews DC, Delaney AM, Walker Taylor JL, Cudjoe TKM, Nkimbeng M, Roberts L, Savage J, Evelyn‐Gustave A, Roth J, Han D, Boyér LL, Thorpe RJ Jr, Roth DL, Gitlin LN, Szanton SL. Pilot Intervention Addressing Social Support and Functioning of Low Socioeconomic Status Older Adults With ESRD: The Seniors Optimizing Community Integration to Advance Better Living with ESRD (SOCIABLE) Study. Kidney Med. 2019 Jan 24;1(1):13‐20

  • Fatigue was addressed by therapist: it was reported "Although there is currently no standardized outcome measure for fatigue in HD patients, approaches such as our study, which address both the person and their environment, might offer a means to meaningfully reduce symptoms. Energyconservation techniques, such as those taught by our occupational therapist, might be particularly impact for HD patients."

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Sequence generation methods were not reported in sufficient detail to permit judgement. No imbalance between intervention groups was apparent
Allocation concealment (selection bias) Unclear risk Method of allocation concealment was not reported in sufficient detail to permit judgement. No imbalance between intervention groups was apparent
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote from the study suggested by authors: "Single blind study".
Comment: A single blind is considered as high risk of bias
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote from the study suggested by authors: "Our outcome assessor was masked to randomisation assignment."
Comment: Fatigue was not clearly reported, although the therapy helped people in addressing fatigue during their activities. However, subjective measures were used. Participant beliefs about the superiority/inferiority of either intervention could have influenced their assessment of the outcome, but there was no evidence that this was likely
Incomplete outcome data (attrition bias)
All outcomes High risk 9/12 participants completed the study (> 5% loss to follow‐up). Reasons were not provided
Selective reporting (reporting bias) High risk Information about the protocol were reported. It was not reported if multiple eligible outcome measurements (scales and time points) were pre‐specified. It was unclear if the reported approach to analysing this outcome was pre‐specified or influenced by the results. Fatigue at the end of treatment was not reported in a format that was extractable for meta‐analysis. All outcomes that should be addressed (fatigue, cardiovascular disease, and death) were not reported
Other bias Low risk There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding did not influence the data analysis and authors did not have conflicts of interest